CRIO & Sitero Partner to Drive Superior Enrollment, Speed, and Quality in Phase III Trial Using eSource

In the world of clinical trials, speed and quality are paramount. Every day a trial is delayed translates to postponed access to potentially life-saving treatments. Furthermore, compromised data quality can jeopardize the entire study, leading to wasted resources and potentially harmful outcomes for patients. Research sites are at the heart of this process, acting as the primary gateway for patient enrollment and data collection. Identifying and collaborating with high-performing sites is therefore essential for ensuring the success of any clinical trial.

A comprehensive analysis spanning 2.5 years and encompassing 140 research sites across Australia, Canada, and the United States sheds light on how CRIO’s eSource platform significantly impacts these critical factors. This case study delves into the data, comparing CRIO users to non-users across key performance and quality metrics, highlighting the vital role that technology and site performance play in the overall success of clinical trials.

A comprehensive analysis of 140 research sites participating in a pivotal Phase III clinical trial managed by a site-focused, tech-enabled CRO, Sitero, reveals a compelling case for sponsors to use CRIO’s eSource platform. This case study delves into the data, comparing CRIO users to non-users across critical performance and quality metrics.

Methodology:

The study examined 140 sites involved in a Phase III trial, segmented into two distinct groups:

• Group A: 56 sites utilizing CRIO’s eSource platform (with 7 sites not screening any patients)
• Group B: 84 sites not using CRIO (with 21 sites not screening any patients)

Key performance and quality indicators assessed included:

• Enrollment Efficiency: Number of enrolled patients per site, time to first screening, and time to first enrollment
• Data Quality: Number of major protocol deviations and early patient terminations

Results:

The data reveals a significant advantage for sites using CRIO across multiple dimensions:

This real-world case study provides compelling evidence that CRIO’s eSource platform significantly enhances clinical trial performance and quality. The data demonstrates superior enrollment efficiency, faster study timelines, fewer major protocol deviations, and improved patient retention among CRIO users.

Key Takeaways:

• CRIO sites enrolled 42% more patients per site.
• CRIO sites screened patients 31 days faster on average.
• CRIO sites enrolled patients 44 days faster on average.
• CRIO sites had 21% fewer major protocol deviations per enrolled patient.
• CRIO sites achieved a 5% higher patient retention rate.

Conclusion

The data from this comprehensive analysis underscores the profound impact that CRIO’s eSource platform has on enhancing the efficiency and quality of Phase III clinical trials. By leveraging CRIO, pharmaceutical companies can achieve significantly higher enrollment rates, faster screening and enrollment timelines, and improved data accuracy, all of which are critical for accelerating the development and delivery of life-saving treatments. The marked improvements in enrollment efficiency, protocol adherence, and patient retention not only streamline the trial process but also contribute to more reliable and timely outcomes. Embracing CRIO’s technology enables pharmaceutical companies to optimize their clinical trial operations, ultimately advancing their research efforts and delivering innovations to patients more swiftly and effectively. To fully harness these benefits and drive superior trial performance, partnering with CRIO and Sitero presents a strategic opportunity for enhancing clinical research capabilities.

Want to learn more? Contact us or visit Sitero’s website to learn more.