In 2019, a large, international Phase III study of a treatment for parainfluenza in immunocompromised subjects was underway in the U.S. Unfortunately the study’s sponsor, a small, U.S.-based biopharmaceutical company, was displeased with the existing CRO’s conduct of the trial. The sponsor asked Westat to take over the study’s management – emphasizing its need for an experienced, responsive, flexible project team that could offer creative solutions to accelerate start-up activities on a short timeline. In reality, the study needed to be rescued.

Rising to the Challenge

Immediately, we selected key senior staff to manage the transition and meet with the sponsor to discuss our detailed transition plan. The strategy included using our cost-effective, integrated web-based system to streamline processes and reduce the burden on both sites and staff.

With project management tools and our proprietary standard operating procedures (SOPs) in place, we accomplished the smooth transfer of multiple subcontractors, study materials, and services in just six weeks. There was minimal impact to the project schedule or budget, little burden to participating sites, and no risk to subjects’ safety.

Engaging the Sites with Innovative Resources

To keep the sites engaged both during and after the transition, and especially during COVID-19 when recruitment was low, we added a clinical trial educator (CTE). The CTE supported communications, identified barriers to enrollment, and reinforced and provided specially focused trainings to clinical site staff and large teams of respiratory therapists.

Identifying Areas for Improvement

To pinpoint areas needing improvement, we conducted a gap analysis of the existing study materials and systems and adapted many of the prior CRO’s templates and project plans to accelerate enrollment. We ensured electronic case report forms were Clinical Data Interchange Standards Consortium (CDISC)-compliant and streamlined for data entry at the site and replaced the existing Interactive Web Response System (IWRS) vendor with one aligned with our high-quality standards. When concerns surfaced, we immediately discussed them with the sponsor.

Delivering a Successful Study

For the European Union (EU) study, 19 sites in six countries had been previously selected, but progress was otherwise at a standstill. We promptly leveraged existing partnerships with regulatory and data protection subcontractors who had solid EU experience and presence. With their expertise and our oversight, we collaboratively worked to progress the study in the EU and within three months were able to begin submitting applications for regulatory approvals.