In 2013, the FDA published a final guidance on ‘‘Electronic Source Data in Clinical Investigations’’ which encourages use of electronic source data in the conduct of clinical trials. According to the FDA, integrating clinical trials data and achieving systems interoperability has the potential to improve the reliability, quality, traceability, and integrity of clinical research activities.
The Adaptive eClinical Bus® provides a cost-effective and seamless integration of EHR/EMR, EDC, CTMS,medical device, and other data that supports the FDA’s guidance and provides all of the benefits cited by the FDA including:
- Eliminating duplication of data by capturing and transmitting electronic source data
- Auto-populating electronic study forms from EHRs
- Reducing transcription errors and improving the quality of data
- Encouraging entering source data at the point of care
- Facilitating remote monitoring of data to reduce the number of onsite visits
- Improving site monitoring to minimize the need for cross-reference data in multiple sources
- Making it easier for investigators to conduct clinical research
- Facilitating the inspection and reconstruction of clinical investigations by FDA
Our 30 minute webinar will show you how easily and effectively the Adaptive eClinical Bus can integrate your clinical trials data and provide you with all of the benefits of a validated, standards-based solution that improves your research.