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About Keefer Consulting

Ken Keefer managed strategic information systems planning projects for Ernst & Young before founding Keefer Consulting in 1989. He had worked previously for a Fortune 500 manufacturer and several other consulting firms as project manager, business analyst, and system architect.

Keefer Consulting Inc. formed as a Pennsylvania corporation in 1991. Ken developed and delivered training in system development methodologies and modeling tools to DuPont, Philadelphia Electric, SeaLand, Betz Labs, and other companies. His focus on the pharmaceutical industry began in 1997 while developing a customer model for a major pharmaceutical manufacturer. Keefer Consulting has since focused on helping growing biopharmaceutical companies improve R&D productivity and compliance through effective management of clinical and regulatory data.

Ken continued to expand his experience in analyzing business needs, facilitating collaboration across organizational units, and planning and executing projects. His leadership helped enhance the efficiency of R&D and commercial operations at Merck, Pfizer, and GSK. He served as project manager in the development of the eTMF Exchange Mechanism Standard, Version 1.0 for the TMF Reference Model in 2018.

Ken holds a MBA from Temple University and a post-graduate Certificate in Pharmaceutical and Healthcare Business from the University of the Sciences. He is recognized as a Certified Computing Professional (CCP) by Institute for Certification of Computing Professionals and as a Project Management Professional (PMP) by Project Management Institute. He writes about clinical and regulatory data topics and has spoken at several DIA conferences about the TMF Reference Model Exchange Mechanism Standard. You may contact Ken at 215-462-1601 or kkeefer@keeferconsulting.com, or book a conversation online at Schedule a 15-minute call