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What You'll Learn:
  1. Benefits of clinical data standardization
  2. How international requirements for data standardization differ between regulatory agencies, including the FDA and PMDA
  3. The goals and background of different CDISC standards, including SDTM and ADaM
  4. Deliverables

Who should listen to this presentation:
Those who plan and/or outsource clinical studies and want a general understanding of data standardization in clinical studies, especially staff that will be involved in a electronic submission in near future.

Presented by:

Nicola Tambascia
Principal Statistical Programmer, Clinipace Worldwide
Nicola started programming SAS in 2010 for Sanofi-Aventis in Frankfurt. After finishing his internship, he joined Clinipace Worldwide as a Statistical Programmer for clinical trials. At Clinipace Worldwide, Nicola has worked with various project teams and served statistical programming needs within all major indications. His daily work includes the hands-on application of CDISC standards for regulatory submission as well as consulting clients regarding the implementation of SDTM, ADaM and define.xml.

Free Webcast:

CDISC: An Overview in Data Standardization for Electronic Submissions

Watch the webcast now