Subject: eTMF Sponsor Oversight | Webinar

This session will present insights gained from interviews with a set of experienced industry leaders.

Clinical Webinar

Sponsor Oversight and

the Role of eTMF

Wednesday, July 20, 11am EDT

Learn how your industry colleagues are conducting TMF oversight and overcoming common challenges.


Sponsor oversight of TMFs is a regulatory requirement whether trials are conducted by the sponsor, a CRO, or in a mixed model. However, Health Authorities are not explicit about the requirements for conducting and documenting sponsor oversight.


This session will present insights gained from interviews with a set of experienced industry leaders, including their oversight philosophy, tools and practices.

Speaker

Kathie Clark

Product Director, CTMS and eTMF

Email: kclark@ennov.com

Mobile: +1 (267) 560-6971

Visit us: https://www.ennov.com

Kathie is an expert in content management for the pharmaceutical industry, with over 20 years of experience implementing enterprise-level, validated solutions for major life sciences companies in the US, Europe, Japan and Israel.


In her prior positions, Kathie was responsible for the design and development of a number of document management products. She is the author of many white papers and blog postings and is a regular presenter at industry conferences. Kathie is also a member of the DIA TMF Reference Model steering committee.

 

Ennov develops innovative, powerful and easy-to-use software for document and process management. Ennov has specialized its software to meet the specific needs of the health and life sciences sectors: Quality, Pharmacovigilance, Clinical Studies and Regulatory Affairs.