A Top 10 Sponsor Improves Trial Data Quality Through EDC eSource Solution

Introduction
Despite the documented benefits of electronic source data collection methods (i.e., eSource) such as fewer data entry errors, real-time data visibility and improved data quality, the initial switch from traditional paper-based data collection methods to eSource can appear challenging and therefore not worth the risk.

Situation
A medical device company has a long-standing relationship with Bioclinica (>10 years, 380+ studies total) and wanted to increase their data quality while decreasing the monitoring time required during their clinical trials. The sponsor is currently an avid user of the Bioclinica EDC and CTMS systems as well as Bioclinica Data Management services. However, they wanted to decrease the associated time and errors by directly populating the EDC with their assessment data rather than writing the source data on paper for later transcription into the EDC.

Solution
Bioclinica has a history of collaborating with their customers to develop solutions that meet the specific needs of the customer and protocol. To ensure consistent and complete data entry, the Bioclinica team partnered with the sponsor to approach the study build from a different perspective. The forms in EDC are presented to the clinician at each visit in the order of protocol steps for the visit. The flow and field locations on the form mimic the paper source forms and are designed to reflect how site users think while capturing subject information. For example, data for each eye is captured on the same form with one column for the right eye and another for the left eye. The subject’s patient-reported outcomes (PRO) data is also entered directly into the system via a patient-accessed kiosk portal.