Accelerating Rare Disease Trials with Reusable EDC Libraries and Seamless Integrations

Background & Challenge

Since 2010, a leading biopharmaceutical company specializing in rare diseases has partnered with Sitero to support its rapidly expanding clinical trial portfolio. With many new studies launching annually—and frequent transitions from Phase 2 to Phase 3—the sponsor needed a faster, more scalable approach to building and deploying Electronic Data Capture (EDC) environments, while ensuring accuracy, compliance, and consistency across trials.

Rare disease trials are uniquely challenging: small patient populations, protocol variability, and tight timelines make operational efficiency critical. To meet this demand, the sponsor turned to Sitero for a tailored, high-impact solution.

Sitero’s Solution

Sitero created and now maintains a dedicated EDC form library for the sponsor. This curated library allows teams to reuse standardized forms across studies—leading to:

  • 30–40% form reuse, significantly reducing build timelines
  • Faster startup across complex and variable rare disease protocols
  • High-quality, consistent implementation aligned with regulatory standards

In parallel, Sitero collaborated with the sponsor to design a custom EDC-to-EDC integration framework, enabling seamless data transfer between trials. This capability is rarely offered by other providers and is particularly valuable for extension studies and Phase 2 to Phase 3 transitions, reducing manual effort and preventing data migration bottlenecks.

This efficiency is made possible through a high-trust partnership. The sponsor provides detailed source documents—such as data definition files (DDFs) and edit check specifications—rather than just study protocols. This approach delivers several key benefits such as, reduced ambiguity in requirements, less re-work, fewer revisions, and shorter UAT cycles due to clear, shared expectations.

Outcome

Building on this foundation, Sitero and the sponsor continue to expand the form library and explore further efficiencies to support the next generation of rare disease trials.

Key results include:

  • Up to 40% faster study builds with form library reuse
  • Up to 30% time saved during study transitions through EDC-to-EDC integration
  • Fewer UAT cycles driven by precise documentation and close collaboration
  • 15+ year partnership built on trust, efficiency, and innovation

Customer Feedback

“Highly recommend to anyone working at sites that have ever wished a clinical trial system would work better or differently! The Sitero team is incredibly receptive and have made great updates based on feedback in the past, and your feedback would be impactful! I’ve had great experience with the Bioclinica turned Clario turned Sitero EDC system for many years in large part because it is easy for sites, intuitive, and low impact. Making things easy and intuitive for sites is an incredibly critical step for ensuring data quality and accuracy that is often overlooked.”

– Associate Director, Clinical Data Management