On June 18^th, 2019, ArisGlobal presented the webinar “Effective Automated Content Management Strategies for Today’s Successful Medical Information Managers.” When polled, 40% of attendees rated “speed of delivering information” as their top challenge, yet only 13% have adopted automated component authoring to help remedy the situation. That and other interesting insights are shared in this first of a two-part blog series.

Nearly two years ago, ArisGlobal published a “Mobility and Medical Affairs” blog that kicked off with a quote from Bain & Company’s June 2017 industry brief: “The most competitive pharma companies in the coming decade will be masters of data and digital technologies.”

That quote remains just as true today as it did in 2017. Today’s pharmaceutical and medical device consumer/ patient is digitally savvy and has higher expectations for quick responses to their queries. Physicians are now becoming less reliant on sales representatives and are turning to more scientific sources of information. These and other factors are placing a lot of pressure on medical information (MI) teams to provide accurate and timely responses at greater speed.

What is your top percieved challenge when it comes to managing your medical affairs content?

SPEED OF DELIVERING INFORMATION 40% 40%
VERSION CONTROL 20% 20%
CONTENT DISSEMINATION 33% 33%
GLOBAL CONSIDERATION 0% 0%
OTHERS 7% 7%

Given this reality, increasing volumes in calls by patients, healthcare professionals (HCPs) and other stakeholders are on the rise and likely to continue as product launches, new communication channels, and other factors of our modern age continue to unfold. While standard response documents (SRDs) are commonly used to help create consistent responses, they require authoring, review, approval, distribution, maintenance, version control, and often need to be translated into local languages, all of which exponentially multiplies the effort involved.

Automated content management can help streamline, enable workflow-driven capabilities, component authoring, and more throughout the creation, management, and distribution of SRDs – all areas where ArisGlobal has been working closely with top customers to advance. Yet, when webinar attendees were asked to what extent they have already adopted component authoring for SRDs, nearly 13% were fully implemented while nearly 19% were in progress. At just under 69%, most attendees are still holding back on this effort, but in another year’s time these percentages will most certainly increase as MI departments become more knowledgeable for how automation can ease the complexity of medical information processes.

Have you adopted component authoring for standard response documents?

NO 68.8% 68.8%
IMPLEMENTATION IS UNDER PROGRESS 18.6% 18.6%
YES, FULLY IMPLEMENTED 12.6% 12.6%

In our concluding blog, to be published next week, we will share what we think are the necessary functionality today’s content management system needs to provide, especially with the move to self-service. If waiting until then is not ideal, view the on-demand webinar and read our article, “The Role of Artificial Intelligence Within Pharmacovigilance and Medical Information.”

The post While “Speed of Delivery” Tops the List of Medical Affairs Challenges, Active Use of Automation Is Still in the Early Stages appeared first on ArisGlobal.

At this year’s DIA Global Annual Conference, ArisGlobal presented an Innovation Theater session, “Getting More Value from Your Data Through a Unified, Cross-Department Platform.” Wim Cypers, Senior Vice President of Regulatory, highlighted use cases where automation can be used to improve business processes to enhance data quality and improved business process efficiencies. He shared how a unified platform can reach beyond regulatory and how regulatory data can improve compliance across your life sciences organization. For those that couldn’t attend this session, this blog shares some of his collective insights

Industry Trends: Moving from Documents to Data

Over the past 50 years, the evolution of regulatory information management has undergone significant change, moving from the paper submissions era of the ‘70s, to the digitalized era of the ‘80s and ‘90s, and onto the document exchange era of the past twenty years.

In the past several years, regulatory departments have been investing in regulatory information management capabilities to overcome long-standing challenges such as:

Lack of centralization of approved product data
Poor collaboration with affiliates and other resources
Manual ways of sharing or extracting information from other departments
New standards compliance (such as xEVMPD, IDMP, and UDI)
Costly and time-consuming upgrades to avoid technology obsolescence with changing regulations

The data in such RIM systems is vitally important, especially as there is now increasing regulatory agency demand for quality metrics to assist them in determining the state and quality of a product and facility. Given this focus on metrics, regulatory departments are now looking at how to converge disparate regulatory information management (RIM) capabilities; implementing best practices for data governance roles and responsibilities; and creating formal information architecture aligned to data standards for effective documentation, storage and sharing of regulatory information.

Improving Data Quality

The emphasis that regulatory authorities place on quality systems creates important considerations for the regulatory department within life sciences organizations. Looking beyond data submission compliance as the only end goal, regulatory departments are now asking “how can we deliver quality data faster and at lower cost, and that is in compliance and links departmental data together?”

Regulatory departments have historically been the gateway for sharing data in a structured format with the agencies, and the responsibility to share quality metrics data will most likely fall on them. This means going beyond compliance by establishing a platform from which the rest of the organization can consolidate data and proactively measure metrics internally. With this approach, regulatory departments can provide the rest of the organization with the insights they need to determine which manufacturing sites are not meeting the quality metrics cut-off and are therefore potentially at risk of an inspection.

Alignment Between Data and Documents

Within this expanded role, regulatory departments need harmonized processes, a central technology platform for data collection, workﬂow collaboration and electronic gateway communication to meet health authority structured data exchange objectives. This is where automation capabilities can perform an important role.

Methods such as structured content authoring, which automatically populates routine documents with already-approved sections of content and approved data, enables more collaborative contributions and promote re-use.

The ability to automatically generate a document based on data, and to separate a document into building blocks for re-use these across multiple documents ensures that data is aligned with document content.

Using Regulatory Data to Benefit Your Organization

As regulatory departments transform their operations to more productively meet today’s challenges and plan for those in the years ahead, success will be realized in marrying the concepts of documents and data to create a single source of truth as opposed to just extracting data from documents. By using existing data that resides in systems of clinical, R&D, manufacturing and regulatory departments, regulatory departments can create a uniﬁed underlying source of product and process information – a central data hub that is data-standard agnostic and yet can cater to multiple submission requirements.

From this underlying source, regulatory can digitally and automatically author dossier documents using natural language generation technologies. The same underlying data can also be used to cater to multiple data submission requirements (such as XEVMPD, IDMP, SPL and UDI).

Under this transformative approach, the benefit to life sciences companies is significant. Increased compliance, better alignment between data and documents, improved efficiencies, and the ability to focus on what matters. In the end, this all delivers improved products and patients.

We encourage you to view our recent on-demand webcast for more details on Next-Generation Structured Authoring: Seamless Synchronization between Data and the Document. Have any questions? Send an email to info@arisglobal.com.

The post Getting More Value from Your Data Through a Unified, Cross-Department Platform appeared first on ArisGlobal.

On June 18th, 2019, ArisGlobal presented the webinar “Effective Automated Content Management Strategies for Today’s Successful Medical Information Managers.” In this final blog of our two-part series, we share how the move to self-service is creating a clear paradigm shift and impacting the content management strategy of today’s MI departments.

By 2020, 67% of physicians will be digital natives and will prefer obtaining medical information on specific medications through digital channels, and by 2025, 75% of our global workforce will be accomplished by millennials who are extremely comfortable with digital technology[1].

