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INFOGRAPHIC: “The Future of Regulatory Information Management”


Convergence of Local & Global Pharmacovigilance Regulations in China for Drug Manufacturers

The Future of Regulatory Affairs

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Wim Cypers, Senior Vice President-Regulatory at ArisGlobal to Co-Instruct DIA’s RSIDM Forum Pre-Conference Short Course 2

MIAMI, FL. JANUARY 17, 2019 – ArisGlobal, a leading provider of integrated, multi-tenant cloud-based software solutions for life sciences, announced that Wim Cypers, Senior Vice President – Regulatory at ArisGlobal and industry expert, will co-instruct a pre-conference short course on “The Future of Regulatory Affairs” with Michiel Stam, Regulatory Information Scientist, eCTDconsultancy B.V. at the DIA Regulatory Submissions, information and Document Management Forum (RSIDM), scheduled for February 11,2019 at the Bethesda North Marriott Hotel and Conference Center in North Bethesda, Maryland.

“Poor real-time visibility into the authorized status of submissions, the need for greater affiliate participation, and the pressure for greater forecasting are just some of the challenges that need alignment of RA strategy, people, processes and data with the rest of the organization,” said Wim. “This DIA short course will share real-life, best-practices examples from various pharma companies to show how the transformation happening now within regulatory affairs will lead to well-defined end-to-end business processes that help address these challenges.”

ArisGlobal will also be exhibiting at RSIDM in booth #300, showcasing LifeSphere Regulatory.

Learn more on the short course:  https://goo.gl/xFUeMr

Learn more: LifeSphere Regulatory  https://goo.gl/XBfiMU

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. For more information, visit arisglobal.com or follow ArisGlobal on LinkedIn and Twitter.

The post The Future of Regulatory Affairs appeared first on ArisGlobal.

From Good to Great: The Benefits of a Unified Clinical and Regulatory Data Management Strategy

ISP Workshop 15

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ISP Workshop 15 Registration

Venue: Copenhagen, Denmark

Date: 6 May 2019 to 8 May 2019

Please fill in the below information to register:

The post ISP Workshop 15 appeared first on ArisGlobal.

Creating a Unified Clinical and Regulatory Data Management Strategy

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“In the increasingly complex environments of product development lifecycles, industry leaders are looking to streamline and transform their cross-functional business processes and strengthen their governance by creating common, strategic capabilities. Having these key unified capabilities between Clinical and Regulatory departments is key to exchanging critical information. That’s what this webinar will explore in more detail.”

ArisGlobal held a mid-January webcast From Good to Great: The Benefits of Unified Clinical and Regulatory Data Management Strategy with the goal of examining the challenges involved, benefits to be gained, requirements of unified regulatory and clinical business processes, and recommendations for taking the next steps forward. ArisGlobal presenters, Vitthal Gouri, Associate VP, Clinical Solutions, and Pratyusha Pallavi, Associate Director, Regulatory Product Management, shared their respective expertise to advance the viewpoint that it’s time to explore the significant gains to be achieved from this unification with the right approach, advanced platform, cross-department participation and commitment across clinical, regulatory and IT departments.

The webcast audience, comprising of strong representation across clinical, regulatory and IT, responded to polling questions that helped throw light on the current reality facing companies seeking to undertake the mammoth task of cross departmental unification.

Beginning with the polling question on “What has been your biggest challenge in relation to Clinical and Regulatory technologies?”, the attendee polling results across the five possible responses clearly showed that the regulatory and clinical departments are grappling with a multi-faceted challenge. The results showed nearly equal strength except for one. Laborious Upgrades and Validation Cycles ranked highest with 25%, but the lack of a Single Source of Truth, Complexity of Desired Process Automation, and Data Quality Not Available in Real-Time all tied at 21%. Trailing last at 13% was Lack of Common Terminology.

Integration Is Not the Same as Unification

After discussing the challenges, Vitthal delved into how today’s current architecture that is Web-based and involving loosely coupled integrations continues to present costly and complex issues that, at the end of the day, doesn’t represent what an effective drug development environment requires.

Presenting a clear end-to-end development process diagram and discussing the interwoven business processes of clinical and regulatory, Vitthal and Pratyusha shared how there is clearly a lot of back-and-forth between the two departments in terms of processes, data and documents, all of which requires a unified database. The need for a cognitive computing platform, a defined and shared library, repositories, inter-connected business processes and stakeholders is where unification can begin.

But where do most companies stand now in achieving a unified clinical and regulatory data management strategy?  The webcast’s final polling question showed some interesting findings:

More than half fall in the exploration-to-education stage, and yet only 13% have business leadership fully engaged in achieving a unified approach. Finally, not a single company has IT fully engaged, with implementation underway. Pratyusha explained that this is not a surprise given that Life Sciences is still at the start of the of digital maturity curve, unlike other industries. While Life Sciences has started to invest in exploring the use cases of unification between Clinical and Regulatory, project funding to initiate full scale implementation is much slower currently.

