Clinical and Medical Affairs
CRO Support.
Setting up and actively managing CRO partnerships effectively. We assist pharmaceutical and medtech companies in selecting, onboarding, and managing Contract Research Organizations—from the RFP through to close-out.
What problems arise in CRO partnerships?
Clinical trials rarely fail due to a lack of CRO capacity, but often due to significant gaps in management and oversight:
- CROs are often selected based solely on price rather than on professional qualifications and a genuine fit for the study.
- Unclear governance structures lead to constant breakdowns in communication and critical delays.
- "Sponsor oversight" is too passive; operational issues are not escalated until very late in the process.
- Contractual provisions leave too much room for interpretation, which inevitably leads to dangerous "scope creep."
As a sponsor, do you have a structured CRO oversight system with clearly defined performance KPIs?
Our CRO support services.
We provide you with expert guidance in the selection process and ensure quality throughout the entire CRO partnership.
CRO Selection & Request for Proposal
Development of a structured RFP process with clear requirements profiles. In-depth market analysis of suitable CROs by indication, geography, and capacity. Evaluation of proposals and support during bidder presentations.
Governance Structure & Oversight Framework
Defining clear communication structures, escalation procedures, and reporting requirements. We implement our field-proven CRO oversight framework, which includes review meetings, KPI tracking, and structured issue logs.
Ongoing CRO Performance Management
Regular and objective performance evaluation of the CRO against defined KPIs (e.g., recruitment rate, data monitoring committee cycles, TMF quality, reporting timeliness). Early detection of deviations and active escalation management.
CRO Audit & Quality Review
Comprehensive sponsor audit of the CRO in accordance with ICH E6(R2): We evaluate internal processes, GCP compliance, and the actual quality of the study on-site. Reporting to the sponsor, including clear recommendations for action.
Frequently Asked Questions About CRO Support.
When is it worth hiring a CRO?
A CRO is essential when internal resources for study management, monitoring, or data management are lacking. It is also necessary for global or multicenter studies, for highly specialized indications where in-house expertise is lacking, or when very rapid study initiation requires external capacity.
What is sponsor oversight, and why is it important from a regulatory perspective?
According to ICH E6(R2), the sponsor remains fully responsible for the study’s GCP compliance even when the CRO is fully contracted. Sponsor oversight involves actively monitoring the CRO, conducting quality audits, tracking KPIs, and maintaining documented escalation processes. A lack of oversight is one of the most common GCP findings during regulatory inspections.
How do you choose the right CRO?
Key criteria include: experience in the specific indication, geographic reach, expertise in the relevant study phase, available capacity, a favorable price-performance ratio, and cultural fit. A structured RFP process that includes a capabilities assessment helps to make objective comparisons and minimize risks.
Can CRO contracts be renegotiated during the course of the study?
Yes, renegotiations are often possible—and even advisable—if the scope of the study has changed unexpectedly, milestones have not been met by the CRO, or general performance issues arise. ENTOURAGE actively supports you in preparing for and conducting such critical CRO contract negotiations.
Additional expertise in clinical trials.
Submit a project inquiry.
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