In the clinical development phase of clinical trials the pharmaceutical industry maintains a trial master file (TMF) comprised of thousands of pages of regulatory documents required for each clinical trial. For the majority of clinical trials, clinical trial regulatory documents are primarily paper documents captured centrally in physical file cabinets. These paper-based TMFs are a centralized set of central documents that typically are used to support and comply with applicable regulatory requirements and Good Clinical Practices (GCP).
With the industry move to an electronic clinical management system more companies are also making the move from TMF to eTMF. An eTMF system is used as a content management system as well as a storage and filing component for the TMF. After implementing an eTMF system all stakeholders involved in the clinical trial, including government/regulatory agencies, sponsors, investigators and clinical research organization can both online and offline access the clinical trial eTMF archive. This allows for a higher quality level in the document review, compliance and audit, quality control and trial oversight.
This conference is designed to bring to light the significant benefits and challenges that occur during the industry move from TMF to eTMF. During this two-day program we will explore the reasons to make the change, as well as learn first hand from the investigators, pharma companies, and all other stakeholders on how the eTMF integration is going as well as explore the management benefits of the eTMF system. In addition, this event will provide opportunities for industry alignment across all contributors and stakeholders including sponsors, regulators, CROs and project teams. The major theme throughout the event will be the practical application and usage of eTMF system, filing, and data storage.
“I was very pleased with the content and presentations of materials”
“This was a wonderful informational conference with experience speakers”
“Very informative conference”
“I was very impressed with the content and presentations”
“At this evenet I was able to learn a lot about eTMF platforms and was than able to share new information with my team”
This conference is designed for representatives from pharmaceutical, biotech, medical device and clinical research companies with responsibilities in the following areas: