ICON plc

Prism Connect is a clinical data technology developed by ICON plc, a global contract research organisation founded in Dublin, Ireland in 1990. Prism Connect is designed to extract clinical trial information directly from a site's electronic health records (EHR) and transfer that data into an electronic data capture (EDC) system, eliminating the need for manual double data entry across multiple platforms. ICON serves pharmaceutical, biotechnology, medical device, and government and public health organisations, providing consulting, outsourced development, and commercialisation services across all phases of clinical research.

The core function of Prism Connect is to bridge the gap between a clinical site's existing EHR system and the sponsor's clinical database. According to surveys of investigative sites, coordinators report that 80% to 100% of required study data are already recorded in the EHR, making automated migration a practical approach to reducing site burden and improving data quality.

Key Benefits

• Cost savings: By removing the requirement to enter the same data in multiple systems, Prism Connect increases operational efficiency and reduces associated costs.
• Process efficiencies: Sponsors receive data faster, which can accelerate the delivery of novel therapies to patients.
• Cleaner data: Because data points are migrated directly from the source EHR, the resulting data is cleaner and more accurate than manually transcribed data.
• 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.
• Elimination of double data entry: Duplication of data entry is reduced across both the EHR and EDC systems. Because the data migration is cleaner, site coordinators spend less time responding to data queries resulting from transcription errors.
• Reduced training requirements: 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 administrative burden associated with conducting clinical trials may help reverse the trend of investigators withdrawing from clinical research and can increase site satisfaction.

Clinical Evidence — Duke University Pilot Study

• A landmark demonstration using the same technology and standards as Prism Connect was published in a peer-reviewed journal: Nordo, Eisenstein, Hawley, et al., A comparative effectiveness study of Connect used for data capture for a clinical research registry, International Journal of Medical Informatics, 103 (2017) 89–94.
• The study compared the Connect workflow against traditional clinical trial data entry workflows.
• Time needed to enter data was reduced by 37%.
• The error rate for auto-populated data was reduced from 9% to 0%.
• Data quality benefits were observed for both auto-populated and non-auto-populated data.

ICON's Broader Technology and Services Context

• Prism Connect is part of ICON's wider suite of eClinical and technology solutions, which are focused on reducing time to market, reducing cost, and increasing quality in clinical development.
• ICON offers end-to-end digital technologies configured for study optimisation, data integration, and analysis, enabling real-time access to data flows and insights.
• The organisation supports decentralised and hybrid clinical trial models, patient access programmes, and a broad range of clinical and scientific operations including biostatistics, pharmacovigilance, medical writing, interactive response technology, and clinical supplies management.
• ICON serves clients across a wide range of therapeutic areas and operates globally, with particular support offerings tailored to small and mid-sized biotechnology and biopharma companies.

Prism Connect is positioned as a tool to reduce site burden, improve data integrity, and streamline the clinical trial process by leveraging existing EHR infrastructure rather than requiring sites to adopt entirely new systems or workflows.