Intriguing questions from attendees on aspects like cross-department unification examples, disadvantages of unification, common data model responsibility, and recommended first steps were covered. We are confident that the information shared will likely lead to ongoing discussions within attending organizations. We encourage you to view the on-demand webcast for more details on what was shared. Have any questions? Send an email to info@arisglobal.com.

The post Creating a Unified Clinical and Regulatory Data Management Strategy appeared first on ArisGlobal.

The ‘Learning’ Pharmacovigilance System : From Concept to Reality

ArisGlobal Launches Enterprise-Level Document Management Platform

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LifeSphere® EasyDocs enables the life sciences industry to eliminate multiple siloed applications and reduce integration complexities while unifying document management

Miami, Florida – March7, 2019 – ArisGlobal, a leading provider of life sciences software that automates core drug development functions for over 200 global life sciences companies, today announced the release of LifeSphere® EasyDocs, an advanced cloud platform that streamlines enterprise document management across the product development lifecycle. Seamlessly woven into ArisGlobal’s LifeSphere® ecosystem, which includes the LifeSphere® Clinical, Regulatory, Safety and Medical Affairs platforms, life sciences organizations will now have a highly configurable, scalable solution that gives users a unified view of content and data across all domains. LifeSphere® EasyDocs significantly improves user productivity and operational efficiency, and delivers the critical ‘single source of truth’ for assured compliance across the end-to-end development lifecycle.

“Today’s life sciences company wants to achieve faster document approvals that meet both changing compliance requirements and global business needs for collaboration. An enterprise content management solution, unified across the end-to-end product development lifecycle, can make the difference by enabling improved communication, collaboration, visibility and process efficiency over data and content, and ultimately help achieve faster document approval,” said Sankesh Abbhi, President and CEO of ArisGlobal. “LifeSphere EasyDocs, using ArisGlobal’s platform-based approach, is highly configurable and designed to support various business processes and document types, while ensuring the flow of information across drug development functions. It offers the potential to replace disparate point solutions, lowering technology costs and increasing return on investment.”

LifeSphere EasyDocs offers the following capabilities as part of its unified platform for document and content management:

  • Advanced document management platform with highly configurable lifecycle and workflow management modules
  • Cross-domain ‘Single source of truth’ for all types of documents in drug development functions
  • An intuitive, easy-to-use and mobile-enabled user interface
  • Seamless integration with the entire LifeSphere® ecosystem that includes clinical, regulatory, safety and medical information
  • Open SOA architecture and highly interoperable API library, offering easy integration with third-party systems
  • Pre-validated deployment on the state-of-the-art Amazon Web Services (AWS) cloud

ArisGlobal is also announcing LifeSphere® Publishing, part of the LifeSphere® Regulatory platform, giving companies a cloud-based solution for compiling, publishing and validating regulatory submissions, with full support for all major global eCTD requirements.

Learn more: LifeSphere EasyDocs

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. 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® 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. Visit arisglobal.com, or follow ArisGlobal on LinkedIn and Twitter.

The post ArisGlobal Launches Enterprise-Level Document Management Platform appeared first on ArisGlobal.


ArisGlobal Launches LifeSphere Publishing as Key Component of LifeSphere Regulatory Cloud Platform

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Regulatory teams benefit from a streamlined, end-to-end publishing process

Miami, Florida – March7, 2019 – ArisGlobal, a leading provider of life sciences software that automates core drug development functions for over 200 life sciences companies, today announced LifeSphere® Publishing, a complete, pre-validated submissions management system that enables life science organizations to easily plan, compile, publish, and validate regulatory submissions with full support for all major global eCTD requirements. LifeSphere Publishing can be used as a standalone application or as an integral part of ArisGlobal’s LifeSphere® Regulatory end-to-end cloud platform for regulatory affairs.

As part of the LifeSphere cognitive platform, LifeSphere Publishing works seamlessly with LifeSphere® EasyDocs, also announced today, to provide a fully unified content and submission management solution. Built on open SOA architecture, the solution offers configurable APIs to enable easy integration with other document management systems such as Documentum, D2, SharePoint, and more.

“Many life sciences companies face an increasing volume of digital assets being created and managed across multiple repositories. This reality makes it extremely difficult to have true visibility into where approved content exists across the organization and potentially leads to compliance issues,” said Wim Cypers, Senior Vice President, Regulatory Affairs of ArisGlobal. “LifeSphere Publishing and LifeSphere EasyDocs, in combination with LifeSphere Regulatory, help users to manage, in a single unified platform, all content related challenges and ensures compliance for years to come.”

