As clinical trials grow exponentially more complicated, support services from clinical data management system (CDMS) vendors are a huge advantage in driving successful clinical studies – and rescuing complex ones that have gone off track.
Clinical trials may run into difficulties and require a rescue study to realign with the original objectives. By this point, considerable amounts of time, budget, and resources have already gone into a study that is failing to progress.
Incomplete or unreliable data is one of the leading causes of a study faltering, which may be caused by an ineffective or misused clinical data management system.
Salvaging a study is far from straightforward, but it is possible and requires critical aspects such as a flexible CDMS and effective migration of trial data. Equally important are support services from the CDMS vendor.
For Fractyl Health, robust support services from Zelta, its EDC/CDMS vendor – coupled with flexibility and scalability enabled by the platform – proved to be exactly what the team needed to rescue a complex study that was at risk of not delivering.
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Fractyl Health rescues a complex study with precision and partnership
LeRoy Stafford, director of data management at Fractyl Health, found himself assigned to a problematic clinical trial in mid-2024 that required urgent rescue to get the study back on track.
Stafford faced multiple technical and logistical complexities that needed to be carefully managed. Fractyl Health was dealing with a high number of case report forms (CRFs) that needed to be set up quickly, a protocol amendment just days from release, and a new internal team that was still being onboarded to support the study.
The study had changed hands several times in over five years, moving from CRO to in-house to back out again. These variables made it difficult to make sense of the data collected and get the study under control.
The first step was to partner with a vendor whose CDMS provided sufficient flexibility to take a protocol and split it into its own study. Functionality is critical for selecting a CDMS partner. Every sponsor, CRO, and study team operates differently, and a one-size-fits-all solution just doesn’t work in today’s clinical trials. Too often, organizations lean on out-of-box-systems that aren’t built to adapt. But when you’re working on complex, high-stakes trials, you need a partner who can tailor technology needs to meet your specific needs.
This multitude of factors is why Stafford ultimately turned to Zelta.
“What I wanted was simple: a system flexible enough to let me take a complex protocol and split into a clean, manageable study,” added Stafford. “My first choice was Zelta. It’s small enough that we can tailor things in-house ourselves and large enough to give us a robust support system. That kind of flexibility was the key for us to move forward.”
Scalability and flexibility in clinical data management systems
As Stafford and his team faced building a new database, he knew the support available from Zelta would guide his team through the build. Support could also proactively identify and remediate any mistakes along the way, and get the database into production in a timely manner.
Stafford needed the flexibility to build on existing systems and add certain modules where necessary. The intuitive design of the Zelta platform enabled the Fractyl Health team, which had little experience, to add modules, like eCOA, as they needed.
Zelta’s flexibility also allowed Fractyl Health to integrate data from separate sources. For example, because the team’s external lab data was not imported into the new database, they continued working with their original lab vendor. Zelta made it possible to work around the two systems while still being selective with datasets as needed.
“I just wanted everything in one system. That way if we had issues, I could go back to the vendor and resolve those issues,” said Stafford.
Stafford explains there was a need to plan for adaptability, meaning the design of protocols required input from cross-functional team members, including biostats, data management, and safety. In other words, getting the right people involved in the study build and UAT avoids having to redesign major parts of the study midstream. These efforts may seem small, but Stafford describes how these actions can collectively reduce the burden on systems and teams down the line.
“Flexibility isn’t just about what your technology does in a crisis,” added Stafford. “It’s about how you plan and collaborate before the crisis arises.”
Risk-based planning and leveraging CDMS support service to avert future study rescues
After being handed a highly problematic clinical study rife with data management complexities, a combination of Stafford’s initiative and the Zelta support team succeeded in getting the trial back on track and under control.
The collaborative support services available ensured that if there were any issues raised or potential problems identified, the Zelta team was on hand to advise on solutions. This ultimately led to Fractyl Health building a new database that met the exact requirements of the study.
As a result of this collaboration, the go-live for this complex Phase II rescue study was dramatically shortened to just four weeks, and the efficiencies delivered crucial cost savings.
“We got a complicated rescue study up and built in record time,” Stafford said. “We got a database into production at MSU (mid-study update) in record time. My team received a lot of praise from senior management – they couldn’t believe that we did this. If you empower your team to be the best they can be – with support from your vendor or a manager – great things can happen.”
Going forward, Fractyl Health intends to design studies in a way that avoids similar challenges – and the need for future rescues like this one – altogether. That means cross-functional, risk-based planning in the build stage: planning with intention and taking a risk-based approach for scaling up trials and positioning resources to position the trial for success from day one.
The future strategy also means leveraging the support service of a partner like Zelta. Fractyl Health and Zelta’s past collaborations together prove how even the most complex rescue studies can be turned around with the combination of an effective EDC/CDMS and robust support services.
The success story also underscores the importance of considering the support service for any organization making a decision on a CDMS partnership. As clinical trials become more complex, the flexibility available from Zelta’s EDC/CDMS and collaborative support services ensure that even the most problematic rescue studies can be salvaged to deliver successful outcomes.
Download the document below to learn more about the services available from Zelta.
