Clinipace is pleased to announce our next webcast on Wednesday, April 5, 2017 at 11:30 ET titled:
“An Overview in Clinical Data Standardization in Electronic Submissions.”
Regulatory agencies across the globe are increasingly requiring standardized data during the submission process. Regulatory authorities, sponsors and patients benefit from the efficiency gained through standardized data in a submission process.
CDISC provides most of the data standards, like SDTM and ADaM, requested by regulatory authorities — making in-depth knowledge of these standards key for a successful submission. Working with a knowledgeable industry partner to help you understand and stay abreast of evolving requirements is critically important to your success.
Tune in to this no-cost, educational webcast to learn more about:
- Benefits of clinical data standardization
- How international requirements for data standardization differ between regulatory agencies, including the FDA and PMDA
- The goals and background of different CDISC standards, including SDTM and ADaM
Who should listen to this presentation?
Professionals who plan and/or outsource clinical studies and want a general understanding of data standardization — especially those involved in an electronic submission in near future.