LifeSphere Publishing offers feature-rich capabilities that deliver powerful benefits:

  • Seamless integration with regulatory information management, document management, and dossier management systems gives companies comprehensive capabilities across the product regulatory lifecycle
  • An intuitive, easy-to-use and mobile-enabled user interface enhances the user’s experience for compiling, publishing and validating submissions
  • Built-in document management functionalities with lifecycle and workflow management proactively navigate users through assigned activities
  • eCTD submission lifecycle management and support for FDA application and submissions ensure compliance
  • Pre-validated deployment on the state-of-the-art Amazon Web Services (AWS) cloud eliminates internal infrastructure and need for costly upgrades

Learn more: LifeSphere Publishing

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. 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® 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. Visit arisglobal.com, or follow ArisGlobal on LinkedIn and Twitter.

The post ArisGlobal Launches LifeSphere Publishing as Key Component of LifeSphere Regulatory Cloud Platform appeared first on ArisGlobal.

“Towards Regulatory 2025” to Be Presented by ArisGlobal Regulatory Expert at eRegulatory Summit 2019

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MIAMI, FL. MARCH 12, 2019 – ArisGlobal, LLC, a leading provider of integrated cloud-based software solutions for life sciences, will present a session titled, “Towards Regulatory 2025 – The Building Blocks of the Future” at the upcoming eRegulatory Summit to be held in Barcelona, Spain from April 8-10, 2019.

Mallika Rajaesekaran, Director of Regulatory Product Management, ArisGlobal, will present the session, scheduled for April 9, 15:10-15:40 CST. Mallika will shed light on how the digital transformation has begun within Regulatory Affairs as innovators start implementing concrete building blocks of a comprehensive 2025 regulatory landscape.

“Today’s life sciences company needs to assess current and emerging technologies to determine what, when, and how to leverage capabilities to the benefit of their organization,” Mallika explained. “My session will focus on the emerging changes taking place in technology innovation spending, the paradigm shift from system integration to cross-department unification, regulatory automation use cases using structured authoring, and conclude with a systematic approach to regulatory intelligence.”

Mallika heads the regulatory product management in ArisGlobal, and is the key contributor in building LifeSphere® RIMS, the company’s next-generation Regulatory Information Management System.

ArisGlobal is a sponsor of this conference and will be exhibiting in booth #1. Attendees are welcome to visit and learn more about LifeSphere® Regulatory, the end-to-end regulatory platform that leverages industry-standard processes (ISPs) and cognitive computing capabilities to help effi­ciently integrate compliance with automated business processes over the entire product management lifecycle.

Interested attendees can register and use the discount code CQ5271ARIS to receive a 25% VIP discount.

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. For more information, visit arisglobal.com or follow ArisGlobal on LinkedIn and Twitter.

The post “Towards Regulatory 2025” to Be Presented by ArisGlobal Regulatory Expert at eRegulatory Summit 2019 appeared first on ArisGlobal.

AI, Cloud and Other Advanced Technology: Are You Ready for the New Era of Drug Safety?

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This is the first in a two-part blog series that examines the key areas that pharmaceutical companies, service providers and solution providers should focus on as technology advancements continue to transform drug safety for the better.

Together with advanced computing technologies like artificial intelligence in pharmacovigilance systems and processes, the life sciences industry as we currently know it is facing digital disruption that will create major transformation for the better…and more changes are on the horizon. These changes represent a disruptive shift to the traditional manner of processing data. In particular, Drug Safety/Pharmacovigilance is going through a paradigm shift, as technology developers are incorporating modern infrastructure, as well as robotic and cognitive automation capabilities, to redefine the end-to-end activities in safety case processing.

Pharmaceutical Companies & Service Providers: How well are you prepared for the change?

The huge potential to alleviate the impact of increasing adverse event case volumes is driving pharmaceutical companies to challenge internal processes to incorporate these technological advancements. For service providers (CROs/KPOs/BPOs), who are under constant pressure to deliver annual cost reductions, these technology advancements can be the holy grail to increasing productivity while reducing costs.  With all these moving parts, it is imperative that the overall industry-preparedness level, including those of regulators, be raised.

Below are some of the key areas that pharmacovigilance departments and service providers should focus on to achieve to ensure preparedness for this change:

  • Aim to minimize costs associated with current safety database infrastructure, including maintenance costs, by capitalizing on shifts to multi-tenant and SaaS models
  • Move away from highly customized processes and adopt industry-leading, highly efficient, standardized processes, eliminating the burden on internal teams to maintain complicated customizations
  • Implement forward-thinking processes and practices that take automation into account, and can scale to handle changing case volumes
  • Understand the regulatory perspective of how cognitive computing and automation will be governed
  • Train existing resources and provide them with an updated skill set to better prepare them for revised job responsibilities as intelligent automation will displace previous manual tasks

Technology Solution Providers:  Recalibrating the Client-Vendor Model

Leading Safety solution providers, like ArisGlobal, who are incorporating state-of the-art technologies and software development methodologies, will be the key drivers of this transformation. Just like pharmaceutical companies and service providers, technology solution providers will need to recalibrate the traditional client-vendor model. Their focus should be on:

  • Creative pricing models that reflect evolving market demands: working closely with pharmaceutical companies to build a comprehensive return on investment (RoI) model as a result of automation within Pharmacovigilance processes
  • Reduction in implementation and upgrade cycle times
  • Addition of change management and organizational readiness services as key focus areas
  • Leading the drive from customized to standardized workflows and processes, etc.

