Events and Networking

Expand Your Network at One of Biocom’s 150+ Annual Events

How to Develop a Clear and Compliant Clinical Data Submission Strategy

When:

Wed Feb 14 16:00:00 GMT 2018 - Wed Feb 14 18:00:00 GMT 2018

Where:

Biocom - McGraw Conference Room
10996 Torreyana Road Suite 200
San Diego, California 92121

Register

Accenture’s Clinical Data Operations Director, Brian Hermann will host a seminar focusing on how to plan and prepare your clinical data for submission readiness within Module 5. The seminar discusses up-to-date information that will better prepare your company for the rigors of preparing your clinical data packages in accordance with current guidance. Learn how to develop a clear and compliant clinical data submission strategy based on studies showing where many companies struggle during the submission process.
 
Both early-stage companies who are new to the clinical data submission guidance’s, and portfolio builders who want to enhance their current clinical data submission knowledge, will benefit from attending the seminar.
 
We plan to cover the following topics:

  • CDISC
  • Recent binding guidance from FDA (effective Dec 2016)
    • Waivers
    • Exemptions
    • Timelines
  • Study Data Technical Conformance Guide
  • Study Data Standardization Plan
  • Data Traceability and the FDA
  • Define files
  • Reviewers guides
  • Annotated CRFs
  • Pinnacle21 Data Validation
  • Coding
  • Pooling
  • Submission Timelines

Price of Admission

Bioocm Member

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Biocom Non-Member

Today's Price: 20.0

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20.0

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