With billions of mobile health app downloads (source: Statista 2019) as an indicator, today’s patients are also now more digitally empowered than ever before, with access to healthcare information just a few keystrokes and clicks away. Patients now expect immediate responses to their healthcare concerns. Additionally, the emergence of patient support groups and new stakeholders, such as “patient opinion leaders” and “digital opinion leaders” blogging on healthcare issues, add to the complexity facing medical information (MI) departments.

This reality impacts both the rise in call volumes that MI departments are experiencing as well as the public’s move toward self-service. ArisGlobal believes that pharma companies need to proactively develop and launch self-service engagement strategies and capabilities that allow:

HCPs and patients to easily search via mobile apps or online desktop,
The ability to submit inquiries if appropriate content is not found
Provide an auto-response mechanism through chat bots for on-label requests

Artificial intelligence is becoming mainstream and will enable MI systems to deliver capabilities. Leveraging AI, medical information is broken down into manageable components based on patient information and FAQs. User-entered text/questions are parsed, and keywords are identified. Based on the questions, AI will select and present the most appropriate responses. If a response is not found or the user is not satisfied with the response, the user can then chat live or submit an inquiry.

We admit then to being surprised by our webinar attendees’ response when asked whether their company currently delivers such self-service content access. Sixty-two percent replied “no.” The 23.1% who are planning a self-service portal and the combined 15.4% who either have a full-service portal or publish all documents on their website are ahead of the curve on this front.

Do you currently provide self-service content to HCPs and Sales representatives/MSLs?

NO 61.5% 61.5%
NO, BUT WE ARE PLANNING TO DEVELOP A SELF SERVICE PORTAL 23.1% 23.1%
YES, ALL THE DOCUMENTS ARE PUBLISHED ON THE WEBSITE 7.7% 7.7%
YES, WE USE A SELF SERVICE PORTAL 7.7% 7.7%

Developing an effective, long-term content strategy and the components necessary – one that factors into account the paradigm shift toward self-service – is covered in more detail in the webinar, now available on-demand. We also invite you to read our article “The Role of Artificial Intelligence Within Pharmacovigilance and Medical Information” to learn more.

The post Moving to Self-Service: A Key Component of an Effective Automated Content Management Strategy for Medical Information Managers appeared first on ArisGlobal.

On June 5th, 2019, ArisGlobal held a webinar focused on the “Key Use Cases of Automation in Pharmacovigilance.” During that event, 84% of attendees indicated a significant increase in their case volumes over the last five years. Although the stage of planned or currently adopted levels of automation varied, attendees had some thoughts to share about where automation should be prioritized once adopted.

In our June 2019 webinar “Key Use Cases of Automation in Pharmacovigilance”, Dr. Tims Thimmanna and Dr. Swati Nayak presented how automation addresses specific areas of PV-related changes – case intake, data entry, dictionary coding, duplicate check, follow up, narrative generation, causality assessment and submission. During the webinar, we asked respondents where their automation priorities were across the case processing workflow. The results were highly distributed, which reaffirmed our belief that automation can have a positive effect in many different places, as we’ve seen from working on automation use cases directly with some of the industry’s largest organizations.

Indeed, robotic process automation (RPA) can be leveraged to automate manual, repetitive steps and is best used in cases where human intervention and decision-making is not typically required, whereas artificial Intelligence (AI) and its sub-categories can mimic human decision-making to read, interpret, and analyze source documents and determine the appropriate actions required. For example, natural language processing systems can be used in literature surveillance and review of medical literature. Image recognition systems can be useful in medical review and assessment of laboratory reports. Machine learning can be used in performing logical steps of case processing.

Overall, these cognitive computing tools can augment the performance of a company’s pharmacovigilance staff, reduce the volume of manual and repetitive tasks and allow a PV team to focus on more value-add activities.

Which areas of PV are you most likely to automate?

DUPLICATE CHECK 22% 22%
CASE INTAKE 19% 19%
NARRATIVE GENERATION 16% 16%
QUALITY CHECK 15% 15%
FOLLOW-UP PROCESSING 15% 15%
END-TO-END CASE PROCESSING 13% 13%

(This is Blog Three in a Series of Three Blogs from the Key Use Cases of Automation in Pharmacovigilance Webinar.)

To learn more about the insights shared and questions asked and answered, view the on-demand Key Use Cases of Automation in Pharmacovigilance webinar and read our white paper “Cognitive Computing in Pharmacovigilance: Revamping Drug Safety Using an Advanced Computing System.”

We also invite you to register to attend a complimentary lunch-and-learn workshop on July 18^th in Cambridge, MA. “Building an Automation-Centric Approach to Drug Safety.” During the two-hour workshop, Edwin Raj, Senior Director and Head of Safety Operations, AMAG Pharmaceuticals will share how they have replaced their legacy Argus system and are moving away from repetitive manual tasks by automating patient data collection from any source, which reduces errors and increases cost savings. Space is limited, so register soon if you are available to attend.

White Papers

The Role of Technology in Vaccine Pharmacovigilance

Pharmacovigilance and EU GDPR Compliance

Webcast

Key Use Cases of Automation in Pharmacovigilance

From Push and Pull with EMA: A Modern Take on Triaging Adverse Events

Need More Information?

Connect with Us

Need More Information?

The post Design test for safety post with the collaterals appeared first on ArisGlobal.

An excerpt from the ArisGlobal white paper “Regulatory 2025: Developing an Effective 10-year Strategy for Technology-Enabled Regulatory Transformation,” shares how the increasing regulatory agency demand for quality metrics in data submissions is driving the need for structured data:

“The emphasis that regulatory authorities place on quality systems creates important considerations for the regulatory department, not just in the intermediate term, but for a progressive 2025 strategy.”

With so many inspections to manage, agencies are taking a quantitative approach to determine which companies to inspect first. To do this, they are proposing that companies send them raw manufacturing data, which agencies can use to calculate quality metrics to determine the state and quality of the product and facility. Some of the metrics proposed by agencies such as the U.S. Food and Drug Administration (FDA) are lot acceptance rate (LAR), product quality complaint rate (PQCR) or invalidated out-of-specification (OOS) rate (IOOSR). Based on these metrics, the agency plans to prioritize sites that are deemed risky.

Since regulatory departments have historically been the gateway for sharing data in a structured format with the agencies, the responsibility to share quality metrics data will most likely fall on them. To meet the data requirements, it’s imperative that they have efficient processes and tools in place to facilitate communication with other departments that provide the raw data, so that it can be compiled in a structured messaging format, reviewed, and submitted electronically to the agencies. This is similar to what will be required by 2020 to meet IDMP standards.”

In a June 20^th webinar on “Next-Generation Structured Authoring: Seamless Synchronization Between Data and the Document”, Wim Cypers, ArisGlobal Senior Vice President, Regulatory, shared how we are currently in a transition and transformation phase where the move to a structured approach presents the challenge of ensuring that data and documents are in sync.

Just where do life sciences organizations stand today in this transformation phase? When asked ‘Does your organization have any initiatives related to structured content authoring?” webinar attendees showed that 62% are in some stage of discussion, development or use compared to 38% who responded “No.” Clearly there is a lot of interest being raised and questions asked, and a year from now a greater percentage of companies will be moving into development and use of structured content authoring.