In our concluding blog in this series, to be published in late March, we will share examples of use cases to showcase how these advanced technologies are already transforming drug safety as we know it.

Using ArisGlobal’s LifeSphere MultiVigilance as an example, we will share how automation functionalities built with combination of artificial intelligence (AI) with robotic process automation (RPA) can help organizations streamline case processing, substantially reducing manual e­ffort to give companies cost savings of up to 50%, realized by higher data quality and compliance.

The post AI, Cloud and Other Advanced Technology: Are You Ready for the New Era of Drug Safety? appeared first on ArisGlobal.

“Are You Ready for the New Era in PV?” to be Presented by ArisGlobal’s VP of Global PV at World Drug Safety Congress

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Miami, Florida – March 28, 2019 – ArisGlobal, LLC, a leading provider of life sciences software that automates core drug development functions for over 200 life sciences companies, will present a session titled “Are You Ready for the New Era in PV?” at the upcoming World Drug Safety Congress Americas 2019  in Philadelphia, PA from April 15-17, 2019.

Aman Wasan, Vice President, Global Pharmacovigilance & Global Client Partners Group, ArisGlobal, will present the session, scheduled for April 16, 12:00-12:22 p.m., as part of the “Next Gen Tech & Data” track. Life sciences have seen many technological advances in recent years, with drug safety being at the cusp of huge changes driven by automation and increasing annual caseloads. During his session, Aman will discuss how:

  • Pharma companies are challenging their internal processes
  • Service providers are having to optimize processes to drive annual cost savings to customers
  • Safety database providers are starting to incorporate cognitive/robotic automation capabilities to redefine/optimize case processing workflow

 

“The huge potential to alleviate the impact of increasing adverse event case volumes, need for better compliance and quality are driving factors for pharmaceutical companies to challenge internal processes in order to incorporate technological advancements such as automation,” said Aman. “For service providers (CROs/KPOs/BPOs), who are under constant pressure to deliver annual cost reductions, these technology advancements can be the holy grail to increasing quality and productivity while reducing costs. With all these moving parts, it is imperative that the overall industry-preparedness level, including those of regulators, be raised.“

ArisGlobal is a Gold Sponsor of the conference and an exhibitor and will be showcasing LifeSphere Safety, its cognitive computing platform, in Booth #21. 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 “Are You Ready for the New Era in PV?” to be Presented by ArisGlobal’s VP of Global PV at World Drug Safety Congress appeared first on ArisGlobal.

AI, Cloud and Other Advanced Technology: Organizational Readiness Is at the Center of This Transformation Journey

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This is the second in a two-part blog series that examines the key areas that pharmaceutical companies, service providers, and solution providers should focus on as technology advancements continue to transform drug safety for the future.

Read our first blog, “Are You Ready for the New Era of Drug Safety” for background information on this discussion.

Clinical safety is changing from a reactive role to a strategic role throughout the product lifecycle. This requires organizational changes and oversight. As case volumes increase, and tougher regulations are introduced that call for more stringent oversight by health authorities, the days of using those circumstances as a justification to request more staff to mitigate the increased workload of collecting and processing data are most likely gone. Today’s reality is one where pharmacovigilance/drug safety departments in life sciences companies are required to do more with less.  

To succeed, organizational readiness now requires a mindset and plan to manage existing challenges and prepare for the unknown ones around the corner.  As shared in our March 14 blog, there are many technology advancements – artificial intelligence (AI), natural language processing (NLP), deep learning, multi-tenant cloud, chat bots and more – that are or will disrupt the status quo way of thinking and working.

While artificial intelligence (AI) and natural language processing (NLP) will streamline adverse event case reporting for the better, providing up to an 80% increase in efficiency in case intake and data entry, that doesn’t mean that  jobs and livelihoods will be lost as a result. Instead, as automation handles repetitive and routine manual tasks, safety departments can use this digital disruption to retool their workforce to address higher order activities such as case assessment, signal detection and risk management activities.

To get ready for the changes ahead, three key areas of focus need to be planned for and addressed:

Change Management

Without question, digital disruption will have an impact on your safety team, as any change means a new and different way of doing something. A Change Management plan must be implemented hand in hand with any proposed change to technology and supporting processes. Gaining the buy-in of your staff is critical, so spend time clearly articulating the purpose of the change and then connect that with their daily tasks and activities. Gain insight from colleagues in other companies who may be ahead of you in this transformation journey, learn from their mistakes and successes, and then adapt that insight to your organization’s culture.

