A practical approach to adopt eSource for Clinical Trials
Collecting data relating to clinical trials is imperative. The FDA wants to see the direct use of eSource — the collection of original data in electronic format through multichannel integration of several electronic sources in a central hub — for clinical research in regulatory submissions.
There are several challenges, including the absence of uniform standards around the data collection process, for the adoption of eSource in trials in the US. However, a large number of clinical trials now are conducted outside the US. Almost 90% of subjects in recent biologics trials were enrolled outside the US. Adoption of eSource in emerging markets and newly industrialized countries ensure that the data can be used effectively.
The HCL eSource solution enables the successful conduct of clinical trials. Download the white paper to know more.