Ken Keefer
Ken Keefer founded Keefer Consulting Inc. early in his career with a commitment to helping clients develop innovative computer-based solutions to business problems. Today, he applies his experience to transforming clinical operations through improved system interoperability and process efficiency. He envisions a world in which clinical operations can share information seamlessly with regulators, service providers, and partners through common standards and processes. The ultimate goal is to achieve positive outcomes for patients quickly and cost-effectively.
Ken holds an MBA from Temple University and a post-graduate certificate in pharmaceutical and healthcare business from the University of the Sciences in Philadelphia. Ken can be reached at kkeefer@keeferconsulting.com.
ARTICLES BY KEN KEEFER
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![standardization certification compliance-GettyImages-1733514056]( "ICH E6(R3) And Defining What Is Critical To TMF Quality")
4/9/2024By applying Quality by Design to clinical trials, sponsor companies can rise to meet the elevated role and importance of the TMF in the face of ICH E6 (RF3).
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Who Are Your TMF Customers? The Key To Greater Trial Efficiency & Quality12/12/2023
Could your director of clinical operations or TMF manager identify all customers of the TMF? Perhaps not. Learn why knowing all customers is so important to efficient, high-quality trials.
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Designing Quality Into Your TMF: ICH E6(R3) And Advancing Trial Efficiency7/17/2023
The May release of the International Council for Harmonization (ICH) draft guidance E6(R3) for public review and comment has inspired optimism that its implementation could lead to more efficient trials. Could implementation also improve trial master file (TMF) quality in support of greater efficiency?
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TMF Reference Model Affiliation With CDISC Could Improve TMF Interoperability3/20/2023
There is a growing desire within the clinical trials industry for better data integration — not just to help regulators, but also to help sponsors manage trials more effectively. The recent affiliation of the TMF Reference Model with the Clinical Data Interchange Standards Consortium (CDISC) may become key to making this possible.