Center for Drug Evaluation, CFDA issues standards and procedures for expedited reporting of Safety Data from Clinical Trials in China

Miami, Florida, May 2, 2018 — ArisGlobal, a leading provider of integrated cloud-based software solutions for life sciences, announced that the China FDA, Center of Drug Evaluation has selected and implemented LifeSphere Safety MultiVigilance (also known as ARISc) solution for clinical safety and pharmacovigilance (PV) through its local partner. Two contract research organizations (CROs) – DeltaMed Co. Ltd and R&G PharmaStudies have also chosen LifeSphere Safety MultiVigilance as their Safety/PV solution platform to support pharmaceutical companies in China.

Recently, CFDA was reorganized into new State Drug Administration (SDA) and one of the mandates is to implement a system to enforce manufacturer compliance of adverse events.

“We are glad to announce that CFDA or SDA is the ninth national health authority that has selected ArisGlobal as their safety technology solution provider,” said Sankesh Abbhi, President & CEO of ArisGlobal. “We are very pleased to support Center for Drug Evaluation with LifeSphere Safety MultiVigilance (ARISc) and we look forward to supporting all our customers and partners in China to help them comply with the new CFDA regulations for reporting safety data from clinical trials.”

This new regulation in China for drug safety reporting will require advanced technology for compliance by the industry. LifeSphere Safety MultiVigilance is a ready solution as it offers four key technology advantages:

• Full compliance with the latest ICH standards E2B(R3) with ARISc
• Localized cloud service provided to meet regulatory requirements
• A single database with multi-lingual capabilities, including Chinese, English and Japanese
• Built on industry standard practices (ISP) to bring harmonization to deployments and to streamline upgrades

“ArisGlobal welcomes and applauds the significant steps that CFDA has taken in adopting advanced technological software, which helps them align with the ICH standards,” said Dr. Vivek Ahuja, ArisGlobal Vice President, Global Pharmacovigilance. “A combination of ARISc and an eSubmissions Link being offered as a unique service through our partners in China will help both domestic and multinational MAHs achieve the R3 compliance requirement in a sustainable manner.”

China is rapidly becoming a major market for life sciences innovation and development, and the industry will have a need for all ArisGlobal solutions for safety, clinical, regulatory, and medical affairs. The ArisGlobal LifeSphere® platform, services and expertise allows its customers to meet their wide range of requirements for regulatory compliance and patient safety.

Additional Information

For more on LifeSphere Safety MultiVigilance (ARISc):  https://goo.gl/DBz61B

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 cognitive technology platform, LifeSphere, integrates machine learning capabilities to automate all 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 and Japan.  Visit arisglobal.com, or follow ArisGlobal on LinkedIn and Twitter.

About DeltaMed Co. Ltd

DeltaMed Co. Ltd. is a specialized PV Contract Research Organization (CRO) to provide Knowledge Process Outsourcing (KPO) global standard services to pharmaceutical and healthcare companies.

Headquartered in China with multiple location offices in Beijing, Shanghai, Hangzhou, Wuhan and San Diego, DeltaMed offers PV services including Comprehensive Case Management for English and Chinese Case Processing; Literature AE Search; Signal Detection and Risk Management; Postmarketing Study and Pharmacoepidemiology; and Safety Quality Assurance and Training Services.

About R&G PharmaStudies Co. Ltd.

As one of the top clinical CROs in China, R&G PharmaStudies Co. Ltd. offers all the aspects of Clinical Study, Site Management, Medical Affairs, Pharmacovigilance, Biostatistics and Data Management, PK/PD analysis, Big Molecules Analysis, Isotopic Tracing of Drug Metabolism, and Phase I Clinical Study Center.

R&G’s Pharmacovigilance team is a top one as well as in China CRO industry in terms of size and professional level.

On May 9, 2018, ArisGlobal sponsored a webcast with DIA on the topic of “Practical Use Cases of Automation in Pharmacovigilance and Regulatory E-2-E Productivity.” Two of ArisGlobal’s top thought leaders, David Scanlon, Senior Director of Regulatory Strategy, and Dr.Vivek Ahuja, Vice President of Global Pharmacovigilance, presented a detailed overview of the positioning of how automation is already making and set to make a substantial difference in end-to-end (E-2-E) pharma processes in these two critical areas.

