Prism

Prism Connect is an eClinical solution developed by ICON plc that extracts clinical trial information directly from a site's electronic health records (EHR). It is designed for clinical trial sites, sponsors, and site coordinators who need to reduce the administrative burden of data entry and improve the quality and speed of clinical data collection.

By migrating data directly from the EHR into the electronic data capture (EDC) system, Prism Connect reduces duplicate data entry, lowers error rates, and accelerates the delivery of data to sponsors. A Duke University pilot study using the same technology and standards as Prism Connect, published in the International Journal of Medical Informatics (2017), found a 37% reduction in time needed to enter data and a reduction in error rates for auto-populated data from 9% to 0%.

Key Benefits

• Cost savings: Eliminating the need to enter the same data in multiple systems increases efficiency and reduces cost.
• Process efficiencies: Sponsors receive data faster, which can accelerate delivery of novel therapies to patients.
• Cleaner data: Data points migrated directly from the EHR source result in higher data quality.
• Reduced source data verification: Data migrated from the EHR within a validated solution does not require source data verification, which is typically the most expensive component of a clinical trial. This reduces the number of monitoring visits and allows site monitors to focus on study conduct rather than data collection.
• Certified copy source: When data is transmitted from the EHR to the clinical database, a copy of the migrated data included in the patient's Continuity of Care Document (CCD) is stored in a source document-viewing feature called the Archiver. The FDA considers this to represent a certified copy of the source document. The Archiver allows end users to view this copy of the source data remotely while comparing it to data captured in the EDC system.
• Eliminates double data entry: Duplication of data entry is reduced across both the EHR and EDC systems. A survey of investigative sites found that coordinators reported 80% to 100% of required study data are already recorded in the EHR. Cleaner data migration also reduces the time site coordinators spend responding to data queries caused by transcription errors.
• Less time spent on training: Site coordinators can perform all necessary functions within the EHR system they already use daily, without needing to learn a new software program.
• Decreased workload: Reducing the workload associated with conducting clinical trials may help reverse the trend of investigators leaving clinical research due to the burden of trial participation, and can increase site satisfaction.

Duke University Pilot Study Findings

• 37% reduction in time needed to enter data
• Error rate for auto-populated data reduced from 9% to 0%
• Data quality benefits were observed for both auto-populated and non-auto-populated data

Prism Connect is part of ICON's broader suite of eClinical technologies. The Archiver feature supports remote review of certified copy source documents, and the solution operates within a validated environment that meets FDA standards for data migration from EHR systems.