A version of this story originally appeared on Pharmaceutical Technology.
The story at a glance
- Fractyl Health had to rescue a complex Phase II trial that had changed hands multiple times and faced a number of difficulties.
- Zelta provided a CDMS solution and 24/7 support service that made it possible to quickly build a new clinical study database, add modules on demand, and do it all in just four weeks.
As clinical trials grow more complex, the ability to rescue a struggling study hinges not just on technology, but on the strength of your CDMS partner’s support services. When timelines are tight and data integrity is at risk, having a clinical data management platform with responsive, expert support can mean the difference between failure and recovery.
That was the case for Fractyl Health in mid-2024, when Director of Data Management LeRoy Stafford was tasked with rescuing a high-stakes Phase II trial that had changed hands multiple times over five years. The study faced mounting challenges: a protocol amendment days from release, a new internal team still onboarding, and a backlog of CRFs requiring urgent setup.
Stafford needed a CDMS that could adapt fast—and a partner that could guide his team through the chaos. Zelta delivered both.
Why Fractyl chose Zelta
Implementing Zelta for their clinical trials allowed Fractyl to:
- Rapidly build a new database with minimal disruption
- Seamlessly integrate external lab data without rework
- Add modules like eCOA on demand, despite limited internal experience
Most importantly, it gave Fractyl access to a 24/7 services team that didn’t just respond – they anticipated. Our team flagged issues early, advised on best practices, and helped Fractyl go live on their study in just four weeks, a timeline that exceeded internal expectations and earned praise from senior leadership.
“I needed a system flexible enough to split a complex protocol into a clean, manageable study. Zelta was my first choice. It’s nimble enough for in-house tailoring, but robust enough to offer real-time support.”
-- LeRoy Stafford, Director of Data Management, Fractyl Health
Support services as a strategic lever
For executives overseeing clinical operations, this case underscores a key insight: support services are not ancillary—they’re strategic. In high-risk, high-complexity environments, the ability to pivot quickly depends on:
- Flexible architecture that adapts to evolving protocols
- Collaborative support that empowers internal teams
- Risk-based planning that prevents future rescues
“Flexibility isn’t just about what your technology does in a crisis. It’s about how you plan and collaborate before the crisis arises.”
-- LeRoy Stafford, Director of Data Management, Fractyl Health
From rescue to resilience
Fractyl’s experience with Zelta has reshaped its approach to study design. Going forward, the team is embedding cross-functional input and risk-based planning from day one, minimizing the need for future rescues.
For pharma leaders, the takeaway is clear: when selecting a CDMS partner, prioritize support services as a core capability. The right partner won’t just provide a platform—they’ll help you deliver, even under pressure.
Are your clinical trials running as efficiently as they could?
Clinical trials face increasing challenges, from rising costs and complex protocols to maintaining site and participant engagement. Don’t let these obstacles slow down your research timelines or impact your business goals.
Our whitepaper, “Confidence in clinical trials amid complexity and change,” dives into our industry’s most pressing challenges and offers actionable solutions for CROs and sponsors like you to streamline your clinical trials and boost ROI.
Your resource for smarter trials is a click away. Read the whitepaper to learn more.
