CASE STUDY: Rescuing Site Relationships
A biotech client contracted Stiris to rescue a Phase II/III Multiple Sclerosis trial that was originally being conducted in North America. The study needed to be expanded to Europe to complete recruitment because their North American sites were refusing to work with the current CRO, and recruitment was at a standstill.
Communication and interactions between their current CRO and the sites had eroded to the point that the sites were refusing to allow the CRO back on site.
Sites were voicing their concern about the quality of monitoring, the unresponsiveness of the CRO, and the lack of oversight the CRO was providing. The situation had escalated to the point where some sites were no longer responding to the biotech company’s reach-outs.
- Repair the site relationships so the Sponsor can get their data.
- Get data monitored and cleaned in a timely manner so we could assure sites that their patients were safe.
- Ensure regulatory documentation was complete and accurate at each site.
- Do all of this without causing undo stress and burden at the sites.
Stiris set additional goals which the Sponsor thought would be unattainable but afforded us the opportunity to try. These goals were:
- Repair the site relationships so the sites would want to continue working with the Sponsor for future studies.
- Repair the site relationships so the sites would resume recruitment in the current study.
- Repair the relationship with the KOL who refused to participate, and have that site actively recruit for the study.
The first thing we did was organize on-site visits where the only item on our agenda was to listen to the site, hear what was going well, what they were worried about, and what we needed to fix. No monitoring of data or review of their regulatory files would take place. We would fly to each site just to talk with them.
- At the end of each visit, the CRA summarized what they heard from the site, made sure everyone all agreed with the takeaways and issues to be addressed, and made a commitment for when we would follow up with the site.
- Straight after each visit, details were shared with the Project Manager (PM)
- A site-specific plan of action and timelines was developed for each site.
- Stiris’ PM reviewed the information across all sites, looking for trends and identifying potential risks.
- Stiris’ PM and the Sponsor’s Clinical Operations Director worked closely together, making sure they were aligned, had up-to-date information, agreed on the plans moving forward and the timelines in which we would resolve items with the sites.
- All parties focused on timely, open, and honest communication.
On the first visit, sites were surprised that we did exactly what we said we’d do – listen, not monitor. This sent clear messages: 1) they matter, 2) we listen, and 3) they can trust what we say. Our transparency, open communication, and collaborative approach resulted in a strong team environment being established with the sites.
- Because we followed up on our promises and commitments in the timelines we agreed, trust was re-established.
- When we worked with the sites to help them manage their workload of addressing outstanding documentation issues and data queries (three sites had over 500 data queries each), they saw our commitment to truly partnering with them.
- Stiris was successful in repairing the site relationships for the Sponsor.
- The North American sites resumed recruitment.
- The KOL who had previously refused to participate, agreed to be part of the study and proactively identified patients so they could start recruiting straight after initiation.
- The North American sites recruited more than double the Sponsor’s target and recruitment a month ahead of schedule.
- The Stiris-Sponsor collaboration and our unified voice was pivotal in helping the sites feel safe working on the trial and agreeing to resume recruitment.
“A huge thank you for all your support and patience. I sincerely appreciate everything you have done. You have gone above and beyond what was expected. No one could have done this better than you did.” ~ Sponsor Clinical Operations Manager.