The Transformation of Clinical Trials from Writing on Papyrus to the World of Technology
New requirements must be put in place to ensure data quality and integrity.
When Should the Audit Trail Begin?
A discussion of the regulatory history behind audit trails and its interpretation as it relates to clinical research data originating or residing in EDC or eCOA systems.
Keeping Up with the Regulatory Expectations
The Future of ePRO Platforms
It is tempting to imagine the use of the patient's own mobile computing platform for collection of patient-reported outcomes (PROs).
It is tempting to imagine the use of the patient's own mobile computing platform for collection of patient reported outcomes.