Case Study: Global Phase 2 Drug Delivery in Advanced Colorectal Cancer

A global Phase 2 study evaluated an investigational drug delivered directly to liver metastases in patients with advanced colorectal cancer. The drug delivery system required up to four clinical subspecialists per procedure, specialized equipment at every participating site, and cross-border shipment of devices and materials across the United States and Europe.

Many sites were unfamiliar with the delivery system, which meant extensive training and readiness assessments before a single patient could be treated. Limited upfront feasibility contributed to extended activation timelines, and Precision's team spent much of the early study identifying operational gaps and actively supporting site readiness through start-up and beyond.

Study Overview

** Study in progress

The sponsor developed a commercially approved hepatic delivery system that uses percutaneous hepatic perfusion to deliver an investigational drug directly to liver metastases, filtering the blood before it returns to systemic circulation. Each procedure requires coordination of up to four clinical subspecialists, specialized extracorporeal equipment at the site, and infrastructure that most oncology centers do not maintain by default. This is closer to a surgical intervention than a standard infusion.

When Precision was engaged to manage global site start-up and execution, the sponsor had already identified sites from its commercial network. These were institutions using the delivery system for approved indications, and the rationale was sound: start with sites that know the technology, reduce training burden, and accelerate activation. In practice, commercial familiarity with the device did not reliably translate to clinical trial readiness.

"We recognized early that commercial experience with the system and clinical trial readiness are two very different things," says Tai Bibbs, Director of Project Management and the study's DPM. "The sites knew the procedure, but the infrastructure around it, the committees, the staffing models, the regulatory requirements, none of that had been assessed."

Formal feasibility had not been conducted prior to site selection. The sponsor's approach relied on PI conversations and commercial relationships, and investigators confirmed interest and access to subspecialists. What those conversations did not surface were the operational realities underneath: contract staffing arrangements for interventional radiologists, committee review timelines, equipment procurement requirements, and the true cost of retaining subspecialists for a clinical study. Precision's startup team inherited every one of those gaps as a real-time discovery.

Stabilizing Execution Across Borders Without a Feasibility Foundation

The scope of the challenge became clear almost immediately. Sites were being handed over for activation without a final site list, without structured readiness assessments, and without visibility into the institutional requirements that would determine activation timelines. The team needed to simultaneously identify operational gaps, coordinate subspecialist access, manage cross-border device logistics, and train device-naive sites, all while maintaining sponsor alignment and investigator engagement.

"Investigator enthusiasm is valuable, but it is not a proxy for site readiness," Bibbs explains. "A PI may confirm access to an interventional radiologist without knowing that the individual is on a contract arrangement. When the site then needs to add retention costs to the study budget, the sponsor is facing an expense that structured feasibility would have identified months earlier."

The drug delivery system compounded these challenges. The extracorporeal machine required at each site meant procurement, shipping, customs clearance, and installation before a single patient could be screened. Across Western and Eastern Europe, each country introduced its own import requirements, tax structures, and regulatory expectations for medical devices in clinical research. Country-specific requirements, from tax stamps on imported equipment to specialized import documentation, had to be identified and managed individually. Equipment and investigational product movement across borders added regulatory complexity that does not appear in any standard site activation checklist.

Several of the approximately 30 sites were also unfamiliar with the delivery system. Device-naive sites required extensive in person hands-on training, provided by the Sponsor, that extended well beyond standard site initiation. Each site needed to demonstrate procedural competency across the full subspecialist chain, and the coordination reached into data capture as well. Research coordinators would not be present during the procedure, so the team had to establish pathways for clinical data to flow from the treatment team to the staff responsible for EDC entry. That handoff is invisible in most trial designs but represented a meaningful operational burden in this one.

Moments That Mattered

Building Readiness Through Strategic Decisions and Sustained Engagement

Leveraging the Precision Site Network

One of the earliest strategic decisions was recommending the first site to activate. The one we selected is part of Precision's Site Network (PSN), and the investigator was already trained on the drug delivery system. The sponsor had preferred to begin with their commercial sites, but the PSN advantage was clear: known infrastructure, established committee timelines, and existing procedural competency. Activating this site first gave the broader network an operational baseline to work from. “We recommended starting with a site where we already understood the infrastructure, and the investigator had hands-on experience with the system," Bibbs says. "That allowed us to establish a working model before scaling to sites that required more preparation."

Driving Site Readiness Through Startup Engagement

The startup team conducted site engagement calls that mapped out institutional review committees, identified additional approvals each site required, and established agreed-upon timelines for every activation milestone. The discipline was in holding sites to those timelines rather than allowing delays to compound without accountability. Where additional training was needed, the team coordinated hands-on preparation to ensure procedural competency before enrollment could begin.

Sustaining Investigator Commitment

Monthly PI calls served a dual purpose: tracking enrollment progress and creating a forum where investigators could share challenges and learn from what was working at other sites. In a study with extended activation timelines and a demanding procedure, investigator disengagement is a real risk.

"Regular touchpoints with investigators are essential in complex studies," Bibbs says. "It reinforces scientific engagement and gives investigators the information they need to confidently approach patient identification. Plus, when sites hear that other centers are making progress, it reinforces commitment across the network."

Navigating Vendor Architecture

The sponsor chose to contract with the EDC vendor directly to do the EDC build rather than include this as part of our CRO scope. This decoupling created multiple inefficiencies throughout the process which led to re-work and delays to EDC go-live.

The vendor could build to specification but lacked the regulatory context and quality frameworks that a CRO brings to data management. "A technology vendor builds what you ask for," Bibbs explains. "A CRO builds what the regulations require, even when the specification doesn't explicitly address it. That distinction becomes critical during data cleaning." The team navigated the gap, but the experience informed clear recommendations for how critical data functions should be managed in subsequent studies.

Lessons Learned

A Partnership That Grew Through Complexity

The sponsor awarded a second study during the first. Each engagement expanded Precision's scope. Both opportunities include full medical monitoring, a function the sponsor had previously retained but recognized they did not have the bandwidth to manage as enrollment scaled. By that point, the sponsor also agreed to formal feasibility, a structural change that Bibbs had advocated for based on the evidence from the first two studies.

"After two studies, the data was clear," Bibbs says. "We were able to demonstrate exactly where limited feasibility had contributed to delays and additional costs. When we recommended formal feasibility for the other programs, the sponsor understood why."

The decision to expand scope across consecutive studies reflects more than satisfaction with deliverables. It reflects confidence in how the team operated when things were difficult. Problems were surfaced directly, recommendations were grounded in operational evidence, and when structural changes were needed, the conversation happened without hedging.

This study reinforces several principles that are easy to acknowledge in theory but difficult to execute in practice. Feasibility must evaluate infrastructure, not just investigator interest. Drug delivery trials carry an operational burden that standard benchmarks do not account for, and procedural complexity must be reflected in timelines and budgets from the start. Site experience with the technology accelerates activation, but where device-naive sites are necessary, training must be planned as a sustained workstream. Cross-border logistics for equipment and investigational product require dedicated planning as a parallel lane, not a downstream task. And frequent, substantive communication with investigators and sites is what sustains progress when complexity creates friction.

Precision for Medicine brings this same operational rigor and collaborative approach to every drug delivery, combination, and complex global trial. If you're navigating a program where the science demands more than a standard playbook, our team can help.

Let's talk about how we can support your next study.