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Higher Standards: Achieving Cleaner Data, Faster, from Protocol to Submission

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Standards. They aren’t just for submission, or for eCRFs. When you build CDISC and proprietary standards into all your study functions, from vendor transfer specs to dataset creation, you expedite every leg of the journey to insight. Study builds take days, not weeks, which means enrollment starts sooner. Interim analyses start and finish on time. And with SDTM conversion on demand, you speed the time to decision-making and submission.

Join us to explore best practices for harnessing the power of standards, without a heavy lift. You’ll learn how to make their authoring intuitive, their management transparent, and their application to data capture and third-party transfer virtually automatic. You’ll also learn why pre-submission *validation* remains an essential step, along with how to speed the generation of define.xml files and Reviewer’s Guides, so you’re fit to submit in record time.

Who Should Attend:

  • Standards Managers
  • Clinical Data Managers
  • External Data Managers
  • R&D IT

Topics covered:

  • Clinical Metadata Repositories (CMDR)
  • Electronic Data Capture (EDC) and Case Reports Forms (eCRF)
  • Data transfers
  • Communication and issue resolutions
  • Generation and validation of CDISC datasets (STDM, ADaM, SEND)
  • Define.xml and Data Reviewer’s Guides

Speakers:

Gilbert Hunter
Customer Success Manager
Pinnacle 21 by Certara

Erin Erginer
Director of Product
Pinnacle 21 by Certara


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