Manish Varma, Peter Leister, and Katsuhiko Niga Join Organization to Grow and Support Global Customer Base

Miami, Florida, April 5th, 2018– ArisGlobal, a leading provider of an integrated, cloud-based suite of products with unmatched capabilities in solving the real-world research and development needs of life sciences organizations, today announced the expansion of its global offices and appointment of three key executives to the company’s management team. The executive appointments are focused on driving sustainable growth and bringing innovation at scale through its products to the life sciences industry.

Manish Varma has joined ArisGlobal as Chief Strategy Officer. Manish brings to ArisGlobal many years of executive leadership experience of consistently elevating organizational performance and delivering game-changing solutions.  He has created customer-focused organizations that provide superior products and services through emerging technologies and platform-based innovation models. Prior to ArisGlobal, he led the technology function as Global Vice President of Strategy, Portfolio, and Product Management at Janssen Pharmaceutical Companies of Johnson & Johnson.

“I cannot imagine a more exciting opportunity than joining ArisGlobal,” said Manish. The company is a visionary market leader that is transforming the core functions of clinical, regulatory, safety & pharmacovigilance, and medical affairs. This offers me a perfect opportunity to apply my experience, skills, and passion for developing differentiated product-centric strategies to drive market leadership and company’s growth”

Peter Leister has joined ArisGlobal as Chief Commercial Officer. Peter has over 20 years of experience in the Pharmaceutical & Life Sciences sector, and a strong track record of success as an entrepreneur and senior-level business coach in the Life Sciences R&D and health economics. Peter also has vast business development expertise and proven management skills. Prior to joining ArisGlobal, Peter was the Chief Strategy & Sales Officer at Genpact Pharmalink, prior to that, Peter was Partner at Accenture, where he led the Life Science R&D business in the DACH region. Peter was also a consultancy professional at IBM and PricewaterhouseCoopers.

“ArisGlobal’s customer base is impressive and includes many companies who have been with them for a long time.” said Peter. “With the drive and momentum to innovate that ArisGlobal has inherited and recently even renewed (focusing on cognitive computing and fully exploiting Artificial Intelligence across domains like PV, Regulatory, Clinical, Quality and Risk management) it offers an enormous potential for Life Sciences companies, especially in today’s rapidly changing and increasingly global ecosystem.”

Katsuhiko Niga has joined ArisGlobal as Japan Regional Director. Katsuhiko brings over 20 years of leadership experience in life sciences industry. Prior to joining ArisGlobal, Katsuhiko served as President, WorldOne K.K., medical research organization.  Prior to that, Katsuhiko was President, Phase Forward. Katshuhiko also worked at pharmaceutical companies, such as Boehringer Ingelheim Japan and GlaxoSmithKline in leadership roles. Katsuhiko was also the founder of Luminary Medical K.K., a market research organization.

“I welcome the opportunity to join an industry-leading team where I can utilize my deep industry experience to support ArisGlobal’s customers in the Japanese, Chinese and Korean markets,” commented Katsuhiko. “ArisGlobal is committed to supporting and growing their customers in this region.”

Given the recent dramatic growth worldwide, the company has opened a new office in Darmstadt, Germany, to stay close to its customers in Western Europe and Shanghai, China to meet the expanding need for regulation working in close collaboration with local health authorities. The company is headquartered in Miami, Florida and has offices in New Jersey, Ireland, United Kingdom, Italy, Japan, India, and China.

“We are thrilled to have Manish, Peter and Katsuhiko join the ArisGlobal team” said Sankesh Abbhi, CEO of ArisGobal. “Together, they bring an unparalleled level of executive leadership, a wealth of enterprise technology and business experience, and a passion for developing next generation, AI-based products. Their addition to the ArisGlobal executive team, along with our new office footprint, will further enhance our ability to deliver transformation at an even more dynamic and faster pace.”

ArisGlobal is exhibiting at DIA Europe 2018, Booth 20, and will be showcasing its ArisGlobal LifeSphere® cognitive computing platform across Safety, Regulatory, Clinical and Medical Affairs.

About ArisGlobal

ArisGlobal is a visionary technology company that’s transforming the way today’s most successful pharmaceutical, med device, CRO and biotech companies develop breakthroughs, and bring new products to market. The ArisGlobal LifeSphere® cognitive technology platform 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.

MIAMI, FL.  April 11, 2018 — ArisGlobal, LLC, a global leader in providing cloud-based software solutions for the life sciences, will present at the eRegulatory Summit to be held in Lisbon, Portugal, from April 24 to 26, 2018, on the topic “Automation in Regulatory – Excited or Scared: a near reality or distant dream?”

David Scanlon, Senior Director Regulatory Strategy at ArisGlobal, is scheduled to present on April 24, 3pm to 3.35pm, as part of the conference’s Regulatory Information Management & IDMP Compliance track. Mr. Scanlon will explore real productivity gains from automation in other settings to identify applicability for regulatory professionals.

