DSG eSource

Why eSource?

For several years, concern has been growing for regulatory agencies to modernize and streamline data collection for clinical trials. The drive to embrace electronic solutions for source data is increasing every day. In 2013, the US FDA issued the first guidance for eSource laying out the critical goals, including:

  • Elimination of duplication of data
  • Reducing transcription errors
  • Encourage entering source data during a subject’s visit
  • Eliminate transcription of source data before entering it in an eCRF
  • Facilitate remote monitoring of data
  • Promote real time access for data review
  • Enhance the collection of accurate and complete data

DSG’s eSource Initiative

DSG was the first eClinical provider to work with a sponsor on two Phase III studies using entirely eSource, direct data collection. Working with Sirion Therapeutics and DSG’s eCaseLink™ EDC eClinical software, electronic source and the use of WIFI internet-enabled tablets gave surgeons and study coordinators the mobility they coveted while completely eliminating paper source documentation. This removed the need for source data verification, and dramatically decreased monitoring time and costs for Sirion.

The results: FDA positive audit and final approval. Read more about eSource success at DSG.

DSG eSource Benefits

  • Better alignment for all stakeholders
  • More informed vendors
  • More engaged patients
  • Greater efficiency for sites and monitors with potential for full Risk-Based Monitoring
  • Potential to eliminate duplicate data entry, reduce transcription
  • Potential for improved regulatory review/approval process
  • Greater traceability of data

We are always excited to see new applications complimenting EDC and direct data collections while dramatically reducing resources required to perform a clinical trial. Eliminating paper data review with eSource and now with risk-based monitoring are resource game changers for our industry.