Ennov is pleased to announce its participation and sponsorship at the 10th edition of the AFCROs (French Association of CROs) Clinical Research Day being held at the Hyatt Regency Etoile in Paris, France on March 17, 2022.
For more than 10 years, the AFCROs has been organizing the Clinical Research Day, bringing together approximately 350 participants from industry, academia, physicians, patients and service providers.
Ennov will be sponsoring a workshop, led by Ennov’s own Kathie Clark:
eTMF for Risk Management and Regulatory Compliance
Health Authorities require that a Trial Master File contain documents that allow the conduct of the clinical trial, the integrity of the trial data and the compliance of the trial with GCP to be evaluated. However, organizations often fail to meet the expectations of Health Authorities as TMF-related inspection findings are common. This session will examine how use of an electronic TMF can assist with regulatory compliance, track and manage risk, and help to prepare for audits and inspections.
Kathie Clark is an expert in the field of content management for the pharmaceutical industry, with over 20 years of experience implementing enterprise-level validated solutions for leading life science companies in the US, Europe, Japan and Israel. She specializes in document management, quality management systems and electronic submissions. Previously, Kathie was responsible for the design and development of a number of life sciences document management products including NextDocs and FirstDoc solutions, Wingspan eTMF, Wingspan eREG and IQVIA ePromo.
Kathie is also the author of numerous white papers, blog articles, conference presentations, webinars, and is a member of the TMF Reference Model Steering Committee.Questions? Contact us about our Clinical software suite that covers EDC, RTSM, eTMF, CTMS, and more.
