Trial Oversight Spotlight #5: Christoph Ortland
In this episode:
Tom interviews Christoph Ortland, Founder and CEO of FD CRO, to discuss the unique challenges small sponsors face and how boutique CROs can provide tailored solutions to meet industry standards. Christoph shares invaluable insights on regulatory compliance, quality management, risk mitigation, and the growing importance of digital tools in clinical trial oversight.
Key points:
- Navigating regulatory compliance for small sponsors
- Scaling processes to meet evolving requirements
- Effective risk management and vendor oversight strategies
- Supporting quality assurance in small-scale operations
- The critical role of electronic tools in trial management
Time stamps:
- – Christoph Intro
- – Regulatory Compliance for Small Sponsors
- – Key Aspect of Working with Small Sponsors
- – Scaling Regulatory Compliance in Small Sponsors
- – Risk Management and Vendor Oversight
- – Supporting Quality Management in Small Sponsors
- – The Need for Electronic Tools
- – 3 Top Tips for Small Sponsor Quality and Compliance
Guest Bio
Christoph Ortland
Founder and CEO, PHARMExcel
Christoph Ortland, CEO and Founder of FD CRO, has been a key contributor in clinical development since 1993 and leads Forschungsdock CRO with a focus on precision, quality, and people-centered project management.
His experience as a GCP auditor, trainer, and consultant has made him a trusted partner for small sponsors navigating complex regulatory requirements and risk management.
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.