Safety system/database solution providers such as ArisGlobal have created focused groups of life sciences companies that can discuss technological advances, prioritize critical business challenges and make quick decisions to address them with technology. This allows organizations to discuss change management planning in the context of process changes due to technology enablement.

Training

Deploying new software into an organization or department stands a better chance for success when proper training is part of the planned rollout. Helping your staff understand how the new technology / software will improve their work and productivity, and contribute to improved patient outcomes is a good start, but it takes time for people to adjust to changes in their daily work routine. Letting go of familiar processes and learning new behaviors can be hard for some, so giving your staff the time to get properly trained by professional trainers is an essential piece of any plan involving the disruptive change agents discussed in our previous blog. Of course, training and employee success will be achieved faster if the software vendor has created a comprehensive training curriculum leveraging a mix of interactive online training materials and instructor-led sessions that can be delivered in an agile manner, coordinated with the introduction of new processes.  

Learning Development

Finally, building a company that can respond positively to change requires a learning and development strategy built around a framework and plan for re-tooling the capabilities and skills of your team to meet your organization’s business strategy. As LifeSphere MultiVigilance’s automation capabilities help eliminate manual data entry and streamline processes, it’s important to help your staff recognize they will have time for more value-added responsibilities that will make them better qualified to meet the challenges ahead. By providing them the learning and development necessary to undertake what will become new areas of personal growth — case assessment, signal detection and risk management activities – your pharmacovigilance department stands a stronger chance of meeting the demands for the new era of drug safety.

 

The New Era of PV is upon us and novel technologies have the potential to transform drug development processes, automating routine and repetitive manual tasks. With these changes, highly-trained staff can focus on higher value work, consequently replacing certain transactional roles. Have questions on this topic?  We invite you to learn more by viewing our on-demand webcast, “Practical Use Cases of Automation in Pharmacovigilance and Regulatory to Achieve End-to-End Productivity.”

Please send any comments and questions regarding this blog to info@arisglobal.com.

The post AI, Cloud and Other Advanced Technology: Organizational Readiness Is at the Center of This Transformation Journey appeared first on ArisGlobal.

ArisGlobal is Going “all-in” on Amazon AWS. Here is What It Means to our Customers.

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Software systems supported by a cloud-based infrastructure have become a mainstay in today’s global economy. In fact, many organizations have been leveraging the use of cloud technology for well over a decade. Since its inception, cloud technology has continued to evolve and improve, and today Amazon Web Services (AWS) and others offers a cloud infrastructure platform that enables solution providers to deploy and manage their solutions in an orderly, compliant, and efficient manner.

ArisGlobal, part of the more cautious and highly regulated life sciences industry, recognized the benefits of this reality a long time ago. We were one of the very first life sciences solution vendors to deliver software-as-a-service (SaaS-based) could solutions. Today, that momentum continues as we go “all-in on AWS” by moving our entire cloud infrastructure to the AWS platform, the most sophisticated and mature cloud in the industry. This move benefits both ArisGlobal and to our customers.

For ArisGlobal, we can now provide a globally unified, standardized solution on the AWS infrastructure-as-a-service (IaaS) platform to drive compliance and enhance the experiences of all our customers. The entire LifeSphere® platform is now powered by the AWS Cloud, and currently more than 85 of ArisGlobal’s 200+ customers have been migrated, with more to quickly follow.

For our customers, there are several important benefits. These include:

  • Reduced Operating Costs. Measured in both time and money, on-premise computing requires significantly greater preparation, as compared to cloud computing. ArisGlobal customers migrating to the cloud save significantly on the initial setup cost, and ongoing maintenance is taken care of by ArisGlobal. All support, maintenance and incident responses are managed by ArisGlobal, which further reduces the total cost of ownership for ArisGlobal customers.
  • Quick On-Boarding and Deployment. AWS gives us a highly reliable global infrastructure, security, and a broad portfolio of cloud services to host the LifeSphere multi-tenant cloud platform with industry standard configurations. Because of this, customers can be deployed and onboard with increased speed.
  • Unmatched Security. ArisGlobal has robust security framework in place. Our information security is compliant with the industry leading information security standards and regulations like ISO 27001, SOC 2, GDPR & HIPAA. AWS Cloud is also compliant with all the security and privacy standards along with all global regulations.

    In AWS, ArisGlobal has leveraged key security features like Cloud Watch and Cloud trail to closely monitor the traffic and actions performed at API level. Critical functions like Identity & Access Management, Encryption, Log management is also managed by using features of AWS. Capabilities like AWS Guard Duty, which is a Machine Learning based tool, which continuously monitors threats and add industry intelligence to the alerts it generates is used by ArisGlobal for 24/7 monitoring; along with AWS Inspector, which is a vulnerability detection tool. To ensure end to end cyber security, ArisGlobal has deployed an end to end EDR solution called Trend Micro Deep Security.