Five related polling questions were posed to the audience of 137 attendees from around the globe, which included several health authorities, 14 of the top 25 pharmaceutical companies, major consulting firms and CROS, and even a few competitors. This two-part blog series shares the analysis of those responses and what they mean to the future of automation in Regulatory and Safety.

The regulatory and pharmacovigilance landscape is evolving substantially with the changing expectations from regulatory authorities. Costs continue to escalate in the face of an increasing number of drugs in the drug development pipeline, as well as a parallel increase in the number of drugs being approved by major regulatory authorities (RAs) globally. Given this reality, the pharma model for how clinical and safety data is acquired and managed throughout the lifecycle of a medicinal product needs to evolve, and pharma needs to explore ways to decrease costs, increase efficiency, and achieve E-2-E productivity.

Polling Question #1: What is the greatest challenge across E-2-E processes?

The start of any transformational journey should begin with assessing what are the primary challenges to be overcome. Our first polling question asked webinar attendees to choose from five possible responses to identify their greatest challenge across their E-2-E processes. The results, which follow, aligned to our understanding, and so we were not surprised by the lack of systems integration, which proved to be the pain point facing the majority of attendees.

Perhaps the only minor surprise was in seeing “data quality” tied for third place rather than ranked second place. Data quality is all about producing attributable, complete, correct, relevant, accurate, current data with data integrity. Our view is that it is not possible to achieve higher order capabilities such as automation without having the foundations in place for quality, integrated, and managed E-2-E data.

Using the CMMI Institute Data Management Maturity (DMM) Model, Safety departments are much higher on the maturity scale in terms of ‘seeing data as critical to survival’ and so have moved quicker towards some of the benefits to be gained from automation. This is not surprising as pharmacovigilance is based upon solid science in terms of the underpinning methods which support the determination of causality and interpretation of the risks and benefits of medicines. Safety has been moving up the scale for the past five to ten years and realizes the strategic benefit that quality data can deliver. Perhaps, for this reason, polling responses from the PV side of the organization may have felt this was already being addressed to some extent, and therefore not as critical of a challenge.

Regulatory, on the other hand, is a bit behind in addressing data quality as compared to Safety. There is certainly an awareness of data importance, but there are still some challenges in the regulatory environment for the information as they respond to increasing demands from regulators to provide structured data in addition to documents.

Polling Question #2: On a scale of 1-5, how would you rate your automation capabilities?

Our second polling question helped everyone gauge where their organization stood on the journey toward automation as compared to others attending the webinar. As previously shared, more than half of the Top 25 Pharmas attended our webcast, and it would be a safe guess that most of those organizations gave themselves a-capabilities rating of “Intermediate.” The 44% who rated their capabilities as “Just beginning” and the 32% “Not yet started” rating clearly show that the vast majority of most companies everywhere are in the early throes of understanding, planning and preparation.

Curious to learn more? You can view the on-demand webcast to learn more about the role automation will have in the day-to-day E-2-E pharmacovigilance and regulatory activities.

Our second and final blog, which will be published shortly, will share the results and feedback from our three other polling questions related to automation benefits, value and adoption hindrances.

Miami, Florida, April 12, 2018 –ArisGlobal, a leading provider of integrated cloud-based software solutions for life sciences, today announced that it has been independently appraised at Development (DEV) Level 3 of the CMMI Institute’s Capability Maturity Model Integration (CMMI)®. The appraisal was performed by SITARA technologies Pvt. Ltd.

CMMI® is a capability improvement approach that provides organizations with the essential elements of effective processes that ultimately improve their processes. An appraisal at Maturity Level 3 indicates the organization is performing at a “defined” level whereby processes are well characterized and understood, and are described in standards, procedures, tools, and methods. The organization’s set of standard processes, which is the basis for Maturity Level 3, is established and improved over time.

“Achieving CMMI-DEV Level 3 appraisal reflects ArisGlobal’s strong focus and commitment to improving the quality of our software solutions,” said Ashok Katti, Chief Operating Officer and President APAC, ArisGlobal. “Our customers can feel confident that we are continuously working to deliver the highest level of customer satisfaction and product quality.”

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

About CMMI® Institute

CMMI Institute is the global leader in the advancement of best practices in people, process, and technology. The Institute provides the tools and support for organizations to benchmark their capabilities and build maturity by comparing their operations to best practices and identifying performance gaps. For over 25 years, thousands of high-performing organizations in a variety of industries, including aerospace, finance, health services, software, defense, transportation, and telecommunications, have earned a CMMI maturity level rating and proved they are capable business partners and suppliers. To learn more about how CMMI can help your organization elevate performance, visit CMMIinstitute.com.

