White Paper

e-Source Data Management for Clinical Trials - Basic criteria and challenges for complying with e-source data management compliance

Learn about :

  • Why Regulatory Compliance risk is the number ONE rated risk by the global firms across several sectors?
  • How companies that are operating in highly regulated industries, particularly on a global level, face a myriad of challenges in keeping pace with fluid regulatory changes?
  • How a well-planned technology plan that encompasses automation and BPM can help companies stay focused on their core business while managing compliance risk?

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The FDA developed and issued a Guidance for Industry document titled, Electronic Source Data in Clinical Investigations. The guidance addresses five general areas:

  • Source data originators
  • Data element identifiers
  • Capture of source data into the e-CRF
  • Clinical investigator responsibilities for reviewing and retaining electronic data.
  • Use and description of computerized systems in clinical investigations.

An all-in-one clinical trial software solution unified with Research and Development, LIMS, clinical, Manufacturing, and Document Management System