The eSource Initiative will support TransCelerate Member Companies in accelerating the uptake of eSource for clinical trials. Although regulators have urged increased use of eSource for several years, application of the use of electronic sources of data for clinical trials has been slow to be adopted across the industry, particularly for registration trials, due in part to difficulties in operationalization. Research indicates there are numerous obstacles and challenges behind this delay; some real and some perceived. The eSource initiative seeks to assist member companies, and ultimately other trial sponsors in overcoming these real and perceived challenges to influence more efficient data gathering practices to benefit patients, sites and sponsors.
- Better alignment for all stakeholders
- More informed vendors
- More engaged patients
- Greater efficiency for sites and monitors (potential for full RBM)
- Potential to eliminate duplicate data entry, reduce transcription
- Potential for improved Health Authority review/approval process
- Greater traceability for end to end data flow
The following assets are in development:
- Points of view defining a framework to enable adoption of eSource
- Model playbook for sponsors to facilitate implementation of e-Source
- Collaborative Health Authority engagement plan and materials
- Validation projects to demonstrate success with eSource for clinical trials for registration
The Initiative’s first landscape analysis can be read by clicking to our Initiative Assets page below.
Quality Management System
Through partnerships with Health Authorities and other industry stakeholders, the Quality Management System (QMS) Initiative aims to explore ways to improve quality across the industry.
Risk Based Monitoring
TransCelerate’s Risk Based Monitoring initiative seeks to develop an model approach for risk-based monitoring of clinical trials, with the goal to both enhance patient safety and ensure the quality of clinical data.
Clinical Data Transparency
The Clinical Data Transparency Initiative was formed with a mission of developing a model approach for redacting privacy information found in clinical study reports and a model approach for the anonymization of patient-level data shared with the broader healthcare community.