CASE STUDY: Rescuing Site Relationships
Background
Executive Summary
- Therapeutic Area: Multiple Sclerosis (MS)
- Phase: Phase II/III
- Geography: North America (with European expansion)
- Situation: Site disengagement and increasing operational pressure led to the disengagement of North American sites, halting patient recruitment and jeopardizing the integrity of data from the trial.
- Outcome: Stiris restored site performance, allowing recruitment to restart and exceeding targets by more than double, a month ahead of schedule.
Challenge
A biotechnology company hired Stiris to rescue a Phase II/III multiple sclerosis clinical trial in North America after a series of systemic failures.
Poor monitoring, lack of responsiveness, ineffective project management, and inadequate oversight had deteriorated relationships with the sites to the point that they flatly refused access to the CRO. Visits and communication ceased, and patient recruitment stopped completely.
Several sites were completely disengaged, even from the sponsor, creating serious risks to Good Clinical Practice (GCP) compliance, patient safety, and data integrity.
In response, a European expansion was initiated to compensate for the delays, but recovery in North America was critical to meet timelines, without further burdening the already overburdened sites.
Solution
Stiris implemented a clinical trial rescue strategy focused on rebuilding trust before restoring operations.
- Listening-first site engagement: Initial on-site visits had a single agenda in understanding site concerns. No monitoring, no file review. Sites were heard before any corrective action was taken.
- Targeted recovery plans: Each visit produced actions aligned to real capacity and constraints, a tailored action plan, and defined follow-up timelines based on each site’s current capacity.
- Hands-on execution: Stiris worked directly with site staff to clear data query backlogs, some exceeding 500 open queries per site, and address regulatory gaps.
- Sponsor-CRO alignment: Stiris and the sponsor’s Clinical Operations Director maintained continuous, transparent communication, presenting a unified voice to sites throughout the rescue.
Results
- Recruitment restarted across all North American sites and exceeded targets by more than 2x.
- Enrollment milestones were achieved one month ahead of schedule.
- Full re-engagement across all North American sites.
- A key opinion leader (KOL) who had previously refused participation rejoined the study and proactively began identifying patients ahead of site initiation.
- Data integrity and regulatory documentation restored to GCP standards at all sites.
- Site relationships strengthened sufficiently for sites to consider future studies with the sponsor.
Impact
The sponsor secured trial continuity, restored GCP-compliant oversight, protected data integrity, and strengthened site relationships, enabling progression to the next phase of development on an accelerated timeline.
Key Takeaway
When failures damage site relationships, a high-engagement, site-first approach can restore trust and accelerate trial recovery faster than traditional CRO models. Stiris demonstrated that rebuilding human relationships is the critical path in clinical trial rescue.
Is Your Trial at Risk?
Site disengagement, recruitment delays, and CRO performance failures can put your trial’s data integrity, timelines, and investment at serious risk. Stiris Research specializes in clinical trial rescue, rebuilding site relationships, restoring GCP-compliant operations, and recovering recruitment when it matters most.
Partner with Stiris Research to re-engage your sites, resolve data backlogs, and get your trial back on track, before the damage becomes irreversible.