Does your organization have any initiatives related to Structured Content authoring?

YES, SOLUTION IN PRODUCTION USE 8% 8%
YES, DEVELOPMENT ONGOING 15% 15%
YES, CONCEPTUALLY BEING DISCUSSED 39% 39%
NO 38% 38%

The move to structured content, linguistics and translations, and standardization of terminology are just a few of the challenges covered during the webinar. In our second webinar polling question, “Does your organization have any Master Data Management initiative related to standardization of terminology?” the majority of 58% indicated that development was ongoing with another 8% sharing that an MDM solution was in production use.

Does your organization have any Master Data Management initiative related to standardization of terminology?

YES, SOLUTION IN PRODUCTION USE 8% 8%
YES, DEVELOPMENT ONGOING 58% 58%
YES, CONCEPTUALLY BEING DISCUSSED 26% 26%
NO 8% 8%

Structured content authoring brings advantages – greater consistency, improved cost control, and improved efficiency . This was echoed by attendees who vastly deemed all as important in the final polling question, which asked “What is the main motivation for your organization to consider a solution for Structured Authoring?”

What is the main motivation for your organization to consider a solution for structured authoring?

DATA QUALITY AND CONSISTENCY 18% 18%
IMPROVED EFFICIENCY AND TIME SAVING 0% 0%
BOTH ARE IMPORTANT 82% 82%

To be successful, Structured Authoring requires both technical structured authoring capabilities along with process improvements such as collaborative authoring. Finally, the technical solution is only as strong as the data governance built around the data. Wim’s final piece of advice is to build a stepwise approach to implementation.

To learn more, view the on-demand “Next-Generation Structured Authoring: Seamless Synchronization Between Data and the Document” webinar and read our white paper “Regulatory 2025: Developing an Effective 10-year Strategy for Technology-Enabled Regulatory Transformation.”

Request a Demo

The post Regulatory Structured Authoring: Next Steps in Achieving Greater Efficiencies and Consistency appeared first on ArisGlobal.

Miami, FL. August 28, 2019 – ArisGlobal, LLC, a leading provider of life sciences software that automates core drug development functions for over 250 life sciences companies, will present a session titled “How to Fully Leverage Automation in PV – A Real Case Study” at the upcoming World Drug Safety Congress Europe 2019, September 10-11, 2019 at the Hotel Hilton Amsterdam, Amsterdam, Netherlands.

Aman Wasan, Vice President, Global Pharmacovigilance & Global Client Partners Group, ArisGlobal, will present the session scheduled for September 10, 14:10-14:30, as part of the “BIG DATA, AUTOMATION & AI IN SAFETY track.” He will discuss how the cost of conducting pharmacovigilance is increasing each year as the volume of cases received by pharmaceutical companies grows exponentially. Life Sciences organizations are forced to find innovative ways to process the data resulting from this growth with limited resources. Aman will also share insights from a recent case study on how recent advancements in Artificial Intelligence technology – spanning cognitive computing, machine learning, natural language processing – can be combined with OCR and Rule Based Automation to enable organizations to address this challenge.

“The time is now for the pharmaceutical industry to embrace automation technology and stay abreast with the progress made in other industries,” said Aman. “Cognitive computing tools can augment the expertise of pharmacovigilance staff, reduce the volume of manual repetitive tasks, and allow them to focus on more intelligent, value-added tasks. My session will share the efficiencies gained from a real case study.”

ArisGlobal an exhibitor and will be showcasing LifeSphere Safety, its cognitive computing platform, in Booth #2. Attendees are invited to meet with ArisGlobal staff to learn about its innovative and leading pharmacovigilance and safety platform.

About ArisGlobal

ArisGlobal is a visionary technology company that’s transforming the way today’s most successful life sciences companies develop breakthroughs and bring new products to market. The ArisGlobal LifeSphere® cognitive technology platform integrates machine-learning capabilities to automate the core functions of the product lifecycle. Designed with deep expertise and a long-term perspective that spans more than 30 years, our cognitive platform delivers actionable insights, boosts efficiency, ensures compliance, and lowers total cost of ownership through multi-tenancy.

Headquartered in the United States, ArisGlobal has regional offices in Europe, India, Japan and China. Visit arisglobal.com or follow ArisGlobal on LinkedIn and Twitter.

The post ArisGlobal Safety Expert to Present “How to Fully Leverage Automation in PV – A Real Case Study” at World Drug Safety Congress Europe appeared first on ArisGlobal.

Miami, FL. September 12, 2019 – ArisGlobal today announced details of its annual Life Sciences Technology Summit (AGLSTS 2019), taking place October 1^st – 3^rd at the Miami Beach EDITION hotel in Miami Beach, Florida. The 3-day event will bring together senior executives, IT and business practitioners, and industry experts across drug safety, regulatory affairs, clinical development, and medical affairs to discuss how a unified platform and automation technology can transform the drug development process.

Over the course of several networking opportunities, attendees will be able to engage with industry peers to discuss new ways to reduce the high costs of technology ownership, enable better decision making, and improve productivity.

Debuting New Automation Solutions Within ArisGlobal’s LifeSphere^® Platform

At AGLSTS 2019, ArisGlobal will debut new additions to its LifeSphere portfolio that leverage cognitive computing technology to increase speed and efficiency by automating manual, resource-intensive tasks. These new technologies include:

A cutting edge, cloud-based drug safety system built on a completely new architecture powered by AWS that incorporates the latest in robotic process automation and cognitive computing. In an industry first, the system, developed in direct partnership with regulatory agencies and several leading pharmaceutical companies, offers seamless out-of-the-box unification with medical affairs and product quality functions.
A new solution to automate the entire medical literature monitoring process, leveraging natural language processing to bring efficiency and compliance to a historically manual process.

Building upon the success of AGLSTS 2018, this year’s summit will include breakout agendas for four different user groups: Safety, Regulatory, Clinical, and Medical Affairs. This will give all attendees the opportunity to take part in general sessions as well as respective sessions tailored to sharing and discussing insights specific to those areas.

“We’re very excited to introduce new innovations within our LifeSphere portfolio at AGLSTS 2019,” said Sam Stein, ArisGlobal’s Vice President, Marketing. “We can’t wait to share these product updates with the world, and we look forward to hearing from leading industry voices on a wide range of topics covering automation, compliance and digital transformation best practices. We look forward to seeing everyone in beautiful Miami Beach.”

To learn more or to register to attend AGLSTS 2019, please visit: https://www.arisglobal.com/aglsts2019

About ArisGlobal

ArisGlobal is a visionary technology company that’s transforming the way today’s most successful life sciences companies develop breakthroughs and bring new products to market. LifeSphere^® integrates our proprietary Nava^® cognitive computing engine to automate all core functions of the drug development lifecycle. Designed with deep expertise and a long-term perspective that spans more than 30 years, LifeSphere^® boosts efficiency, ensures compliance, delivers actionable insights, and lowers total cost of ownership through multi-tenant Software-as-a-Service (SaaS) architecture.

