Activating sites for a global Phase 3 oncology trial

The Challenge

Patients with aggressive gastrointestinal cancers have few treatment options. For many, a clinical trial is their best path forward. Every week a site isn’t ready to enroll is a week those patients can’t access a potentially life-changing therapy.

This Phase 3 trial in a hard-to-treat gastrointestinal cancer spanned multiple countries, each with its own ethics committee requirements, regulatory frameworks, and document standards. Sites needed to clear feasibility, collect essential documents, negotiate informed consent forms (ICFs), obtain ethics approvals, and confirm investigational medicinal product (IMP) readiness before they could screen a single patient. Coordinating all of that across countries, languages, and time zones made activation a significant operational challenge.

What We Did

We led site-level startup from feasibility through activation. That meant owning the full scope of site readiness for each assigned location:

• Collected and reviewed essential documents against sponsor requirements and ICH-GCP standards
• Negotiated ICFs with sites, balancing sponsor language requirements with local ethics committee expectations
• Prepared and tracked IRB and ethics committee (EC) submissions, including responses to questions and conditions of approval
• Monitored ancillary approvals: radiation safety, biosafety, pharmacy, and lab certifications
• Confirmed IMP release readiness and coordinated shipment timing with site activation dates

We served as the site-facing escalation lead, working across Clinical Operations, Regulatory Affairs, Legal and Contracts, Finance, and IT to resolve issues that could delay activation. When a contract negotiation stalled or a regulatory question sat unanswered, we identified the block and pushed it to the right person. That cross-functional role was critical in a multi-country program where no single team had visibility into every dependency.

We also built tracking dashboards for leadership so they could see real-time activation status by country and site. These dashboards surfaced risks early and gave program leads the data they needed to make resourcing decisions. Each site had a clear activation timeline with milestone dates, so leadership could spot a slipping site before it became a problem.

The Result

Clear ownership of each site’s activation path meant fewer handoff gaps and faster issue resolution. Sites moved through startup with a predictable sequence of milestones rather than an ad hoc collection of tasks.

The documentation we maintained was inspection-ready throughout the process. The site-readiness checklists, regulatory review logs, and escalation pathways we developed for this program were later picked up by other studies at the sponsor, but the point at the time was simpler: sites opened in a known order, leadership could see which ones were at risk, and patients with few options got access to the trial sooner.