This whitepaper examines the evolving landscape of Trial Master Files (TMFs) considering the European Union Clinical Trial Regulation (EU CTR). It explores the critical role of TMFs in clinical trials, highlighting the significant changes brought about by the EU CTR implementation. The paper discusses the challenges and opportunities presented by these Regulatory shifts, offering insights into best practices for TMF management in the pre- and post-EU CTR eras. By analyzing the impact on document management, inspection readiness, and overall trial efficiency, this whitepaper provides valuable guidance for sponsors, CROs, and other stakeholders in adapting to the new Regulatory environment.
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