Headquartered in the United States, ArisGlobal has regional offices in Europe, India, Japan and China. For more updates, follow ArisGlobal on LinkedIn and Twitter.

The post ArisGlobal Will Showcase New Automation Solutions and Strategies to Industry Leaders at 2019 Life Sciences Technology Summit appeared first on ArisGlobal.

MIAMI, FL. and TOKYO, JAPAN, SEPTEMBER 18, 2019 – Santen Pharmaceutical Co., Ltd., the leader in ophthalmic drug development, has selected ArisGlobal to create a single global safety database and improve the efficiency and quality of their global safety vigilance processes. Santen Pharmaceutical’s safety suite will include ArisGlobal’s LifeSphere® MultiVigilance (LSMV), LifeSphere® Reporting and Analytics and LifeSphere® Intake and Triage solutions to automate key safety vigilance activities, reduce costs, and increase compliance.

“LSMV’s advanced artificial intelligence (AI) and machine learning automates repetitive manual tasks, improving efficiency and compliance levels. Switching to LSMV makes our team dramatically more efficient”, added Dr. Shimada, head of global safety vigilance at Santen Pharmaceutical.

Santen joins more than 250 life science companies, including 9 regulatory authorities, who use ArisGlobal’s safety, medical affairs, clinical and regulatory solutions, benefiting from rapid implementation on a multi-tenant cloud with upgrades delivered seamlessly.

“We are very pleased that Santen Pharmaceutical will adopt ArisGlobal’s multi-tenant LifeSphere® Safety suite,” said Sankesh Abbhi, ArisGlobal’s President and CEO. “We offer the world’s largest and most innovative multi-tenant safety cloud and Santen is an example of how customers in Japan and globally can meet a wide range of requirements for patient safety by leveraging our leading technology.”

In addition, Santen will adopt ArisGlobal’s rapid migration methodology, which has been successfully embraced by many of the world’s leading life sciences companies when transitioning from their legacy safety systems. “Our tested and repeatable methodology has proven highly effective as we become the preferred safety cloud solution for major pharma,” added Abbhi. “We’re able to drastically reduce the traditional challenges of data migration, change management and user training, reducing transition risk and bringing necessary peace of mind.”

About ArisGlobal

Headquartered in the United States, ArisGlobal has regional offices in Europe, India and Japan. For more information, visit arisglobal.com or follow ArisGlobal on LinkedIn and Twitter.

About Santen Pharmaceutical

As a specialized company dedicated to ophthalmology, Santen carries out research, development, marketing, and sales of pharmaceuticals, over-the-counter products, and medical devices. Santen is the market leader for prescription ophthalmic pharmaceuticals in Japan and its products now reach patients in over 60 countries. With scientific knowledge and organizational capabilities nurtured over a nearly 130-year history, Santen provides products and services to contribute to the well-being of patients, their loved ones and consequently to society. For more information, please visit Santen’s website (www.santen.com).

The post Santen Pharmaceutical establishes a safety database with ArisGlobal’s LifeSphere® MultiVigilance multi-tenant drug safety suite to improve and streamline pharmacovigilance at a global scale appeared first on ArisGlobal.

LifeSphere® MultiVigilance 10 features all new architecture and design, incorporating the latest cognitive automation technology to deliver groundbreaking efficiency gains to PV teams

MIAMI, FL OCTOBER 2, 2019 – ArisGlobal, the visionary provider of drug development technology for the life sciences industry, today announced the availability of LifeSphere^® MultiVigilance 10 (LSMV10), the industry’s only end-to-end drug safety system with production-ready automation. LSMV10 has been developed and tested in partnership with leading global pharmaceutical companies and health authorities, resulting in a solution that provides immediate efficiency gains and out-of-the-box compliance with all global submission requirements.

Under tightening budgets and evolving global regulations, safety case volumes continue to grow by nearly 15% each year, creating challenges for today’s drug safety teams. To address these pressures, LSMV10 leverages cognitive computing technologies such as natural language processing and machine learning, providing a single, global database that supports end-to-end automation of all adverse event processing. In addition, LSMV10 is part of ArisGlobal’s unified LifeSphere^® Platform and is the first and only safety system to offer out-of-the-box integration with medical information and product complaint solutions, enabling the seamless exchange of safety data between these critical functions.

“Since we launched LifeSphere’s initial AI capabilities in June 2018, we’ve been fortunate to work with an incredible group of industry-leading early adopters who have helped us make significant advancements in PV automation” said Aman Wasan, Vice President of Global Pharmacovigilance at ArisGlobal. “The result is production-ready automation in LSMV10, extensively tested and used by the world’s leading regulatory agency and several large life sciences organizations, including two of the top 25 pharma. This group worked with us to identify automation opportunities within case processing and assisted in developing innovative ways to solve them. This has resulted in significant efficiency gains and the potential for sizable cost savings.”

The foundation of ArisGlobal’s all new LifeSphere Safety platform, LifeSphere MultiVigilance 10 has been built from the ground up on brand new cloud architecture, powered by Amazon Web Services. Seamless upgrades delivered over the cloud ensure that LSMV10 is always “future proofed” and compliant, and customers no longer need to manage expensive and resource-intensive on-premise solutions.

Learn more: For more on LifeSphere^® Multivigilance 10, visit: https://bit.ly/2lyYbyW

About ArisGlobal

ArisGlobal is a visionary technology company that’s transforming the way today’s most successful life sciences companies develop breakthroughs and bring new products to market. The ArisGlobal LifeSphere^® cognitive technology platform integrates machine-learning capabilities to automate the core functions of the product lifecycle. Designed with deep expertise and a long-term perspective that spans more than 30 years, our cognitive platform delivers actionable insights, boosts efficiency, ensures compliance, and lowers total cost of ownership through multi-tenancy.

Headquartered in the United States, ArisGlobal has regional offices in Europe, India, Japan and China. Visit arisglobal.com or follow ArisGlobal on LinkedIn and Twitter.

The post ArisGlobal Announces LifeSphere® MultiVigilance 10, Industry’s First End-to-End Safety System with Production-Ready Automation appeared first on ArisGlobal.

LifeSphere^® LitPro helps medical information managers comply with literature monitoring requirements with increased speed and greater accuracy

MIAMI, FL OCTOBER 2, 2019 – ArisGlobal, the visionary technology provider of automated solutions for the life sciences industry, today announced the availability of LifeSphere^® LitPro (LSLP), the life science industry’s first and only solution that effectively automates all steps in the medical literature monitoring (MLM) process required by most regulatory agencies. From literature monitoring through to triage of any discovered adverse events, LSLP goes beyond the capabilities of any other MLM solution in the life sciences industry. Because the solution is system-agnostic, it can be utilized either as part of ArisGlobal’s LifeSphere Safety cognitive platform, or separately with out-of-the-box integration with other safety database systems and products, such as a company’s current literature search tool.

“LifeSphere^® LitPro has been designed to give marketing authorization holders an automated, effective and efficient solution to better meet regulatory requirements and strengthen overall pharmacovigilance,” said Dr. Aman Wasan, Vice President, Global Pharmacovigilance and Global Client Partners Group. “It is completely configurable to address changes in literature monitoring and search requirements, giving companies assured compliance and future preparedness.”

