Case Studies: Examples:Regulatory Assessment and Validation


Regulatory Assessment and Validation

Customer: The client is a blue-chip large biopharmaceutical company with 1000’s of employees. It has multiple products that are already on the market and 10’s of therapeutic diagnostic products in development or clinical trials.

Problem: The client was dealing with  a large body of clinical data from multiple drugs across many countries.  This data was not available in an integrated manner and the challenge was to develop and an approach that would provide an integrated view into all the existing internal and external clinical data in real time. 

Solution: Tribiosys is currently managing the development of a critical, high visibility Knowledge Management (KM) application within the regulatory affairs group. The KM application will be rolled out to hundreds of users globally. The 21 CFR Part 11 compliant application will consolidate and secure regulatory information to eliminate repetitive, complicated searches for regulatory information. This application will support the product development lifecycle by providing targeted information to all personnel and establish compliance with electronic records management.
Tribiosys is managing the entire project from RFP management, vendor selection and finalization, design, development, testing, SOP development, validation, user training development and delivery, data loading and conversion and corporate rollout of the application to various US based and international divisions of the company. The KM application is being developed using state of the art Microsoft technology. Tribiosys is also coordinating the corporate IT initiatives towards the adoption of these new technologies. The architecture and technical infrastructure of this application will provide a sound foundation for future KM initiatives at the pharmaceutical company.
Tribiosys is managing a project team of 30 individuals and an extended project team of over 50 individuals and a multi-million dollar budget. 

Additional case studies -Regulatory Assessment and Validation

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