    At ArisGlobal, all products are tested for security vulnerabilities using IBM AppScan tool and manual code review, following OWASP Top10 guidelines and NIST standards to ensure Confidentiality, Integrity and Availability of data.

  • High Reliability & Availability. On the AWS Cloud, ArisGlobal operates across almost all the 20 AWS Regions and AWS’s 61 Availability Zones. (AZs are essentially the physical data centers of AWS, whereas a Region is a collection of availability zones that are geographically located close to one other.) AWS provides ArisGlobal with prompt and completely on-demand infrastructure provisioning with hours, along with built-in redundancies, all managed by AWS. In addition, ArisGlobal can now schedule and automate application backups, scale up databases in minutes by changing instance type, and have instances automatically moved to a healthy infrastructure in less than 15 minutes in case of a downtime, giving customers improved resiliency and availability. In comparison, companies choosing to stay with on-premise computing, will need to negotiate and purchase more hardware and software as demand requires, and those purchases are permanent.
  • Faster Innovation & Improved Customer Satisfaction. With ArisGlobal’s move to the AWS cloud, we can continue to bring new offerings to the market even faster and with greater efficiency. Every instance of the LifeSphere platform, which covers all primary functions of the product lifecycle – clinical development, regulatory, safety, and medical affairs – will be powered by AWS. These instances will also be powered by NAVA, ArisGlobal’s proprietary cognitive computing engine for process automation, to drive significant efficiency gains.

ArisGlobal recognizes that our customers rely on our technology platform to help bring their therapies to market faster and with greater cost effectiveness. With our continued focus on automating core business processes, and our latest move to AWS Cloud, that goal is being achieved .

Have any questions? Please email us at info@arisglobal.com.

The post ArisGlobal is Going “all-in” on Amazon AWS. Here is What It Means to our Customers. appeared first on ArisGlobal.

ArisGlobal to Present Innovation Theater Presentations at DIA 2019 Focused on Advanced and Leading Technology to Drive Value Across the Entire Organization

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Miami, Florida – May 2, 2019 – ArisGlobal, LLC, a leading provider of life sciences software that automates core drug development functions for over 250 life sciences companies, will present two Innovation Theater sessions at the DIA 2019 Annual Global Meeting to be held in San Diego, CA from June 23-27, 2019. Subject matter experts will present on block chain technology, unified platforms, and automation use cases to improve data quality and business processes within life sciences organizations, with each session suitable for business and IT audiences.

“As pharmaceutical companies face existing challenges and prepare for unknown ones yet to arrive, harnessing the power of advanced technologies is the best way to meet these demands,” Sam Stein, Vice President of Marketing. “ArisGlobal’s Innovation Theater sessions will help companies better understand and prepare for their digital transformation journey, and we will showcase how our LifeSphere® cognitive platform offers an approach that paves the way for innovation to be achieved.”

Can Blockchain Technology Change Life Sciences?” is the ArisGlobal session scheduled for Monday, June 24, 10:15-10:45 a.m. in Regulatory Innovation Theater 2, located in the main exhibit hall.  Emmanuel Belabe, ArisGlobal Associate Vice President – Safety, will help attendees understand how life sciences companies can take advantage of blockchain technology and a blockchain network to change the traditional models of data exchange for the better. Manny will share the potential impact from these changes and how blockchain technology can help meet the challenges of ensuring the safety of current future drugs.

As the life sciences industry moves toward unified regulatory platforms, the data in such systems becomes an important aspect. This will be discussed in the second ArisGlobal session, “Getting More Value from Your Data Through a Unified Regulatory Platform,” scheduled for Tuesday, June 25, 11:40 a.m. – 12:25 p.m.  in Safety Innovation Theater 2. Wim Cypers, ArisGlobal’s Senior Vice President – Regulatory, will highlight use cases where automation can be used to improve business processes to enhance data quality and improved business process efficiencies. He will explore how a unified platform can reach beyond regulatory and how regulatory data can improve compliance across your organization.  Wim will also highlight upcoming technologies which will be able to further provide value to your organization.,.

ArisGlobal is an exhibitor (Booth 2231) and will be showcasing LifeSphere’s innovative and leading end-to-end cognitive platform spanning clinical, regulatory, safety, and medical affairs. Attendees are encouraged to visit and learn more about LifeSphere cognitive solutions.   

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.

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Letter From Our CEO: Nordic Capital Acquires ArisGlobal, Fuels Growth

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It is with great excitement that we announce that Nordic Capital has entered into a definitive agreement to acquire ArisGlobal. Six months ago, ArisGlobal set out on a mission to find a large investor to support our rapid growth moving forward. This was a carefully administered process that required us to engage and vet a number of top healthcare investors as we searched for the best partner for ArisGlobal. Today, I am pleased to inform you that we have found the right one.