“Regulatory information systems, seen in the context of E-2-E processes across the R&D value chain, present opportunities for regulatory informatics and analytics and automation,” Mr. Scanlon says. “My presentation will look at the evolution and future possibilities for regulatory information management, and how new automation technologies may drive quality improvements while reducing costs. I will address these opportunities in the context of challenging constraints around the speed of regulatory changes globally.”

ArisGlobal is a sponsor of the eRegulatory Summit. Attendees are invited to meet Mr. Scanlon and other ArisGlobal staff members to learn about its innovative and leading LifeSphere Regulatory 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, 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.

Manish Varma, Peter Leister, and Katsuhiko Niga Join Organization to Grow and Support Global Customer Base

Miami, Florida, April 5th, 2018– ArisGlobal, a leading provider of an integrated, cloud-based suite of products with unmatched capabilities in solving the real-world research and development needs of life sciences organizations, today announced the expansion of its global offices and appointment of three key executives to the company’s management team. The executive appointments are focused on driving sustainable growth and bringing innovation at scale through its products to the life sciences industry.

Manish Varma has joined ArisGlobal as Chief Strategy Officer. Manish brings to ArisGlobal many years of executive leadership experience of consistently elevating organizational performance and delivering game-changing solutions.  He has created customer-focused organizations that provide superior products and services through emerging technologies and platform-based innovation models. Prior to ArisGlobal, he led the technology function as Global Vice President of Strategy, Portfolio, and Product Management at Janssen Pharmaceutical Companies of Johnson & Johnson.

“I cannot imagine a more exciting opportunity than joining ArisGlobal,” said Manish. The company is a visionary market leader that is transforming the core functions of clinical, regulatory, safety & pharmacovigilance, and medical affairs. This offers me a perfect opportunity to apply my experience, skills, and passion for developing differentiated product-centric strategies to drive market leadership and company’s growth”

Peter Leister has joined ArisGlobal as Chief Commercial Officer. Peter has over 20 years of experience in the Pharmaceutical & Life Sciences sector, and a strong track record of success as an entrepreneur and senior-level business coach in the Life Sciences R&D and health economics. Peter also has vast business development expertise and proven management skills. Prior to joining ArisGlobal, Peter was the Chief Strategy & Sales Officer at Genpact Pharmalink, prior to that, Peter was Partner at Accenture, where he led the Life Science R&D business in the DACH region. Peter was also a consultancy professional at IBM and PricewaterhouseCoopers.

“ArisGlobal’s customer base is impressive and includes many companies who have been with them for a long time.” said Peter. “With the drive and momentum to innovate that ArisGlobal has inherited and recently even renewed (focusing on cognitive computing and fully exploiting Artificial Intelligence across domains like PV, Regulatory, Clinical, Quality and Risk management) it offers an enormous potential for Life Sciences companies, especially in today’s rapidly changing and increasingly global ecosystem.”

Katsuhiko Niga has joined ArisGlobal as Japan Regional Director. Katsuhiko brings over 20 years of leadership experience in life sciences industry. Prior to joining ArisGlobal, Katsuhiko served as President, WorldOne K.K., medical research organization.  Prior to that, Katsuhiko was President, Phase Forward. Katshuhiko also worked at pharmaceutical companies, such as Boehringer Ingelheim Japan and GlaxoSmithKline in leadership roles. Katsuhiko was also the founder of Luminary Medical K.K., a market research organization.

“I welcome the opportunity to join an industry-leading team where I can utilize my deep industry experience to support ArisGlobal’s customers in the Japanese, Chinese and Korean markets,” commented Katsuhiko. “ArisGlobal is committed to supporting and growing their customers in this region.”

Given the recent dramatic growth worldwide, the company has opened a new office in Darmstadt, Germany, to stay close to its customers in Western Europe and Shanghai, China to meet the expanding need for regulation working in close collaboration with local health authorities. The company is headquartered in Miami, Florida and has offices in New Jersey, Ireland, United Kingdom, Italy, Japan, India, and China.

“We are thrilled to have Manish, Peter and Katsuhiko join the ArisGlobal team” said Sankesh Abbhi, CEO of ArisGobal. “Together, they bring an unparalleled level of executive leadership, a wealth of enterprise technology and business experience, and a passion for developing next generation, AI-based products. Their addition to the ArisGlobal executive team, along with our new office footprint, will further enhance our ability to deliver transformation at an even more dynamic and faster pace.”

ArisGlobal is exhibiting at DIA Europe 2018, Booth 20, and will be showcasing its ArisGlobal LifeSphere® cognitive computing platform across Safety, Regulatory, Clinical and Medical Affairs.

About ArisGlobal

ArisGlobal is a visionary technology company that’s transforming the way today’s most successful pharmaceutical, med device, CRO and biotech companies develop breakthroughs, and bring new products to market. The ArisGlobal LifeSphere® cognitive technology platform 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.

MIAMI, FL.  April 11, 2018 — ArisGlobal, LLC, a global leader in providing cloud-based software solutions for the life sciences, will present at the eRegulatory Summit to be held in Lisbon, Portugal, from April 24 to 26, 2018, on the topic “Automation in Regulatory – Excited or Scared: a near reality or distant dream?”

