Welcome to the elderbrook solutions Academy!
As the independent training institute of elderbrook solutions, after our succesful first lunch webinar, we are thrilled to host the subsequent session.
elderbrook solutions brings deep, real-world expertise in clinical data management, biostatistics, and statistical programming. Our Academy is the vital channel through which we share this knowledge, driving meaningful impact and professional excellence across the industry.
Join us for this exclusive session to enhance your skill set and leverage our proven experience in digital solutions and specialized clinical research services.
Upcoming Event: Chain of Custody Under the Spotlight: How Sponsors Keep Control in a CRO–Subvendor World
In today’s outsourced clinical trial landscape, sponsors delegate tasks but retain full oversight responsibility across CROs and their subcontractors. This talk examines end-to-end chain-of-custody oversight challenges amid limited CRO transparency, dissecting recent inspection findings of inadequate sponsor control. Linking to ICH E6(R3), we cover risk-based strategies, KPIs, and sponsor access to subvendor details. Practical contract structuring and CRO oversight evidence will be shared.
The presentation will be followed by an interactive Panel Discussion, where you will have the opportunity to engage directly with our experts on these pressing industry topics
Speaker Spotlight: Dr. Christoph Ortland, CEO of Forschungsdock CRO
We are honored to welcome Dr. Christoph Ortland, the Chief Executive Officer at Forschungsdock CRO, to our Lunch Webinar as a speaker.
Dr. Christoph Ortland is the CEO and founder of Forschungsdock CRO GmbH, a contract research organization specializing in clinical development. With over 30 years of experience in clinical research, he started his career in 1993 at an international pharmaceutical company. He is also a GCP auditor, trainer, and consultant, focusing on supporting pharma, biotech, and medtech sponsors.
What to Expect? Our Agenda
Lunch Webinar – How Sponsors Keep Control in a CRO–Subvendor World
11:30 – Welcome and short introduction
11:35 – How Sponsors Keep Control in a CRO–Subvendor World – Dr. Christoph Ortland
- Setting the Scene: What “Chain of Custody” Really Means in Sponsor–CRO–Subvendor Models
- Where It Goes Wrong: Inspection Findings When Sponsors Cannot Demonstrate Full Oversight
- Expectations from ICH E6(R3): Transparency, Risk‑Based Oversight, and KPI Access for Sponsors
- Making the Middle Transparent: How CROs Should Evidence Oversight of Their Subcontractors
11:55 – Expert Discussion (Dr. Andrew Baxter, Dr. Max Horneck, Dr. Christoph Ortland)
Topics:
- Risk-based oversight in practice
- Contractual leverage vs. collaboration
- End-to-end SAE accountability
- Defining “adequate oversight”
12:15 – Farewell