On May 9, 2018, ArisGlobal sponsored a webcast with DIA on the topic of “Practical Use Cases of Automation in Pharmacovigilance and Regulatory E-2-E Productivity.” Two of ArisGlobal’s top thought leaders, David Scanlon, Senior Director of Regulatory Strategy, and Dr.Vivek Ahuja, Vice President of Global Pharmacovigilance, presented a detailed overview of the positioning of how automation is already making and set to make a substantial difference in end-to-end (E-2-E) pharma processes in these two critical areas.

Five related polling questions were posed to the audience of 137 attendees from around the globe, which included several health authorities, 14 of the top 25 pharmaceutical companies, major consulting firms and CROS, and even a few competitors. This two-part blog series shares the analysis of those responses and what they mean to the future of automation in Regulatory and Safety.

The regulatory and pharmacovigilance landscape is evolving substantially with the changing expectations from regulatory authorities. Costs continue to escalate in the face of an increasing number of drugs in the drug development pipeline, as well as a parallel increase in the number of drugs being approved by major regulatory authorities (RAs) globally. Given this reality, the pharma model for how clinical and safety data is acquired and managed throughout the lifecycle of a medicinal product needs to evolve, and pharma needs to explore ways to decrease costs, increase efficiency, and achieve E-2-E productivity.

Polling Question #1: What is the greatest challenge across E-2-E processes?

The start of any transformational journey should begin with assessing what are the primary challenges to be overcome. Our first polling question asked webinar attendees to choose from five possible responses to identify their greatest challenge across their E-2-E processes. The results, which follow, aligned to our understanding, and so we were not surprised by the lack of systems integration, which proved to be the pain point facing the majority of attendees.

Perhaps the only minor surprise was in seeing “data quality” tied for third place rather than ranked second place. Data quality is all about producing attributable, complete, correct, relevant, accurate, current data with data integrity. Our view is that it is not possible to achieve higher order capabilities such as automation without having the foundations in place for quality, integrated, and managed E-2-E data.

Using the CMMI Institute Data Management Maturity (DMM) Model, Safety departments are much higher on the maturity scale in terms of ‘seeing data as critical to survival’ and so have moved quicker towards some of the benefits to be gained from automation. This is not surprising as pharmacovigilance is based upon solid science in terms of the underpinning methods which support the determination of causality and interpretation of the risks and benefits of medicines. Safety has been moving up the scale for the past five to ten years and realizes the strategic benefit that quality data can deliver. Perhaps, for this reason, polling responses from the PV side of the organization may have felt this was already being addressed to some extent, and therefore not as critical of a challenge.

Regulatory, on the other hand, is a bit behind in addressing data quality as compared to Safety. There is certainly an awareness of data importance, but there are still some challenges in the regulatory environment for the information as they respond to increasing demands from regulators to provide structured data in addition to documents.

Polling Question #2: On a scale of 1-5, how would you rate your automation capabilities?

Our second polling question helped everyone gauge where their organization stood on the journey toward automation as compared to others attending the webinar. As previously shared, more than half of the Top 25 Pharmas attended our webcast, and it would be a safe guess that most of those organizations gave themselves a-capabilities rating of “Intermediate.” The 44% who rated their capabilities as “Just beginning” and the 32% “Not yet started” rating clearly show that the vast majority of most companies everywhere are in the early throes of understanding, planning and preparation.

Curious to learn more? You can view the on-demand webcast to learn more about the role automation will have in the day-to-day E-2-E pharmacovigilance and regulatory activities.

Our second and final blog, which will be published shortly, will share the results and feedback from our three other polling questions related to automation benefits, value and adoption hindrances.

MIAMI, FL.  JUNE 6, 2018 — ArisGlobal, LLC, a leading provider of integrated cloud-based software solutions for life sciences, will present two Innovation Theater sessions at the DIA 2018 Annual Global Meeting to be held in Boston, MA from June 24-28, 2018. Both 30-minute sessions present related information on the value that the ArisGlobal LifeSphere® cognitive, cross-domain platform can bring to transforming pharma with a process-driven approach and industry standard practices, with one session focused on clinical development and the other on regulatory affairs.