Based on search criteria given, LSLP identifies and retrieves all relevant literature from literature repositories such as Embase, MEDLINE, PubMed, HubMed, and others. It then performs a duplicate check of abstracts to identify unique/new relevant abstracts, scans that literature, and conducts a review and assessment using natural language processing to determine if a relationship exists between an event and a medicinal product. Upon finding any relationship, all key data is automatically extracted and sent downstream, where a new case is automatically created based on analysis of the search, and then triaged within the marketing authorization holder’s safety system of choice.

Throughout this process, LSLP progresses with continuous machine learning so that any initial manual intervention, such as user review and adjustments to add content, will dissipate over time to give organizations even greater decreased manual intervention and timely discovery of adverse events.

LSLP is a multi-tenant cloud solution powered by Amazon Web Services (AWS), an ArisGlobal partner. Customers no longer need any server or on-premise infrastructure to support and maintain.

Learn more: For more on LSLP, visit: https://bit.ly/2mNs1R3

About ArisGlobal

ArisGlobal is a visionary technology company that’s transforming the way today’s most successful life sciences companies develop breakthroughs and bring new products to market. The ArisGlobal LifeSphere^® cognitive technology platform integrates machine-learning capabilities to automate the core functions of the product lifecycle. Designed with deep expertise and a long-term perspective that spans more than 30 years, our cognitive platform delivers actionable insights, boosts efficiency, ensures compliance, and lowers total cost of ownership through multi-tenancy.

Headquartered in the United States, ArisGlobal has regional offices in Europe, India, Japan and China. Visit arisglobal.com or follow ArisGlobal on LinkedIn and Twitter.

The post ArisGlobal Releases Comprehensive Automated Literature Monitoring Solution for Improved Pharmacovigilance appeared first on ArisGlobal.

MIAMI, FL NOVEMBER 12, 2019 – ArisGlobal, the visionary technology provider of automated solutions for the life sciences industry, is proud to announce that ten life sciences companies have switched to its industry-leading LifeSphere^® MultiVigilance 10 drug safety system within the past 12 months. LifeSphere MultiVigilance is a next-generation, end-to-end safety system that has been developed in close partnership with industry leaders, including the FDA, Boehringer Ingelheim, Teva and AbbVie, among others. The announcement of 10 new customers switching from their incumbent safety system vendors to LifeSphere MultiVigilance is representative of the strong momentum ArisGlobal has generated, thanks to a record year in 2018 and continued growth in 2019.

ArisGlobal’s focus on reducing the pains associated with switching to a new safety system has enabled the company’s success, as investments in technology and professional services expertise have paid dividends in streamlining data migrations, standardizing implementations and scaling organizational change management. Through its productized solutions like the Organizational Readiness offering, ArisGlobal has demonstrated the ability to reduce the risk associated with switching from legacy technology to LifeSphere’s proven multi-tenant cloud platform.

“We are incredibly excited to welcome our new customers to the ArisGlobal family,” said Sankesh Abbhi, President and CEO of ArisGlobal. “That we’ve seen such success migrating new customers to our platform shows the market is responding well to the innovations we’re deploying in our LifeSphere MultiVigilance safety system. We understand that many customers on legacy technology from the larger incumbents are now looking for automation, an enhanced user experience and cloud technology that makes upgrades painless. We’re encouraged by the response that we’ve seen.”

ArisGlobal’s LifeSphere MultiVigilance 10 is the industry’s only next-generation safety system with production-ready automation and is the chosen safety database of the FDA.

Learn more:

For more on LifeSphere MultiVigilance 10, visit: https://www.arisglobal.com/products/lsmv10/

About ArisGlobal

ArisGlobal is transforming the way today’s most successful Life Sciences companies develop breakthroughs and bring new products to market. Our end-to-end drug development technology platform, LifeSphere^®, integrates our proprietary Nava^® cognitive computing engine to automate all core functions of the drug development lifecycle. Designed with deep expertise and a long-term perspective that spans more than 30 years, LifeSphere^® is a unified platform that boosts efficiency, ensures compliance, delivers actionable insights, and lowers total cost of ownership through multi-tenant SaaS architecture.

Headquartered in the United States, ArisGlobal has regional offices in Europe, India, Japan and China. For more updates, follow ArisGlobal on LinkedIn and Twitter.

The post 10 Life Sciences Companies Switch to ArisGlobal’s LifeSphere® MultiVigilance from Competing Safety Systems appeared first on ArisGlobal.

On Oct 15th, 2019, ArisGlobal held a webinar titled “Automation in Pharmacovigilance: From Hype to Reality.“ The webinar was presented by Aman Wasan, Vice President, Global Pharmacovigilance for ArisGlobal, and focused on separating the hype around automation in pharmacovigilance (PV) from practical reality.

During the webinar, Aman addressed the challenges that today’s pharmacovigilance executives face when it comes to managing case intake processes and procedures. These challenges include growing volumes, dynamically expanding global regulations, and diversity in data sources. Aman also examined how these factors are putting pressure on life sciences companies to explore technological advancements and leverage AI/automation to manage their pharmacovigilance.

At the beginning of the webinar, Aman asked attendees if they plan to use automation to combat their PV-related management challenges. Forty three percent (43%) of respondents indicated that proper PV automation is one of their highest priorities. However, an additional 36% indicated no plans for automation, either because they don’t know enough about how to embrace it, or its just simply not on their radar screen. Why such a disparity?

Poll: Does your Company Have a Strategic Plan for PV Automation?

Yes, Automation of PV Process is one of our highest priorities 43% 43%
No, because we don’t know much about automation 23% 23%
Yes. However, automation is not a high priority for us right now 21% 21%
No, because we don’t think automation is a priority right now 13% 13%

ArisGlobal believes that, while many organizations recognize the potential benefits that automation can bring to managing pharmacovigilance, there are still a lot of automation-related concerns that must be addressed before it is widely embraced within the life sciences industry. These include expectations management, the potential scope of automation within PV, how to begin the process, and the ability to support automation with existing systems and budget.

ArisGlobal, a pioneer in offering cloud-based solutions to the Life Sciences industry, has been a leader and innovator in Pharmacovigilance and Drug Safety software for over 30 years. Based on this experience, we understand the challenges associated with automating pharmacovigilance. ArisGlobal has built out-of-the-box workflows to optimize and automate key case processing steps, including case intake and triage, data entry and coding, case assessment and validation, quality review and follow-ups.

ArisGlobal recently launched an all-new, state-of-the-art safety system: LifeSphere MultiVigilance 10 (LSMV10). LSMV10 supports end-to-end integration and automation of adverse event management and has been built in collaboration with leading Life Sciences companies and top global regulatory authorities. It incorporates the latest in automation and cognitive computing technologies, including natural language processing (NLP) and machine learning.

To learn more about LSMV10 check out the video on LSMV10, here or read the factsheet, here.

In our next blog, we will discuss what is available today to automate the PV process. If you are curious, you can view the on-demand webinar for complete insights and discussion, here.

