Trial Master File (TMF) management is a challenge from compliance, quality and efficiency perspectives. Content requirements are driven by ICH GCP, analysis of regulations, and business process practices. The challenge increases when working with CROs, and in partnerships, mergers and acquisitions. In response, an industry collaborative initiative under the auspices of the DIA released the TMF Reference Model V1.0 in June 2011, and V2.0 was released in June 2012. Whether you operate with paper or electronic TMF, using the model will help improve standardization and interoperability.
Join Paragon Solutions for this complimentary, 30 minute webinar to learn practical tips on the evaluation and application of the model, and additional insights on content considerations that can positively impact your TMF.