Heather Paden, MS, Head, Clinical Operations, PROMETRIKA, LLC
PROMETRIKA Clinical Operations was recently faced with the challenge of initiating the first clinical trial for a specialized research group at a large, academic, world-renowned, oncology research hospital in the US. The excitement of beginning this phase of product development came with many practical challenges – one of which was how to collate and standardize clinical data collected by many non-integrated electronic health record (EHR) systems.
Until the recent wide-spread adoption of EHR systems, source documentation – all procedures, results and medical assessments recorded for a patient – was provided on paper in physical patient charts. Today, most of this information is recorded directly into databases by healthcare personnel. In response, the biopharmaceutical industry envisions the use of EHRs to improve the efficiency and accuracy of data collection in clinical trials. However, the greatest obstacle to integration of EHRs with the electronic data capture (EDC) systems used in the industry is the lack of standardization among EHR products. Continue reading “FDA Addresses the Challenges of eSource Utilization”