In the rapidly evolving landscape of clinical research, maintaining effective oversight is paramount for sponsors, yet numerous misconceptions persist that can hinder the success and integrity of clinical trials.
Topics include:
The Real Scope of Sponsor Responsibility: Why sponsors must stay actively involved in oversight, even when working with CROs.
Ensuring Data Integrity in Clinical Trials: How missing documentation and weak sample tracking can lead to inspection risks and delays.
Effective CRO Management Strategies: The role of clear contracts, defined responsibilities, and escalation pathways in maintaining control.
Mastering Proper Documentation Practices: Why thorough training records and site documentation are essential for compliance.
Misunderstood Aspects of Risk Management: How a risk-based approach helps prevent protocol deviations and improves trial efficiency.