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German Pharma Company Selects Generis’ CARA Life Sciences Platform To Unify Their Clinical Processes

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Generis, provider of the CARA Life Sciences Platform for managing the business processes, data, and content of the entire product development lifecycle, has announced that German Pharma company Cheplapharm has selected the CARA Life Science Platform to standardise and unify their Regulatory, RIM, Quality and Labelling processes across departmental boundaries. 

Cheplapharm were looking for a solution to enable them to move away from manual data processes and using multiple separate systems including Excel, which lacked the necessary security and traceability to remain compliant and provide enterprise overview. Cheplapharm wanted a solution which would consolidate multiple processes with automations, workflows, and integrated notifications so that users could dynamically manage information for their individual processes but within the context of the entire R&D data. 

CARA fulfilled these requirements with its single structured data lake which spans across Regulatory, Quality, Clinical, Safety and other enterprise business areas. In addition, CARA’s authorisation concept allows controlled access, including collaboration with external parties and different permissions for read-only and full users. CARA Life Sciences Platform also offered a solution for IDMP / SPOR to enable exchange of medicinal product information with Health Authorities in a robust and consistent manner. 

Commenting on the choice of Generis’ CARA Life Science Platform, Ricardo Kressin, Director of IT at Cheplapharm said, ‘Connectivity and harmonisation were both key driving factors behind our decision to choose the CARA Life Sciences Platform to consolidate our processes. The single information lake ensures that data is entered only once and re-used, which then has the major benefits of being able to use that data for traceability and impact analysis across the R&D process. This allows Cheplapharm to see how changing any part of our enterprise information impacts any other part, at the click of a button, which also will significantly reduce the effort and cost of making ongoing updates related to our products, suppliers and patient well-being”.

One of the key drivers at the heart of this project was effective master data management. The CARA Life Sciences Platform will enable Cheplapharm to unify RIMS, IDMP, Quality, SOP, PV Cases and Complaints, and more, on one platform, based on a single information lake, meaning users input the information once and can easily re-use it, with no disconnected siloes which restrict collaboration. 

James Kelleher, CEO of Generis commented “We are delighted that Cheplapharm are joining the growing CARA customer community. They share our vision for a new era of data-driven processes in a single platform, enabling accelerated speed to market, with strict control of regulatory and data compliance requirements – helping provide value to enhance the support of patient health.”