Clinical data standardization isn’t just a formality. When you integrate robust study data standards for regulatory submissions across the study data lifecycle – from eCRF design upstream to SDTM downstream – you expedite every stage of the journey to insight.
With clinical trial data standardization, study build takes days, not weeks. As a result, studies go live faster, and patient enrollment starts sooner. Interim analyses start and finish on time. And standardization of SDTM mapping specifications reduces time to insights and submission.
Watch and learn as we explore best practices for harnessing the power of clinical data standardization – without the heavy lift. You’ll see how to make clinical data standards:
- Simple to define
- Efficient to manage
- Easy to apply to data capture and third-party data transfers
You’ll also learn why continuous pre-submission validation remains an essential step in data standardization for regulatory submission, and how to speed the generation of define.xml files and Reviewer’s Guides, so that you’re ‘fit to submit’ in less time.
This webinar is a must-watch for:
- Standards Managers
- Clinical Data Managers
- Clinical Study Managers
- Regulatory Affairs
- IT Managers
What you will learn:
- How Clinical Metadata Repositories (CMDRs) support end-to-end study data standards for regulatory submissions
- How EDC systems and eCRFs are aligned with clinical data standards
- Best practices for clinical data standardization, including SDTM, ADaM, and SEND
- How CDISC datasets are generated and validated
- How to manage data transfers and efficiently resolve data communication issues
- How to prepare standardized data packages for regulatory submission, including Define.xml and Data Reviewer’s Guides
- How to efficiently manage vendor data transfers and resolve data communication issues
Submit the form now to watch the clinical trial data standardization webinar at your convenience➡️
