How a Pilot Program Can Help Answer the Questions of Data Sources and Costs to Compliance

IDMP-WP Cover - 2017-01.pngThe path to IDMP is an interesting study in cross collaboration between industry, health authorities, and standards organizations. After the establishment of ICSRs, other standards began to be developed, like the Study Data Tabulation Model (STDM)2, and the Standard for the Exchange of Non-Clinical Data (SEND)3. Then the International Conference on Harmonisation (ICH) developed the eCTD4, which really moved regulatory reporting and submissions into an electronic format and has been adopted by the ICH regions. To prepare for the coming IDMP requirements, a pilot program using a product sampling will tell you much about how you need to proceed with your full IDMP compliance plan for international requirements.

Download to Learn:

  • How IDMP came to be and why it matters to your business
  • Details into the nuances of setting up a successful pilot program from team members to technology
  • How to get an understanding of your full data universe and where to begin

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