Excelya at COG CRO Summit Europe 2026: Key Clinical Operations Insights

Sponsor and CRO partnerships need workable governance

The discussions on partnership, bid defense and budgeting highlighted the need to carry selection-stage expectations into study delivery. Sponsors and CROs benefit from transparent assumptions behind timelines and costs, agreed responsibilities and an escalation route that works when performance falls short. A recovery discussion should identify the cause, the decision required and the person responsible for the next action.

Early site input makes feasibility more credible

Feasibility should examine how eligible patients reach a site and what may prevent them from participating. Local standard of care, competing studies, visit burden and site staffing all help explain whether an enrolment estimate is realistic. Feedback is most useful while protocol and country plans can still change.

Bringing investigators and site teams into those discussions early can expose restrictive criteria, procedures that conflict with routine care or hospital steps missing from the activation plan. Study teams can then refine recruitment assumptions and address the practical constraints before they affect a milestone.

Centralized eligibility review supports prevention before enrolment

One of the speaker presented their centralized eligibility review as an approach to preventing enrolment-related protocol deviations while maintaining recruitment timelines. For complex criteria, a prospective review before enrolment or randomization, as appropriate, offers a chance to resolve uncertainty before a participant proceeds. Retrospective detection during monitoring remains valuable, but it occurs after the inclusion decision has been made.

Our operational questions also concerned the data supporting the review. If a separate platform is used, how is its information reconciled with the electronic data capture (EDC) system? Who checks missing or incorrectly transcribed information, and when should the medical monitor be consulted? These responsibilities should be defined in the workflow and training before screening begins. Repeated queries can also reveal a need to clarify the protocol or site guidance.

Oversight should cover the full delivery network

The session on extended delivery networks examined CRO oversight of specialist suppliers, functional providers and sub-CROs. Each handoff needs a clear owner and a route for raising concerns. A sponsor should be able to understand how the lead CRO checks subcontracted activities, what happens when a supplier issue affects quality or timelines and what are the mitigation plans to anticipate turn over risks.

Operationally, this means mapping dependencies before critical work begins and following the points of risk throughout delivery. Reporting should make emerging issues visible and support a timely response across organizations and throughout contract duration.

AI should address a defined study need

Among the innovations presented at the summit was an AI-first approach to trial design. The Aika platform (an end-to-end clinical trial AI intelligence platform) is described by its developer as supporting protocol development and feasibility. The operational question is whether such tools help teams challenge protocol assumptions and complexity against available evidence and the likely patient pool early enough to improve the plan.

The organizer’s account identifies recruitment and retention as recurring priorities, alongside concerns about regulation and cost relative to value.

For an eligibility workflow, AI could be explored to flag missing evidence or inconsistent entries. That possibility should be evaluated separately from the centralized review approach presented at the summit. Technology can support the review process while qualified clinical staff remain accountable for interpreting the evidence.

Risk signals need a clear response pathway

Risk-based quality management (RBQM) featured in discussions about identifying issues earlier. An indicator becomes useful when teams know who will review it, what warrants investigation and how the resulting action will be recorded. Oversight of third-party tools should cover their intended use and the handoff from a system-generated signal to an accountable study team member.

European trial attractiveness also depends on site execution

The discussion on Europe’s position in global clinical research extended beyond regulatory pathways. Contract templates, hospital procedures, budget negotiation and data protection work can influence when a site is ready to enroll. Study teams need a view of the complete start-up timeline, including activities that can progress in parallel and local dependencies that require early attention.