Prism Connect extracts clinical trial information directly from a site’s electronic health records (EHR).
By eliminating the need to enter the same data in multiple systems, Prism Connect increases efficiency and saves cost.
The sponsor receives the data faster, leading to accelerated delivery of novel therapies to patients.
The data is cleaner as many of the data points are migrated directly from the source (EHR).
Reduces source data verification
Data migrated from the EHR in a validated solution does not need to be source data verified (the most expensive component of a clinical trial). Dramatically reducing the number of visits and allowing site monitors to focus on study conduct, not just data collection.
Provides 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 the source document-viewing feature called the Archiver. This is considered by the FDA to represent a certified copy of the source document. The Archiver allows the end user to view this copy of the source data remotely while comparing it to the data captured in the EDC system.
Eliminates double data entry
The duplication of data entry is reduced in the EHR and the EDC system. In a survey of investigative sites, coordinators reported that 80% to 100% of the required study data are already recorded in the EHR system. Since the data migration is cleaner, the site coordinator spends less time responding to data queries that result from transcription errors.
Less time spent on training
Site coordinators can perform all necessary functions within the EHR system they use every day. They do not need to learn a new software program.
The decreased workload associated with doing clinical trials will help reverse the trend of investigators dropping out of clinical research due to the burden of doing trials and increase site satisfaction.
Duke University pilot findings:
A landmark demonstration used the same technology and same standards as Prism Connect and was published in a peer reviewed journal*. The study compared Connect and traditional workflows used for clinical trials. The results were very positive with several key findings:
37%reduction in time needed to enter data
9% to 0%error rate was reduced for auto-populated data
Databenefits were seen with auto-populated and non-auto populated data
*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.