I have recently published a peer-reviewed paper called “Optimize Your eTMF Strategy”, that you can read or download on the Journal for Clinical Studies (Volume 11, Issue 11).
I wanted to give you in this blog a short glimpse on the main points addressed in this paper.
The TMF plays an essential in ensuring data integrity and human safety in clinical trials.
Having an optimized eTMF strategy is an excellent investment as it enables to solve the challenge of maintaining a cost-effective TMF solution. Such a strategy should ensure regulatory compliance, quality, and cost-effectiveness.
The eTMF operates in a complex environment:
- Numerous stakeholders that range from internal departments (clinical operations, regulatory, data management) to external partners (CROs, committees, ethics boards, and labs) and regulators.
- Activities are controlled by a quality management system and require evidence that defined processes were followed.
- Needs grow as the number and size of an organization’s clinical trials increase.
The eTMF strategy has to take into account the following aspects:
- Regulatory Compliance: Every decision made in an eTMF strategy should include a consideration of how it would be viewed by a TMF inspector. This includes careful naming and organization of documents, facilitating document navigation and search, determining which paper documents can be destroyed and how to replace them by their electronic versions, etc…
- Quality: adopting a risk-based approach, built on quality by design (QbD), and the management of critical quality attributes.
- Cost-effectiveness, which is better achieved by identifying non-value-added activities, promoting task efficiency (mainly thanks to a well designed eTMF system), implementing task automation whenever possible thanks to the progress of artificial intelligence.
I hope this introduction will convince you to read the complete article on the Journal for Clinical Studies.
Chet Shemanski is a proven business and information technology professional with extensive experience serving the healthcare and global life sciences industries. He has specific expertise in software product commercialization including product management, product marketing, solution strategy, and alliance management. Chet is a subject matter expert in eClinical and eRegulatory technologies, the author of industry journal articles and a speaker at industry conferences.