New Life Sciences Solution Supports, Enables and Simplifies Compliance Across
all Four Stages of the IDMP Maturity Curve with a Single Platform
TYSONS, Va., June 27, 2016 – CSC (NYSE: CSC), a global leader in next-generation IT services and solutions, today announced the launch of Identification of Medicinal Products As-a Service (IDMPaaS), a collaboration with ArisGlobal to deliver a cloud-hosted offering for life sciences companies.
IDMPaaS provides access to regulatory information management (RIM) solutions, drug safety monitoring software for pharmacovigilance, business process services, and risk management analytics to achieve compliance with emerging IDMP requirements.
IDMPaaS includes initial consulting to help life sciences organizations understand their IDMP responsibilities, along with CSC’s FirstDoc for content management and ArisGlobal’s agIDMP for data collection, review and submission – both delivered through a data factory hosted in CSC’s secure cloud environment. The result is a service package designed to scale in response to the evolving needs of life sciences organizations as they progress through the four stages of the IDMP maturity curve – foundation, data management, compliance, and business benefits.
In addition, CSC has entered into an agreement with ArisGlobal to sell, host and support ArisGlobal’s RIM and IDMP products. The agreement will provide clients with an implementation partner that has proven life sciences expertise for ArisGlobal’s products on a global scale. It also creates a platform approach to RIM and IDMP solution provision.
“IDMP regulatory uncertainty and delays in guidance are rippling through the industry, creating new problems for life science CIOs (risk, uncertainty, unclear compliance requirements and so on),” wrote Michael Shanler of Gartner. “As the IDMP deadline approaches, life science CIOs must quickly transition from gap analysis to solidifying the short-term compliance efforts, and balance those with long-term vision as those initial investments are made. Strategy determination is complicated by the comprehensiveness of the data integration required across a broad swath of IT applications and choice that it presents in short- and long-range objectives.”1
IDMP is a set of emerging international standards designed to provide a common, consistent and unambiguous way of identifying medicinal products across different regions of the world. The intent is to simplify and improve a range of regulatory activities, including product registration, lifecycle management, pharmacovigilance and risk management.
“CSC helps life sciences enterprises innovate and grow by digitizing the life sciences value chain,” said Steve Andrade, global general manager, CSC Life Sciences. “We have a strong position providing innovative products and services that support regulatory information management, and we are looking to address the point where RIM and IDMP come together. CSC’s strength as a global enterprise and industry expertise bring the scale to support the largest life sciences organizations in the world.”
“We’ve been providing advice and guidance on IDMP to our clients for a number of years,” said Joel Finkle, head of CSC’s IDMP practice. “Through those engagements, it has become clear
that clients need an integrated approach to drive pace and efficiency, which is why we’ve designed IDMPaaS – a first of type complete solution.”
“CSC and ArisGlobal have complementary products and share a vision of using digital transformation to provide value to life sciences organizations,” said Deepak Abbhi, chief executive officer of ArisGlobal. “It makes great sense for our two organizations to work together to streamline the way our mutual customers address their IDMP responsibilities.”
CSC in Life Sciences
CSC has been delivering innovative technology solutions to life sciences for over ten years, and is a leading provider of regulatory information management (RIM) solutions and business process services. CSC leverages its extensive software capability to build products and services that help digitize the life sciences value chain. Learn more about how ArisGlobal and CSC align to deliver a scalable IDMP platform during a recent Town Hall. Read more about the digital transformation journey of healthcare and life sciences organizations.
Gartner, Delayed and Confusing IDMP Compliance Requirements Demand Life Science CIOs Pursue a Two-Part Strategy, Michael Shanler 21 January 2016
CSC (NYSE: CSC) leads clients on their digital transformation journeys. The company provides innovative next-generation technology services and solutions that leverage deep industry expertise, global scale, technology independence and an extensive partner community. CSC serves leading commercial and international public sector organizations, including some of the world’s leading healthcare providers. CSC is a Fortune 500 company and ranked among the best corporate citizens. For more information, visit us at www.csc.com and www.csc.com/healthcare.
ArisGlobal’s cloud-based solutions facilitate global drug development and regulatory compliance within the life sciences and healthcare industries. Its cloud platform supports the entire product life cycle including clinical development, regulatory affairs, pharmacovigilance and medical communications. Hundreds of drug and device manufacturers, CROs and regulatory agencies leverage ArisGlobal’s advanced technology solutions to make better and more informed decisions, facilitate compliance, reduce risk and improve operational efficiency. Headquartered in the United States, ArisGlobal® has regional offices in Europe, India and Japan. For more information, visit us at https://live-arisglobal.pantheonsite.io.