Trial Oversight Spotlight #11: Matthew & Stephen, part 2
In this episode:
The conversation continues with complexities of governance, vendor management, and risk management in clinical trials. Matt and Steve discuss the importance of understanding governance as it relates to oversight and management, the critical elements of vendor selection and off-boarding, and the necessity of building strong relationships with CROs. They emphasise the importance of a proactive approach to risk management. The discussion highlights the need for clear communication, documentation, and a balanced approach to ensure successful trial outcomes.
Key points:
- Governance in clinical trials is about oversight and management
- Building trust and transparency with CROs is essential
- Vendor selection should be a thorough and well-planned process
- Offboarding and closeouts are critical to trial success
- Technology can enhance vendor management but should not replace relationships
- Risk management should be integrated from the start of the trial process
- Metrics should be meaningful and not just for the sake of data collection
Time stamps:
- – Introduction and overview of the conversation
- – Understanding governance in vendor management
- – The importance of vendor off-boarding and closeouts
- – Lessons learned and continuous improvement
- – Future trends in vendor management
Guest Bio
Matthew Hersch & Stephen Crow
Founders of BlueGreen Clinical
With 20 years in Clinical Operations at a pioneering cannabinoid biotech, Matthew Hersch and Stephen Crow guided its growth from startup to mid-sized pharma. Their hands-on experience spans trial management, CRO oversight, team building, and GCP inspections.
In 2023, they founded BlueGreen Clinical to help biotechs build strong Clinical Operations foundations, sharing hard-won insights from their journey.
Host Bio
Tom is running the Trial Oversight Spotlight Interview Series where he meets with a variety of colleagues working in clinical research. They discuss a selection of the most important topics and decisions that are currently being navigated by all types of organisations delivering research.
Tom has spent over a decade in Clinical Trials Operations and Quality Assurance and has experienced the impact that suboptimal vendor oversight and vendor non-compliance can have on the quality of clinical trials. Mayet is the solution to fix this.