Our firm traces its roots back to 1987, when our founder, Deepak Abbhi, pioneered the development of a first-in-industry adverse event management system that would help life sciences firms automate their mission critical global pharmacovigilance functions for patient safety and regulatory compliance. Over these 32 years, we have built a sustainable and growing business that thrives on its partnerships with many life sciences companies and regulatory agencies. These customer relationships, some lasting decades, have allowed us to become a leading healthcare technology company with over 1200 employees across an expansive global footprint.

Today, we are embarking on a new chapter that will accelerate our ability to achieve our mission of being the leading provider of SaaS solutions for pharmacovigilance, regulatory affairs, medical affairs and clinical development. As our two companies began joint discussions, the possibilities of what we might do with Nordic Capital became very compelling. Nordic Capital, through their investment in ERT, a leading clinical technology solutions provider, has a proven life sciences track record and we share a closely aligned vision for the future of the industry. The acquisition gives us immediate access to deep resources and expert guidance that will help us in our journey. For all the reasons mentioned above, our founder, myself, our Board of Directors, and management team all came to believe that the best way – the most exciting way forward for ArisGlobal and our clients – was to join forces with Nordic Capital.

Moving forward, our management team, including myself, will remain dedicated to ArisGlobal full-time and will continue to manage the company as a standalone entity for the years ahead. Our goal is to continue our strong growth through product innovation, customer satisfaction and industry thought leadership. We are confident that the resources and expertise provided by Nordic Capital will help us achieve this. We feel that you, as our valued customer, will benefit from this partnership as well.

Our unwavering focus on your needs will continue to be the core of who we are as a company. It drives the development of our LifeSphere platform and it fuels our passion for becoming the premier innovative technology company in the world.

I am more excited than ever about the future for the ArisGlobal team and our customers.

 

Sincerely,

Sankesh Abbhi
President and CEO
ArisGlobal, LLC

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Nordic Capital acquires majority stake of ArisGlobal to accelerate growth in years ahead.

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Miami, FL. June 16, 2019It is with great excitement that we announce that Nordic Capital has entered into a definitive agreement to acquire ArisGlobal.

Six months ago, ArisGlobal set out on a mission to find a large investor to support its rapid growth. This was a carefully administered process that required close engagement with several top healthcare investors as we searched for the best partner for ArisGlobal. Today, we are pleased to announce that we have found the right one.

Nordic Capital was an obvious choice thanks to their deep experience in healthcare and technology, and a shared vision for the future of drug development software. A world-class firm with a global footprint, Nordic Capital has an extensive record of successful investments in life sciences, including their stewardship of firms like Nycomed, ERT and Acino.

“The last two years have seen significant growth for ArisGlobal. We feel that this growth has validated our approach to the industry and our LifeSphere® platform, and we have a clear vision for the future. To further execute this vision, our team determined that it made sense to partner with an investor that was experienced in scaling a technology company within the life sciences industry. The partnership with Nordic Capital will provide resources in the form of funding, personnel, relationships and industry expertise, that will allow us to take ArisGlobal to the next level. Given our success in recent years, we felt that the time was now to pursue this type of partnership,” added Sankesh Abbhi, ArisGlobal CEO.

ArisGlobal traces its roots back to 1987 when founder Deepak Abbhi pioneered the development of a first-in-industry adverse event management system that would help life sciences firms automate their mission critical global pharmacovigilance functions for patient safety and regulatory compliance. Over 32 years, ArisGlobal has built a sustainable and growing business that thrives on its partnerships with many life sciences companies and regulatory agencies. These customer relationships, some lasting decades, have positioned the company as a healthcare technology leader with over 1200 employees across an expansive global footprint.

Moving forward, ArisGlobal’s management team will remain dedicated to the company full-time and will continue to manage it as a standalone entity for the years ahead.

“The goal is to continue our strong growth through product innovation, customer satisfaction and industry thought leadership. We are confident that the resources and expertise provided by Nordic Capital will help us achieve this. We feel that all our customers will benefit from this partnership as well,” mentioned Sankesh Abbhi.

The ArisGlobal acquisition comes as Nordic Capital readies to expand its already big bet on the investment prospects of the U.S. health-care sector. Since its inception in 1989, the buyout firm has invested a total of €5.4 billion ($6.01 billion) in health-care companies, directing more than 25% of that total to the health-care sector in the U.S.

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.

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Increasing Case Volumes Remain a Top Challenge for Pharmacovigilance Executives

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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. Only 15% considered their case volume increases to be ‘slight.’

The data point above reminds us that increasing ICSR case volumes remain a major challenge within the life sciences industry. A challenge, in fact, that we’ve been working closely with top life sciences customers like the FDA and Johnson & Johnson to solve. Nearly a year-and-a-half ago, we wrote a blog offering advice as to how to address this challenge: “The Push-Pull of Artificial Intelligence in Pharmacovigilance.”