(This is Blog #1 in a series of 3 from Automation in Pharmacovigilance: From Hype to Reality webinar.)

Request a Demo

The post ArisGlobal Differentiates Automation Hype from Reality in Pharmacovigilance for the Life Sciences Industry appeared first on ArisGlobal.

The Implementation, Delivered On-Time via ArisGlobal’s Services Team, Enables the Top 5 Pharma to Process 1 Million Adverse Event Cases Annually

MIAMI, FL DECEMBER 10, 2019 – ArisGlobal, the visionary provider of drug development technology for the life sciences industry, today announced that it has successfully delivered the industry’s largest drug safety system implementation, going live on-time with its next-generation LifeSphere® MultiVigilance offering. The implementation, handled by ArisGlobal’s in-house Services team, required the migration of 6.8 million legacy cases, the training of more than 2,300 end users and tight coordination with the customer, a top 5 global pharma that was experiencing issues with its legacy drug safety technology systems.

To handle such a large-scale implementation, ArisGlobal made use of its Organizational Readiness offering, a solution that provides scalable change management, end user training and managed services, to ensure a smooth transition for the customer. The customer, having vetted other industry offerings during an extensive RFP process, ultimately selected ArisGlobal thanks to its innovative cloud technology, flexible out-of-the-box configuration codeveloped with industry leaders, and proven ability to deliver a large scale implementation that will ultimately process more than 1 million adverse event cases per year. After a successful go-live, the relationship is now growing to include other offerings in ArisGlobal’s LifeSphere solution portfolio.

“To deliver an end-to-end drug safety system to more than 2,300 end users is no easy feat,” said Ashok Katti, ArisGlobal’s COO & President, APAC. “But to go-live on time, having deployed a full-scale training and change management program, with no critical issues, is truly a testament to the strong relationship that we have built with the customer. We’re grateful for their partnership and look forward to a bright future together.

ArisGlobal’s LifeSphere MultiVigilance 10 is the industry’s only end-to-end safety system offering production-ready automation. Built hand in hand with industry leaders like the FDA and featuring brand new architecture and an intuitive design, LifeSphere MultiVigilance 10 represents a new era in drug safety technology.

Learn more: For more on LifeSphere MultiVigilance 10, visit: https://www.arisglobal.com/products/lsmv10/

About ArisGlobal

Headquartered in the United States, ArisGlobal has regional offices in Europe, India, Japan and China. For more updates, follow ArisGlobal on LinkedIn and Twitter.

The post ArisGlobal’s LifeSphere MultiVigilance Goes Live with Top 5 Pharma, Delivering a Next-Generation Safety System to 2,300+ End Users appeared first on ArisGlobal.

On Oct 15^th, 2019, ArisGlobal hosted a webinar titled “Automation in Pharmacovigilance: From Hype to Reality”. During the webinar, nearly half (43%) of attendees indicated that automation of pharmacovigilance (PV) processes is a top priority for their organizations. However, the areas of focus for this automation differed greatly. To this end, ArisGlobal believes that there is no single “right place to start” when it comes to automation, and life sciences organizations must instead choose their own adventure when it comes to a sound PV-focused automation strategy.

According to life sciences industry executives who attended ArisGlobal’s recent webinar, automation of PV-related practices can take many forms. Thirty nine percent (39%) of respondents felt that end-to-end case processing automation is the proper area to automate. Conversely, an additional 24% of attendees indicated that case intake processes were the right place to focus their automation efforts. Finally, duplicate check management was also a key area to automate, according to 20% of respondents.

Poll: Which Areas of PV you are Most Likely to Automate?

End-to-end to case processing 39% 39%
Case intake 24% 24%
Duplicate check 20% 20%
Narrative generation 11% 11%
Quality check 4% 4%
Follow-up processing 2% 2%

ArisGlobal has recently launched LifeSphere MultiVigilance 10 (LSMV10), a next-generation drug safety system with production-ready automation that has been tried and tested by major Life Sciences companies and a leading global authority. In fact, LSMV10 is the chosen safety system of the US Food and Drug Administration (FDA), thanks to its production-ready automation. LSMV10’s automation capabilities have been implemented by early adopters who have embraced the solution to automate data extraction, duplicate checks, validation, triage, and coding. The system can make intelligent assessment of cases and determine the validity.

LSMV10 is also enabled with advanced Natural Language Processing (NLP) to process unstructured data, complete automated follow-up management and automate language translations. The system allows for touchless case processing, with minimal human intervention, or a hybrid combination if one would want human intervention at certain points.

To explore LSMV10 please visit our website, here.

To learn about FDA adopting PV automation through LifeSphere MultiVigilance click here.

In our next blog, we will discuss a real case study of automation implementation and how PV processes are streamlined with LifeSphere MultiVigilance.If you are curious, view the on-demand webinar for complete insights and discussion, here

(This is Blog #2 in a series of 3 from Automation in Pharmacovigilance: From Hype to Reality webinar.)

Request a Demo

The post Automation in Pharmacovigilance – Choose Your Own Adventure. appeared first on ArisGlobal.

On Oct 15^th, 2019, ArisGlobal hosted a webinar titled “Automation in Pharmacovigilance: From Hype to Reality”. The webinar was hosted by Aman Wasan, Vice President, Global Pharmacovigilance for ArisGlobal. As a part the webinar, attendees shared their top concerns around implementing automation. Top responses included cost, replacing human decision-making, scepticism on quality, worry over risk, preparedness to accept change or simply not knowing the actual benefits of automation.

According to a recent ArisGlobal poll, nineteen percent (19%) are worried about automation cost. Seventeen percent (17%) mentioned the replacement of human decision-making was a major concern. An additional 15% are focused on quality concerns.

Poll: What concerns, if any, do you have when it comes to automating PV processes?

Cost associated with change 19% 19%
Hesitancy to replace human decision-making 17% 17%
Quality might suffer 15% 15%
Organizational readiness to adopt this type of change 14% 14%
Case volumes don’t justify the investment 12% 12%
Lack of internal expertise 10% 10%
Risk of change/perceived adverse impact to existing processes 8% 8%
Unsure of the actual benefits of automation 3% 3%
I don’t have any concerns about this 2% 2%

To address these concerns, Aman Wasan provided a real-world case study for implementing automation in pharmacovigilance using LifeSphere MultiVigilance 10 (LSMV10). LSMV10 is ArisGlobal’s next-generation drug safety platform with product-ready automation. The application discussion was centred around a leading global pharma who was an early adopter of LSMV10.

In this case study, the early adopter had multiple time-consuming manual activities for data reporting, capture, review and submission that resulted in low throughput, human error and compliance issues. Thanks to the adoption of automation through LSMV10, the customer was able to automate data extraction, review and reporting, ensuring accurate and consistent data capture and providing considerable savings. This example saw an efficiency gain of 35-40% in their case management process. As they expand automation capabilities, ArisGlobal’s time-motion studies suggest that efficiency gains of 50-55% can be achieved.

To learn more about the insights shared and questions answered, view on-demand webinar Automation in Pharmacovigilance: From Hype to Reality and to explore use cases, view on-demand webinar Key Use Cases of Automation in Pharmacovigilance held in June, 2019.

