The Client Profile
Founded in 1995 and based in South San Francisco, FibroGen is a biotechnology company that discovers, develops, and commercializes therapeutics that stop fibrosis, or pathological scarring.

The Business Problem
The Food and Drug Administration (FDA) requires that all biotechnology companies produce and maintain detailed records of every test, process, and procedure involved in researching, developing, manufacturing, and marketing products. FibroGen needed to ensure that all its regulated clinical processes and procedures were documented and in full regulatory compliance.

The TechProse Solution
TechProse completed a Needs Assessment of the current status of FibroGen's clinical processes and procedures. TechProse held in-depth interviews with a FibroGen medical writer, clinical and regulatory affairs personnel, and document control staff regarding their experiences with training, development, approval, and storage processes and procedures. The final report summarized recommendations for documentation and training process redesign, content development, and training implementation. TechProse then worked with the Clinical department at FibroGen to develop templates and create procedure documentation, as well as deliver analysis and recommendations for updating departmental processes.