How have your case volumes changed over the period of last 5 years?

  • OUR CASE VOLUMES HAVE DECREASED OVER THE LAST 5 YEARS 0% 0%
  • OUR CASE VOLUMES HAVE REMAINED ROUGHLY THE SAME OVER THE LAST 5 YEARS 2% 2%
  • OUR CASE VOLUMES HAVE INCREASED SLIGHTLY OVER THE LAST 5 YEARS 15% 15%
  • OUR CASE VOLUMES HAVE INCREASED SIGNIFICANTLY OVER THE LAST 5 YEARS 84% 84%

Fast forward to today, and it’s clear from the results of the webinar polling question that this issue is more prevalent than ever. Increasingly stringent regulatory requirements only add to the complexity of the challenge. As volumes grow, budgets for safety case processing are generally not trending upwards at the same pace. Many PV budgets are flat or drug safety teams are being asked to do more with less. The mandate from executive management is clear: find ways to improve productivity.

Given this reality, a PV department’s reasonable action plan can’t be to repeat the same processes and use the same tools but hope for better productivity and quality. Advanced next-gen technologies – cognitive automation that utilizes artificial intelligence (AI) and machine learning (ML) and cloud computing that helps to drive down costs and improve scalability – are proving key to increasing throughput and preparing for the future.

In our next blog, to be published next week, we will discuss the status of strategic planning around automation that’s underway within life sciences organizations. We will also introduce use cases for automation in PV. If you can’t wait until then, view the on-demand webinar and download our white paper “Cognitive Computing in Pharmacovigilance: Revamping Drug Safety Using an Advanced Computing System.”

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

Editor’s Note: ArisGlobal would like to invite you to register to attend a complimentary lunch-and-learn workshop on July 18th 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.

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Pharmacovigilance Executives Are Open to Automation as a Key Process Enabler, but Education Is Key

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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. However, only 64% have a plan in place to solve this challenge using automation, and 27% reported that they don’t know enough about automation to embrace it.

As covered in our first blog in this series, an ongoing and significant increase in ICSR case volumes is challenging today’s pharmacovigilance (PV) department. This was confirmed by 84% of our webinar attendees who, when asked “How have your cases volumes change over the last 5 years?” responded that their organization’s volume increase was significant. This rise in reported adverse events (AEs) impacts organizations from a cost, resource and compliance perspective.

Recent advancements in technology are enabling automation to help address the growing PV challenges organizations face. Cognitive computing, which utilizes artificial intelligence, machine learning and natural language processing, and robotic process automation (RPA), are driving better productivity and case quality. In fact, ArisGlobal has spent the last few years developing this technology around real-world use cases in close partnership with clients like the FDA, Boehringer Ingelheim, Biogen and AbbVie, among others.

Yet, when our webinar attendees were asked “Does your company have a strategic plan for PV Automation? ” responses were a mixed bag. One-third of attendees indicated their company had an automation plan and that it was one of their highest PV priorities. Another 30% shared that they had a plan, but that it wasn’t seen as a current priority. The remaining respondents didn’t have any strategic automation plan either because they didn’t know much about automation (27%) or because it wasn’t viewed as a current priority (9%). With this smaller group, one might surmise that their company’s case volume activity didn’t warrant improved productivity.

Does your company have a strategic plan for PV Automation?

  • NO, BECAUSE WE DON’T KNOW MUCH ABOUT AUTOMATION. 27% 27%
  • NO, BECAUSE WE DON’T THINK AUTOMATION IS A PRIORITY RIGHT NOW. 9% 9%
  • YES, HOWEVER AUTOMATION IS NOT A HIGH PRIORITY FOR US RIGHT NOW. 30% 30%
  • YES, AUTOMATION OF PV PROCESSES IS ONE OF OUR HIGHEST PRIORITIES. 34% 34%

For those where resources are constrained and improved efficiency is desired, moving forward with creating and implementing a PV automation strategy first begins with understanding the inherent value that cognitive computing can enable across core PV processes — duplicate check, case intake, narrative generation, quality check, follow-up processing, and more – for automating manual and repetitive tasks, reducing error, and reducing cost.

ArisGlobal’s real world experience is showing that automation can drive significant productivity gains. For example, the intelligent optical character recognition used by our LifeSphere MultiVigilance solution can significantly reduce data entry effort for structured data, such as Serious Adverse Event (SAE) forms, by as much as 50%. To gain a better understanding of the automation use cases we’ve focused on, ArisGlobal offers a variety of resources to read, view or attend:

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

Stay tuned. In part 3 of this 3-part blog series, to be published next week, we will explore and share more specifics on the various use cases discussed in the June 5 webinar.

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Automation in Pharmacovigilance: A Closer Look at Use Cases

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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 18th 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.

The post Automation in Pharmacovigilance: A Closer Look at Use Cases appeared first on ArisGlobal.

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