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

Author: Takoda Roland, Director, Clinical Operations

In clinical trials, speed and data quality are essential to success. Delays can postpone access to life-saving treatments, while poor data quality can compromise a study, leading to wasted resources and adverse patient outcomes. Research sites are central to this process, serving as the gateway for patient enrollment and data collection. Identifying and partnering with high-performing sites is vital for ensuring the success of any clinical trial.

Sitero, a site-focused CRO, combined with CRIO, a leading eSource technology provider, found that site performance was enhanced significantly in a pivotal Phase III clinical trial. Over 2.5 years, we analyzed data from 140 research sites across Australia, Canada, and the United States to understand the impact of CRIO’s eSource platform on key performance metrics.

We analyzed the data from this study and compared the performance of sites using CRIO’s eSource against those sites in the same study using traditional methods, focusing on enrollment efficiency and data quality as key performance indicators. What we found highlighted the vital role that eSource technology and site performance play in the overall success of clinical trials.

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

The analysis showed that sites using CRIO’s eSource platform outperformed non-CRIO sites in several key areas:

• 42% Higher Enrollment: CRIO sites enrolled 42% more patients per site.
• Faster Screening and Enrollment: CRIO sites screened patients 31 days faster and enrolled patients 44 days sooner on average.
• Improved Data Quality: CRIO sites experienced 21% fewer major protocol deviations per enrolled patient.
• Higher Patient Retention: CRIO sites achieved a 5% higher patient retention rate.

This case study demonstrates the powerful impact a site-focused CRO can have on enhancing the clinical trial quality by leveraging eSource technology. By partnering with Sitero and CRIO, pharma and biotech companies can boost enrollment rates, accelerate timelines, reduce protocol deviations, and improve patient retention. These improvements streamline the trial process and contribute to more reliable, timely outcomes, ultimately advancing research and delivering innovations to patients more effectively.

Are you ready to experience the transformative power of eSource in your clinical trials? Partner with the Sitero and CRIO experts, to unlock the full potential of this innovative platform and elevate your research to new heights. Contact Sitero today to learn more.