Read our whitepaper “Cognitive Computing in Pharmacovigilance: Revamping Drug Safety Using an Advanced Computing System”.

(This is Blog #3 in a series of 3 from Automation in Pharmacovigilance: From Hype to Reality webinar.)

Request a Demo

The post Automation in Pharmacovigilance: A Real-World Implementation Story appeared first on ArisGlobal.

MIAMI, FL January 27, 2020 – ArisGlobal, the leading provider of life sciences software that automates core drug development functions for over 250 life sciences companies, has expanded its partnership with Soterius, Inc., adding LifeSphere^® MultiVigilance and LifeSphere^® Medical Information to their service-oriented technology stack. The LifeSphere^® platform will deliver industry-leading technology-enabled services to Soterius’ expanding client base, comprised of leading global life sciences companies.

Soterius, a global leader in providing drug safety and medical outsourcing services and solutions, helps life sciences organizations take advantage of digital innovations that drive improved compliance and greater cost efficiencies.

“We are excited to expand our partnership with ArisGlobal and are delighted about the opportunities this alliance presents to our global customers,” said Suneet Walia, CEO of Soterius. “The implementation of ArisGlobal’s LifeSphere platform, combined with our integrated outsourced safety services will help our customers more efficiently address their global safety requirements. Furthermore, the synergies between our two companies will help our customers achieve cost effective rapid deployment, and long-term access to cutting-edge solutions and services.”

“We’re happy to see Soterius deploy LifeSphere MultiVigilance, the industry’s only end-to-end safety system offering production-ready automation built in partnership with industry leaders like the FDA, to grow their drug safety and pharmacovigilance solutions on a global scale,” said Aman Wasan, Vice President, Global Client Partners at ArisGlobal. “The expansion of our partnership to include LifeSphere Medical Information, our industry-leading medical information solution, represents yet another of our top partners embracing our platform-first approach to drug development technology,” added Mr. Wasan.

Learn more: For more on LifeSphere MultiVigilance 10, visit: https://www.arisglobal.com/products/lsmv10/

About ArisGlobal

Headquartered in the United States, ArisGlobal has regional offices in Europe, India, Japan and China. For more updates, follow ArisGlobal on LinkedIn and Twitter.

About Soterius

Soterius is the global industry leader in providing comprehensive drug safety and medical affairs services, supporting customers with the industry’s first platform to enable pharma companies and regulators worldwide to collaborate and share data. Soterius is a thriving customer-focused organization, with proven commitment to finding solutions for the people it serves, to driving excellence in compliance, and to improving patient outcomes. Soterius has its headquarters in Princeton, NJ, and has offices in North America, Europe, and Asia. For more updates, follow Soterius on Facebook, Twitter and LinkedIn.

The post ArisGlobal and Soterius Extend Partnership with Global Delivery of LifeSphere® MultiVigilance and LifeSphere® Medical Information appeared first on ArisGlobal.

MIAMI, FL Febuary 3, 2020 – ArisGlobal, the leading provider of life sciences software that automates core drug development functions for over 250 global life sciences companies, today announced it has made a number of new key leadership hires, with the express purpose of preparing for accelerated growth in North America, Europe, and Asia, and new product launches in 2020, according to President and CEO Sankesh Abbhi.

“As we increase our market share and expand to new regions, the additions to the leadership team will help us execute our strategy and further drive our growth,” said Mr. Abbhi. “The new executives joining the team bring decades of industry expertise and will be instrumental in advancing our mission to digitally transform drug development through simple, intelligent and unified technology.”

Among the key hires announced:

Clint Wolfe, a 20-year tenured industry veteran, joins as Chief Human Resources Officer to lead ArisGlobal’s global HR team and strategy.
Andras Berta, a former executive at Gedeon Richter and Vifor Pharma, joins as Chief Strategy Officer to head ArisGlobal’s product strategy.
Rick Simpson, a former finance executive at SaaS and healthcare companies, joins ArisGlobal as Chief Financial Officer to oversee ArisGlobal’s financial strategy and team.

“I’m immediately impressed by the level of expert talent we’ve been able to attract and retain as a company, as we build cutting-edge technology to help our customers bring drugs to market faster and more safely,” said Clint Wolfe, CHRO of ArisGlobal. “I’m very excited to join ArisGlobal in this important moment. As the company continues its positive trajectory, having a global team working together is increasingly more important for us as an organization,” added Mr. Wolfe.

The company recently completed hiring other key leadership roles in cloud infrastructure, customer support, user experience, drug safety, clinical development, regulatory affairs, and medical affairs, to further advance its LifeSphere drug development platform.

About ArisGlobal

Headquartered in the United States, ArisGlobal has regional offices in Europe, India, Japan and China. For more updates, follow ArisGlobal on LinkedIn and Twitter.

The post ArisGlobal Hires Key Executives as it Prepares for Accelerated Growth and New Product Launches appeared first on ArisGlobal.

SUMMARY

A large multinational medical device and health care organization was looking for a way to bring automation and a higher degree of control to their existing Medical Literature Monitoring (MLM) processes. They were also looking for tighter integration with their Pharmacovigilance (PV) IT systems already in place. Observing this need, not only for this organization but for other global life sciences companies, ArisGlobal and the medical device and healthcare organization partnered to build an innovative product to address these challenges. This began the development of LifeSphere^® LitPro, a full-service automated literature screening and monitoring solution designed to help life sciences organizations meet regulatory compliance requirements by scanning global and local literature databases for safety-relevant information including products, adverse events, medical terms, and investigations.

KEY CHALLENGES

Before working with ArisGlobal, the medical device and healthcare organization identified specific key challenges related to its existing MDM processes that required adjustment. For example, even though their current tool enabled automated literature search externally, the organization was forced to enter cases into its existing safety system manually. Additionally, its existing application did not provide a comprehensive receipt repository. Finally, with their existing MLM system, reports could not be generated outside of the system to maintain an overview of the application and workload. The overall consensus was that the identification of safety-relevant alerts was a manual and time-consuming process, with no flexibility for customization. The result was inefficient literature searches and processing techniques.

The medical device and healthcare organization began searching for an alternative. Though there are a handful of literature review solutions in the market, none of them properly addressed pre-defined needs. Some systems, for example, were not compatible with their current safety IT platform. Others proved to be too tedious to use. Most systems necessitated manual case data entry, while also requiring data to be entered numerous times.

STRATEGY AND SOLUTION

Based on the medical device and healthcare organization’s long-term relationship with ArisGlobal, spanning more than 15 years across the Safety, Regulatory, Clinical and Medical Affairs domains, they agreed to collaborate in developing the life sciences industry’s first and only solution to effectively automate all steps in the medical literature monitoring process. The solution was designed to complement and integrate with the medical device and healthcare organization’s existing MDM solutions, not replace them. And, because LifeSphere® LitPro is a cloud solution, all future upgrades and new features will be delivered seamlessly via the cloud.

Throughout the development of LitPro, users have been testing the product and providing valuable feedback. This data has been collected in an online tracking portal and utilized to identify new requirements and enhancements, allowing all LitPro customers to benefit from a truly collaborative approach. ArisGlobal is also engaged with other leading pharmaceutical organizations to deploy solutions to automate their MLM processes.

