Articles by Ken Keefer

1. ICH E6(R3) And Defining What Is Critical To TMF Quality 4/9/2024

   By 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).

2. Who Are Your TMF Customers? The Key To Greater Trial Efficiency & Quality 12/12/2023

   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.

3. Designing Quality Into Your TMF: ICH E6(R3) And Advancing Trial Efficiency 7/17/2023

   The May release of the International Council for Harmonization (ICH) draft guidance E6(R3) for public review and comment has inspired optimism that its implementation could lead to more efficient trials.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?

4. TMF Reference Model Affiliation With CDISC Could Improve TMF Interoperability 3/20/2023

   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.