Emerging clinical trial sponsors often rely on Clinical Research Organizations (CROs) or other vendors for Trial Master File (TMF) management but remain responsible for oversight and compliance. Many small biotech sponsors underestimate the importance of early TMF oversight, leading to costly remediation at trial closeout.

This presentation clarifies the distinction between TMF management and oversight while offering practical ways to align sponsor-CRO expectations. From Request for Proposal (RFP) to Archive, attendees will learn the value of integrating TMF requirements into study risk assessments, contracts, budgets, procedures, and governance reviews to prevent compliance issues, budget renegotiations, and relationship conflicts.

By proactively assessing TMF needs, sponsors and CROs can reduce risks, ensure audit readiness, and avoid last-minute resource burdens.

This Webinar Will Offer Practical Guidance:

• How to integrate TMF oversight and governance across Sponsor and CRO.
• How to avoid compliance pitfalls and costly remediation at trial closeout.
• How to ensure audit readiness by proactively addressing TMF needs.
• How to minimize budget renegotiations and relationship conflicts with CROs.
• How to reduce last-minute resource burdens through early TMF planning.