“Our thirty-plus years of life sciences experience in working with pharmas, CROs and medical device companies of all sizes has culminated in ArisGlobal LifeSphere as an innovative, cognitive platform where its advanced technology is now a true enabler,” said Manish Varma, Chief Strategy Officer, ArisGlobal. “These sessions will show how LifeSphere enables an enterprise-level approach that unifies every facet of the product lifecycle, ensuring that the digital journey is cohesive, streamlined, agile and responsive across systems, regions, and geographies.”

The first session, “A Clinical Perspective: How Cognitive E-2-E Platforms can Transform Productivity in Pharma” is scheduled for Monday, June 25 at 4:45 p.m. in Innovation Theater 2, located in the main exhibit hall. Presented by Vitthal Gouri, ArisGlobal’s Director of Clinical Solutions, attendees will learn how, despite GMP, GCP, GVP and Good Regulatory Practice, inconsistent data provisioning has resulted in ‘silo thinking’ across departments, which has led to disconnected platforms involving their own standards and  weak data governance.

The second session, “A Regulatory Perspective: How Cognitive E-2-E Pharma Platforms can Transform Productivity in Pharma” is scheduled for Wednesday, June 27 at 9:45 a.m. in Innovation Theater 1. In this session, David Scanlon, ArisGlobal’s Senior Director of Regulatory Strategy, will give attendees a Regulatory perspective on how the recent emphasis on data exchange to enhance patient protection has similarly exposed disconnected platforms with weak standards and data governance.

David and Vitthal will explore how clinical and regulatory can seamlessly integrate processes.  Their sessions, while on different days, will tie together the flow of E-2-E processes from the Clinical Trials process through Regulatory Operations within an integrated platform: LifeSphere. Attendees are encouraged to attend both sessions to get the full picture.

ArisGlobal is an exhibitor and will be showcasing ArisGlobal LifeSphere, its cognitive computing platform, in Booth #1710. 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 and Japan. For more information, visit arisglobal.com or follow ArisGlobal on LinkedIn and Twitter.

On May 9, 2018, ArisGlobal sponsored a webcast with DIA on the topic of “Practical Use Cases of Automation in Pharmacovigilance and Regulatory E-2-E Productivity.” Two of ArisGlobal’s top thought leaders, David Scanlon, Senior Director of Regulatory Strategy, and Dr.Vivek Ahuja, Vice President of Global Pharmacovigilance presented a detailed overview of the positioning of how automation is already making and set to make a substantial difference in end-to-end (E-2-E) pharma processes in these two critical areas. This is the second and final in a 2-part blog series that has taken these audience responses, and shares our thinking about what they mean to the future of automation in Regulatory and Safety.

In part 1 of this blog series, we gave feedback regarding two of the polling questions asked during the webinar. The first poll asked webinar attendees to identify the greatest challenge across their E-2-E processes. At 30% response, “Lack of systems integration” was the primary challenge, followed by 22% choosing “Silo’d” approach within organization.”

Our second polling question, “How would you rate your automation capabilities,” helped attendees gauge where their organization stood on the journey towards automation as compared to others. At 76%, clearly the vast majority of attendees are either just beginning (44%) or haven’t even started yet (32%). Clearly, many companies are still exploring and trying to understand just how automation can be best used within their organization.

Automation & Pharmacovigilance

For pharmacovigilance, Dr. Vivek Ahuja gave practical use cases for automation spanning Case Processing of Spontaneous Reports, Duplicate Case Detection & Management, Auto-Data Entry, Identification of Relevant ICSRs, Redaction, Medical Literature Monitoring, Data Privacy, and Intake and Triage.

Polling Question #3: How far along the road would you say you are in realizing benefits from automation in safety?

Our third polling question asked attendees to rate the benefits they have realized from automation in safety. Of the 73 responses received, 58% said that they are just beginning to realize benefits or only beginning to understand the possibilities. There were a few attendees (16%) that mentioned that the automation technologies were already in development.

Several reports have previously identified leadership support as an important factor for successful adoption of automation technologies. Notably, in this poll, only 4% of respondents said that “business leadership is fully engaged” in realizing benefits from automation adoption strategies.

