London, UK – July 18th, 2022 - Generis, creator of CARA, the cloud data, content, and business process management platform, today announced that a top 10 European biopharma company has successfully implemented its CARA™ Life Sciences Platform to streamline supply chain safety management.
CARA will help transform the way the company manages thousands of safety data exchange agreements (SDEAs), as well as periodic safety reporting, as part of its pharmacovigilance (PV) obligations. Up to now, the company has managed its SDEAs on a largely manual basis, distributing contracts/safety agreements with external parties via email from company systems.
As well as lacking efficiency and easy traceability, this ad-hoc approach resulted in drafted documents and distribution rules residing in non-controlled systems or spreadsheets. This caused problems when creating periodic safety update reports (PSURs), a process that depended on specific users being available to find the content needed.
With CARA™ Life Sciences Platform, the company will be able to hold SDEAs centrally, access them readily, and automatically distribute safety reports (PSURs, DSURs and more) in accordance with given parameters (e.g. issue X safety document to Y supplier each quarter). The company can choose to share the relevant documents automatically or allow approved users to self-serve and access the content they need on demand. When they log in, they will also have visibility of whatever actions are required, and which actions are outstanding.
As well as streamlining PV contracts, SDEA management and reporting, the new set-up will provide a clear overview of the status of each partner and full traceability across documents and their status.
All of this will boost efficiency and compliance. Although the company uses a different high-profile software brand to manage some of its content, the system was essentially a passive repository, and lacked the flexibility to adapt to the business’s needs or support process automation.
“CARA, on the other hand, can action everything and issue timely notifications,” James Kelleher, CEO of Generis, said. “When it comes to the setup of workflows, our platform is highly flexible. It is very smart too: CARA ‘listens’ to external systems and, based on the metadata it finds, it knows what data or content to pull into a particular workflow.”
Generis is a UK-headquartered developer of world-class data, content and business process management for regulated industries globally.
60% of the top 20 life sciences companies rely on Generis’ flagship CARA™ Life Science Platform, including AbbVie, UCB, Biogen, Gilead, Bayer, Pfizer, and Merck KGaA.
Today Generis serves more than 750,000 users worldwide, across use cases ranging from RIM, Regulatory / R&D and Safety use cases to Clinical, Non-clinical, Quality GxP, CMC, Pharmacovigilance, Medical Information / Medical Affairs applications and more. More at generiscorp.com