Regulators worldwide require Sponsor companies to assemble a comprehensive Trial Master File during clinical trials. This means filing and maintaining hundreds of thousands of clinical documentation. This is important both for the patient and for the sponsor companies to ensure they are ready for inspection and that GCP guidelines are being followed.
In recent years, there has been much discussion on which documents should be included in TMF and how to make the switch to an eTMF system; which could result in greater ease of archiving for TMF professionals. Implementing eTMF can be costly and training employees can be difficult, however through eTMF you can ensure real time monitoring of data to ensure data. This will result in better management of CRO partners and ease the inspection process for sponsor companies.
At ExL Pharma’s 4th Trial Master File Summit, TMF experts will discuss best practices for developing, managing, and monitoring a TMF process that is regulatory compliant for audits and inspections. TMF Process Owners, Quality Assurance, Clinical, Regulatory, and Information Technology professionals who are responsible for TMF will share insights and best practices to facilitate successful TMF management.