“The day that business and IT leadership are fully engaged will be the tipping point when everyone will begin using automation,” shared Dr. Ahuja. “In my opinion, the prophecy of pharmacovigilance is that in the next three to five years, PV will turn completely upside down, and automation will become par for the course. There will be many available applications for PV automation.”

Polling Question #4: In your organization, in which of the following areas would automation create maximum value?

Typically, automation has the highest potential for application in areas involving manual and repetitive tasks. In pharmacovigilance activities such as data entry, segregation of relevant versus irrelevant reports, and scanning through large number of literature papers, can be categorized as ‘manual and repetitive’ tasks. With four possible responses to choose from — Manual Segregation, Data Entry Population, Performing Assessment Automatically, or All of the Above – our fourth polling question asked attendees to identify which area would best benefit from automation in their organization. A total of 80 responses were received. Not surprising, “All of the above” was the clear winner as everyone sees value in all of these areas.

Automation & Regulatory Affairs

During the webinar, David Scanlon shared how the burden of meeting compliance and business requirements for manufacturing, marketing, patents, systems, legal, pharmacovigilance, clinical, regulatory, data and documents keeps regulatory affairs departments extremely busy.

With lots of organizational mergers and acquisitions taking place, redaction is certainly an important automation activity in the exchange of documents. But documents also need to be exchanged in an effective way, which often takes a bit of work. Optimizing those regulatory activities with internal processes requires greater efficiencies in regulatory information management systems (RIMS), document management, and other ancillary systems.

So, like for pharmacovigilance, managing the regulatory data that surrounds these areas and the standards to which we develop it, is where automation offers a new way to handle the increasing pressures for reduced costs and the increasing requirements to do more work based as regulators demand more information.

“There has been a lot of hype and hyperbole in the press about automation. Many senior leaders in pharma are starting to identify automation as a real opportunity to transform their business and set the elusive stage for greater productivity,” shared David.

Polling Question #5: What is the biggest hindrance in adopting automation technologies?

Our final polling question asked attendees to identify their biggest hindrance to adopting automation technologies. Here, 71 responses were received, and a little more even with one another, but “Uncertainty on [data] quality” was the top selection. This makes perfect sense since having data quality challenges makes it difficult to implement certain technologies. The second-leading response, “ROI does not justify investment” is perhaps justifiable at the moment in terms of benefit, but this will change over the next five to ten years as we see worldwide standardization on medicinal product initiatives like IDMP are embraced and take hold.

Where many solution vendors and life science organizations are still thinking and wondering how to leverage automation, ArisGlobal is leading the way with LifeSphere®. We hope you found this blog series helpful as you and your organization begin your automation journey. A number of audience questions were asked and answered during this webinar. Curious to learn more? You can view the on-demand webcast to learn more about the role automation will have in the day-to-day E-2-E pharmacovigilance and regulatory activities.

MIAMI, FL.  JUNE 12, 2018 — ArisGlobal, LLC, a leading provider of integrated cloud-based software solutions for life sciences, will present will present at the 2^nd World Congress on Regulatory Affairs for Medical Devices to be held in London, UK, from July 2-3, 2018, on the topic “Can Medical Devices Learn from Pharma: Shared Challenges, Similar Opportunities!”

David Scanlon, Senior Director Regulatory Strategy at ArisGlobal, will present on July 2, 1:30 to 2:00 pm, as part of the conference’s session 2 track. Mr. Scanlon will draw upon the similarities and differences observed between the pharmaceutical and medical device industries, and will describe the potential opportunities to leverage learning from both industries as they move towards more global regulatory coherence.

“My session will focus on how data can be viewed as an asset, opening up opportunities for automation and productivity gains,” said David. “This will require more integrated end-to-end (E-2-E) solutions that have data governance and data exploitation enabled within their design.”

ArisGlobal is an exhibitor (Booth #2) and will be showcasing LifeSphere Regulatory, its cognitive computing platform for regulatory affairs, and REGISTER for Medical Devices, the Regulatory Information Management System (RIMS) that enables real-time tracking throughout every step of the device registration process. Attendees are invited to meet with ArisGlobal staff to learn about its innovative and leading regulatory affairs 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 and Japan. For more information, visit arisglobal.com or follow ArisGlobal on LinkedIn and Twitter.