ArisGlobal’s LifeSphere LitPro application is a full-service automated literature screening and monitoring solution designed to help life sciences organizations meet regulatory compliance requirements by scanning global and local literature databases for safety-relevant information including products, adverse events, medical terms, and investigations. It automates the process of:

Identifying and retrieving all relevant journal article details from bibliographic databases.
Scanning the selected information sources for relevant safety information and applying basic attribution rules to determine if there is a relationship between an event(s) and medicinal product(s).

LifeSphere LitPro boosts efficiency, ensures compliance, delivers actionable insights, and lowers the total cost of ownership through multi-tenant architecture.

CONCLUSION

Due to the success of the LifeSphere LitPro collaboration between ArisGlobal and the medical device and healthcare organization, a significant number of current prospects have shortlisted LifeSphere LitPro in their selection process for a solution to meet literature review needs. ArisGlobal will continue to collaborate with clients in their efforts to provide the best products and tools in the Life Sciences industry.

The post Multinational Medical Device and Healthcare Organization Embraces LifeSphere® LitPro to Automate Literature Search and Monitoring appeared first on ArisGlobal.

MIAMI, FL January 22, 2020 – Linical, a market-leading, midsized, global contract research organization (CRO), announced they have adopted ArisGlobal as their primary global safety management system. ArisGlobal’s LifeSphere^® MultiVigilance is a next-generation platform for clinical and commercial product safety management, including intelligent, machine-learning enhanced adverse event case processing. This platform will be a key component of Linical’s pharmacovigilance services, enhancing efficiency, ensuring compliance, and helping reduce the cost of safety data processing.

The FDA implemented ArisGlobal’s LifeSphere^® MultiVigilance as their integrated safety platform in 2018, helping establish the system as the gold standard in pharmacovigilance, including intake, triage and processing of safety reports. Linical has also successfully adopted the platform across their organization’s locations to support clients’ pharmacovigilance needs worldwide. Through modeling LifeSphere^® within their organization, Linical can provide pharmacovigilance services to clients of all sizes, ranging from more customized safety processing services to higher volume, more automated data sets. Linical combines their pharmacovigilance team’s therapeutic expertise with LifeSphere^® MultiVigilance’s native artificial intelligence (AI) and robotic process automation (RPA) to offer clients a powerful solution increasing compliance, reducing time to market, and controlling drug development costs.

“Using ArisGlobal is part of our commitment to working with cutting edge systems. Not only will this provide benefits to our clients, but this will also help in our commitment to ensuring long term patient safety and corporate regulatory compliance.” said Tracy Goeken, MD, Chief Medical Officer of Linical.

“ArisGlobal is excited the largest publicly traded Japanese CRO has selected our services as their primary safety database.” said Aman Wasan, Vice President of Global Client Partners at ArisGlobal. “LifeSphere^® MultiVigilance has been built hand-in-hand with top global life sciences organizations and is the first safety system offering production-ready automation. We appreciate our strong partnership with Linical and their commitment to bringing next-generation drug development technology to their customers,” added Mr. Wasan.

About ArisGlobal

Headquartered in the United States, ArisGlobal has regional offices in Europe, India, Japan and China. For more updates, follow ArisGlobal on LinkedIn and Twitter.

About Linical

Linical is a market-leading, public, midsized CRO with a significant footprint across North America, Europe and Asia-Pacific. With operations in more than 20 countries, Linical is a global, full-service drug development partner, uniquely capable of conducting large-scale, multinational studies, while delivering personalized, hands-on service. Our areas of expertise include Phase I-IV oncology, hematology, vaccine, CNS and general medicine trials. We leverage regulatory consulting services, operational knowledge and patient recruitment/retention strategies to support clients in successful clinical trials.

The post Linical Adopts ArisGlobal as Primary Global Safety Management System appeared first on ArisGlobal.

A multinational tobacco products manufacturing company recently selected ArisGlobal’s LifeSphere® MultiVigilance 10 for their global safety vigilance needs. 

MIAMI, FL Febuary 11, 2020 – ArisGlobal, the leading provider of life sciences software that automates core drug development functions for over 250 life sciences companies, today announced one of the world’s largest tobacco manufacturing companies has selected LifeSphere^® MultiVigilance 10 (LSMV10) as its global safety vigilance system. The company’s main objective is to internalize safety vigilance, which was previously managed by a third party CRO, to achieve maximum cost-effectiveness through end-to-end automation.

LifeSphere^® MultiVigilance 10 is the industry’s first and only adverse event platform to seamlessly integrate product quality complaint and medical information systems into a single, integrated platform, thus enabling the exchange of safety cases between these critical functions.

“We are very pleased to have this global organization adopt ArisGlobal’s multi-tenant LifeSphere^® MultiVigilance 10,” said Sankesh Abbhi, ArisGlobal’s President and CEO. “We offer the world’s largest and most innovative multi-tenant safety cloud. This tobacco company is an example of how customers can manage adverse events on an end-to-end basis by leveraging our leading technology. LSMV10 is production-ready, has been extensively tested, and is currently being used by a major regulatory agency in the United States. It is also being utilized by several leading pharma companies who worked with us to identify business-critical problems within case processing and then assisted us in finding innovative ways to solve them.”

Learn more: For more on LifeSphere^® Multivigilance 10,

visit: https://www.arisglobal.com/products/LSMV10/

About ArisGlobal

Headquartered in the United States, ArisGlobal has regional offices in Europe, India, Japan and China. For more updates, follow ArisGlobal on LinkedIn and Twitter.

The post Major Tobacco Manufacturer Selects LifeSphere® MultiVigilance to Automate All Global Internal Adverse Event Management Processes appeared first on ArisGlobal.

Related Blogs

What is your top percieved challenge when it comes to managing your medical affairs content?

Have you adopted component authoring for standard response documents?

Related Blogs

Industry Trends: Moving from Documents to Data

Improving Data Quality

Related Blogs

Alignment Between Data and Documents

Using Regulatory Data to Benefit Your Organization

Related Blogs

Related Blogs

Do you currently provide self-service content to HCPs and Sales representatives/MSLs?

Which areas of PV are you most likely to automate?

Recent Posts

White Papers

Webcast

Need More Information?

Need More Information?

Does your organization have any initiatives related to Structured Content authoring?

Does your organization have any Master Data Management initiative related to standardization of terminology?

What is the main motivation for your organization to consider a solution for structured authoring?

Related Blogs

Request a Demo

Recent Press Releases

Recent Press Releases

About Santen Pharmaceutical

Recent Press Releases

Recent Press Releases

Recent Press Releases

Recent Press Releases

Related Blogs

Request a Demo

Recent Press Releases

Related Blogs

Request a Demo

Related Blogs

Request a Demo

About ArisGlobal

About Soterius

Recent Press Releases

About ArisGlobal

Recent Press Releases

SUMMARY

KEY CHALLENGES

STRATEGY AND SOLUTION

CONCLUSION

About ArisGlobal

About Linical

Recent Press Releases

About ArisGlobal

Recent Press Releases