With real-time screening insights, a sponsor shaved 10 months off enrollment — while making life easier for site coordinators.
Being a rare disease study, they recognized that maintaining a direct communication line with the sites enrolling patients would be critical to optimizing enrollment. TruTechnologies, positioned at the forefront of site operations and trusted by clinical research coordinators, was seen as the ideal solution to bridge this gap.
Already leveraging TruTechnologies’ sample tracking platform, TruLab, to ensure protocol adherence and sample integrity, the sponsor requested a configuration that would enable both source data capture at the point of sample collection and the logging of screening activities from the outset. This request became the catalyst for the development of TruScreen, TruTechnologies’ innovative screening oversight solution.
Through a combination of strategic actions, including close collaboration with sites and timely visibility into recruitment activities via TruScreen, the sponsor recognized a 10-month improvement in timeline projections compared to prior studies.
Having worked with TruTechnologies in prior studies, the sponsor’s head of clinical pharmacology valued its proven expertise in sample tracking and protocol oversight — especially in studies where biomarker integrity was critical. In this trial, ensuring precise handling of circulating biomarker samples was a key priority, as delays or mishandling could compromise data quality and necessitate redraws.
However, past trials highlighted an even more pressing bottleneck: the screening and enrollment phase at the site level. Even with a CRO’s assistance in coordinating these activities, the sponsor often felt left in the dark, lacking critical information about site progress. This communication gap not only made enrollment forecasting difficult but also limited the sponsor's ability to proactively support sites in this demanding rare disease study. It’s challenging for the sponsor to be on standby for multiple sites around the world without insight into when or where patients are being screened.
By equipping clinical research coordinators worldwide with TruScreen's tools to log screening activities, the sponsor gained timely visibility into critical recruitment metrics. Beyond scheduling updates, TruScreen captured the reasons for screen failures, enabling the sponsor to understand broader trends, such as logistical barriers and competing trials. With enhanced visibility further up the recruitment funnel, the sponsor could make data-driven adjustments that streamlined recruitment while eliminating unnecessary tasks for site coordinators.
Furthermore, TruScreen’s seamless integration into coordinators’ workflows created an efficient, unobtrusive feedback loop that made site participation easy. Coordinators could share updates with minimal effort, enriching the experience for both site staff and the sponsor — a win-win for both stakeholders.
Obtaining timely, actionable insights directly from sites has historically been challenging for sponsors. The intuitive TruScreen platform has proven to be a valuable tool in bridging this gap, providing sponsors with:
• Regular updates on patient screening activities at each site
• Critical insights into the “why” behind screen failures
• A clear understanding of how factors such as inclusion criteria and site location impact enrollment timelines.
This enhanced connectivity between sites and sponsors not only accelerated study timelines by 10 months but also fostered a collaborative sponsor-site relationship. By staying closely connected to sites, the sponsor gained the agility needed to support site operations in real time, adapt to evolving needs, and ensure a more efficient and responsive trial process.