MIAMI, FL.  JUNE 12, 2018 — ArisGlobal, LLC, a leading provider of integrated cloud-based software solutions for life sciences, will present will present at the 2^nd World Congress on Regulatory Affairs for Medical Devices to be held in London, UK, from July 2-3, 2018, on the topic “Can Medical Devices Learn from Pharma: Shared Challenges, Similar Opportunities!”

David Scanlon, Senior Director Regulatory Strategy at ArisGlobal, will present on July 2, 1:30 to 2:00 pm, as part of the conference’s session 2 track. Mr. Scanlon will draw upon the similarities and differences observed between the pharmaceutical and medical device industries, and will describe the potential opportunities to leverage learning from both industries as they move towards more global regulatory coherence.

“My session will focus on how data can be viewed as an asset, opening up opportunities for automation and productivity gains,” said David. “This will require more integrated end-to-end (E-2-E) solutions that have data governance and data exploitation enabled within their design.”

ArisGlobal is an exhibitor (Booth #2) and will be showcasing LifeSphere Regulatory, its cognitive computing platform for regulatory affairs, and REGISTER for Medical Devices, the Regulatory Information Management System (RIMS) that enables real-time tracking throughout every step of the device registration process. Attendees are invited to meet with ArisGlobal staff to learn about its innovative and leading regulatory affairs 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 and Japan. For more information, visit arisglobal.com or follow ArisGlobal on LinkedIn and Twitter.

Strategic partnership between Celegence and ArisGlobal enables Life Sciences Companies to Leverage an Innovative, Efficient and Cost-effective Model for Regulatory Compliance

Miami, Florida, June 14, 2018 – ArisGlobal, a leading provider of integrated cloud-based software solutions for life sciences, announced Celegence, a global regulatory affairs services provider, as its preferred partner for Regulatory Business Process-as-a-Service (BPaaS). While Celegence’s service portfolio covers the end-to-end product lifecycle management, the initial partnership will be focused on ArisGlobal’s LifeSphere RIMS & LifeSphere IDMP solutions.

“Celegence’s leadership team, with a combined experience of over 25-years within the pharma industry and 15 years in Regulatory Affairs, make them an obvious choice for preferred partner status with ArisGlobal,” commented Manish Varma, Chief Strategy Officer of ArisGlobal. “They have a strong and proven record of both product and service delivery and are certified in the delivery of our solutions.”

Celegence has successfully supported ArisGlobal by providing LifeSphere IDMP and LifeSphere RIMS-related business services to two of the top five global pharmaceutical companies over the past year. One of these customers conducted a proof-of-concept for LifeSphere IDMP, leveraging Celegence’s expertise in IDMP requirements and data management for iteration 1 of the guideline.

The partnership between ArisGlobal and Celegence also means that life sciences companies can start to leverage the business process-as-a-service (BPaaS) model for Regulatory Affairs operations. For companies in the industry who wish to leverage this model, Celegence will provide not only the business services related to IDMP or RIMS data management, but also manage the underlying ArisGlobal technology. This strategic offering will help the industry reduce investment in terms of both time and cost while increasing transparency with business-service-related performance metrics.

As the preferred partner of ArisGlobal, Celegence will also join the company’s Regulatory Industry Standard Practice (ISP) board.  In this role, Celegence champions its customers’ business requirements for consideration in the product roadmap. This working relationship allows both Celegence and ArisGlobal to better serve both existing and future customers.

“Through our partnership, Celegence is able to provide the life sciences industry with streamlined processes and a cost efficient model that enables our customer to reduce the burden of managing multiple vendors, ongoing maintenance and fiscal challenges. Clients can focus on what matters most and continue to maintain compliance,” said Sonia Veluchamy, Chief Executive Officer of Celegence.

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 cognitive technology platform, LifeSphere, integrates machine learning capabilities to automate all 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 and Japan. Visit arisglobal.com, or follow ArisGlobal on LinkedIn and Twitter

About Celegence

Celegence helps Life Sciences companies navigate complex global regulatory requirements by providing consulting services and solutions dedicated to Regulatory Affairs. Our depth of experience and an extensive delivery capability allows Regulatory Affairs teams to operate more efficiently, reduce cost, and improve compliance. For more information, visit www.celegence.com.