David Scanlon, Senior Director Regulatory Strategy at ArisGlobal, is scheduled to present on April 24, 3pm to 3.35pm, as part of the conference’s Regulatory Information Management & IDMP Compliance track. Mr. Scanlon will explore real productivity gains from automation in other settings to identify applicability for regulatory professionals.

“Regulatory information systems, seen in the context of E-2-E processes across the R&D value chain, present opportunities for regulatory informatics and analytics and automation,” Mr. Scanlon says. “My presentation will look at the evolution and future possibilities for regulatory information management, and how new automation technologies may drive quality improvements while reducing costs. I will address these opportunities in the context of challenging constraints around the speed of regulatory changes globally.”

ArisGlobal is a sponsor of the eRegulatory Summit. Attendees are invited to meet Mr. Scanlon and other ArisGlobal staff members to learn about its innovative and leading LifeSphere Regulatory 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, 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.

Top 5 life sciences organization joins forces with ArisGlobal to collaborate on the development of industry standard practices for cognitive platform for regulatory affairs and regulatory compliance

Miami, Florida, April 17, 2018– ArisGlobal, a leading provider of integrated cloud-based software solutions for life sciences, announced that LifeSphere Regulatory, the unified platform for regulatory affairs and regulatory compliance, has reached its first major milestone. The recent signing of a Top 5 global pharmaceutical company, including their agreement to provide collaborative input toward industry standard practices, further cements ArisGlobal as a life sciences solutions leader in regulatory affairs solutions. In addition, enhanced, new capabilities that offer a unique approach for separating what is done at headquarter and affiliate levels now make more efficient use of the system to deliver greater efficiencies.

“Our customers reap the best of our past, current and future worlds,” said Wim Cypers, Senior Vice President, Regulatory – ArisGlobal. “First, they reap the benefit of our 20-plus years of leadership experience and knowledge in regulatory affairs. Second, they already can now leverage all of LifeSphere Regulatory’s capabilities on the cloud for reduced total cost of ownership. And because of cloud deployment, they are already positioned for our planned releases for LifeSphere Publishing and LifeSphere Analytics, scheduled for late 2018.”

The Top 5 pharmaceutical company who recently signed on as a LifeSphere RIMS customer is part of a collaborative partnership that includes Top 20 customers. Working together with ArisGlobal subject matter experts and product management, these companies will provide significant input that will enable ArisGlobal to capture and codify those thought processes and methods and apply an industry standard best-practices approach to each solution.

The LifeSphere Regulatory platform offers unified modules for regulatory information management, IDMP/compliance management, and regulatory submissions tracking.

ArisGlobal is exhibiting at DIA Europe 2018, Booth 20, scheduled for April 17-19, in Basel, Switzerland, and at eRegulatory Summit, Booth 9, scheduled for April 24-26, in Lisbon, Portugal.

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.

Miami, Florida, April 26, 2018 – ArisGlobal, a leading provider of integrated cloud-based software solutions for life sciences, today announced LifeSphere EV Triage, an intuitive, cloud-based plug-in tool that automates the process of triaging and reconciling applicable individual case safety reports (ICSRs) involving a marketing authorization holder’s (MAH) medicinal products from other non-specific cases. The plug-in tool features an intuitive user interface and is fully interoperable with any pharmacovigilance (PV) system or E2B converter tool. As a result, greater efficiencies are achieved as the amount of manual effort involved is significantly reduced.

“As part of new EudraVigilance (EV) pharmacovigilance legislation enacted in November 2017, today’s Marketing Authorization Holders (MAHs) no longer receive ICSRs from National Competent Authorities,” said Dr. Vivek Ahuja, Vice President, Global Pharmacovigilance, ArisGlobal. “Now they must download safety cases from EVWEB, which are based only on the active substance as per the hierarchy of XEVMPD. For most products, it is estimated that the majority of the cases downloaded are not relevant to a MAH’s product. This manual process involves a significant manual effort and creation of Excel spreadsheets to determine which ones are specific to a company. LifeSphere EV Triage entirely removes that pain point and replaces it with efficiency, ease and speed.”

For ICSR triage, upon downloading the XML ZIP file from EVWEB, LifeSphere EV Triage unzips the file and runs an auto-match algorithm that is based on the MAH’s product-specific tags, such as local trade name, substance name/ingredients, form of administration, route of administration, and country. Based on those tags, incoming reports are then segregated into “Applicable ICSRs,” which are sent for further processing to the company’s PV system, and “Potential ICSRs,” which are archived for future reference.

The plug-in tool also directly imports relevant cases to LifeSphere Intake and Triage, a sophisticated case triage solution that enables drug and device companies to manage the intake, receipt and triage of adverse events (AEs) automatically from a wide range of sources, including email, fax, online portal, electronic gateways and mobile apps.

For easier and more thorough case reconciliation, LifeSphere EV Triage extracts data if needed and checks how many ICSRs were received, imported and rejected.

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.