Data Submissions Strategy
Customers have limited experience with the requirements for module 5 of the eCTD submission and need support to ensure they have all the necessary deliverables and those deliverables are usable and compliant. They also struggle to coordinate and answer regulatory requests.
d-Wise can help you define, review, and confirm your data submission deliverables to meet regulatory expectations and provide guidance for your submission plan.
Standards Upversioning and
We'll map your legacy standards or existing CDISC standards to the most current standard while capturing all the metadata needed to automate upstream processes.
- • Reduce the time it takes to convert legacy data to CDISC
- • Receive a set of mapping templates to support your study
team and accelerate time to delivering data
- • Provide full set of metadata needed for regulatory submissions
- • Increase knowledge of CDISC within their organization
Delivery of interactive CDISC workshops (including CDASH, SDTM, and ADaM) which provides the knowledge of the standards, real world examples, and hands on exercises to help your organization see the practical application.