Best of breed PV services and technology platform redefines regulatory compliance speed, cost and analytical insight paradigm

Miami, FL. June 26, 2018 – ArisGlobal, a leading provider of integrated, multi-tenant cloud-based software solutions for life sciences and APCER Life Sciences the industry preferred end-to-end pharmacovigilance services provider, today globally unveiled the first seamlessly integrated cloud technology and pharmacovigilance services platform. The joint managed services plugs in one of the most critical PV compliance gaps of the pharma industry with proven gold blueprint from 40+ organizations and regulatory bodies in 160 countries.

ArisGlobal’s LifeSphere Safety MultiVigilance forms the robust technology base for the joint go to market. APCER is also working closely with ArisGlobal to develop cutting-edge cognitive automation technology in order to optimize manual pharmacovigilance processes. This new platform will allow APCER Life Sciences to continue to grow geographically as well as with the depth and breadth of services.

ArisGlobal is building the next-generation, automation-enabled platform that will revolutionize the way ICSR case processing is done today. ArisGlobal have deployed a highly skilled team comprising of domain experts, backed by cognitive computing experts, in order to deliver this automation enabled safety system

“Many of today’s marketing authorization holders no longer want the burden of selecting, updating and maintaining in house IT systems to ensure regulatory compliance,” said Sankesh Abbhi, President & CEO ArisGlobal. “CROs are increasingly being asked to take on this responsibility, and they need a robust solution that will not only meet current needs but will quickly handle evolving compliance requirements in the years to come. LifeSphere Safety MultiVigilance more than fulfills this sustainability and scalability expectation while maintaining ‘water-tight’ security demarcation between various tenants (CRO customers) on the multi-tenant platform.”

Faster onboarding of any new customer on the LifeSphere Safety MultiVigilance platform becomes as simple as ‘plug and play’ due to the pre-configured, tested and ready-to-use application provided and hosted for the CRO. The solution is based on industry best practices and leverages advanced cognitive automation technology to optimize case processing, leading to efficiency and financial gains. Transaction-based pricing helps in keeping the total cost of ownership low thereby creating a ‘win-win’ situation for CROs as well as their customers. The ability to monitor and analyze the safety data across multiple tenants using interactive views empowers the CRO to measure better and thereby manage better.

APCER has already been using ARISg, ArisGlobal’s on-premise safety database. The decision to adopt ArisGlobal’s Multi-tenant LifeSphere® Safety MultiVigilance is rooted in its cost performance and compliance. APCER’s customers will now have a more integrated solution from clinical to post-marketing PVG. APCER is now able to provide customer base of 40+ marketing authorization holders on Multi-tenant LifeSphere® Safety MultiVigilance platform, assured regulatory compliance from clinical through post-marketing, using cognitive automation technology to optimize pharmacovigilance processes.

“Our decision to upgrade to LifeSphere Safety MultiVigilance was based on better integration, improved case management, reduced costs, and the ability to reach even higher compliance requirements of our customers and regulators. This integrated solution allows APCER to focus on the unique requirements of our customers with a tool that is as compliant, and collaboration focused as we are” said Ravi Menon, Chairman of the Board.

“We feel confident that we now have stronger foundation needed to ensure compliance with utmost efficiency and productivity. Our customers will benefit with the integrated managed services based on industry standard blueprint coupled with output /transaction-based model. said Gopal Menon, Vice Chairman APCER Life Sciences.

Our scientific, regulatory & operations knowledge is key to help build cognitive automation platform with ArisGlobal that will be the cornerstone in Drug Safety lifecycle management- through better quality and efficiency. The Go-to market alignment between us is slated to bring in faster & better technology adoption within targeted customer segments,” said Kunwar B. Kishore Arora, Managing Director India, Global COO- APCER Life Sciences.

Leveraging ArisGlobal’s professional services team, ArisGlobal customers who move to LifeSphere Safety MultiVigilance will realize a seamless upgrade and quick onboarding. Additionally, all customers will realize a lower total cost of ownership as LifeSphere is a multi-tenant platform that future-proofs customers against changing regulations, upgrade and maintenance costs.

Learn more:  LifeSphere Safety MultiVigilance

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

About APCER:

APCER, the regulatory services business unit of the APC Group, is a leading end-to-end global Pharmacovigilance provider companies. APCER has been providing comprehensive drug safety, medical information, medical writing, regulatory, quality assurance and auditing services to pharmaceutical, biologics and consumer product companies since 2007. APCER has five offices which house more than 700 employees globally: Princeton, NJ, USA; London, England, UK; Wan Chai, Hong Kong; New Delhi and Ahmedabad, India.