View Webinar Recording: eDataValidator (eDV) for Validating SDTM, ADaM & SEND
Having trouble viewing the video? Please click here
Here is a brief overview of the webinar’s key highlights and takeaways.
In this webinar, we provided a 30-minute walkthrough of eDV, demonstrating how users can effectively validate their SDTM, ADaM or SEND datasets. The webinar demonstrates the essential steps involved in validating your dataset, by selecting the appropriate validation rules for submission to regulatory authorities such as the FDA and PMDA.
Key Takeaways for the Audience:
- Efficient Iterative Dataset Validation: Learn how to efficiently validate multiple iterations of datasets for submission. eDV empowers you to streamline the validation process, saving time and effort.
- Interactive QC Dashboard: Take advantage of eDV’s interactive QC dashboard, which enables you to tag and address issues for corrections, SDRG comments, false positives, and more. This feature enhances the overall data quality.
- Draft SDRG Generation: With eDV, you can generate a draft SDRG (Study Data Reviewer’s Guide) that incorporates the validation outcomes.
- Define.xml Generation: eDV includes a Define.xml generator, enabling you to generate Define.xml based on your study dataset. This feature ensures compliance with industry standards and simplifies the regulatory submission process.
PointCross’ eDataValidator is a standalone tool that addresses the needs of Sponsor clinical operations, biostatisticians, and the biometrics community. Our customers expressed the need for an affordable and user-friendly solution capable of validating multiple datasets against the latest validation rules. They also desired a unified QC Dashboard that provides a comprehensive view of structure and content issues, along with intuitive features for validation and submission-related tasks.
We cordially invite you to try eDataValidator with a no-cost 30-day trial. This trial period allows you to explore the tool’s capabilities firsthand and experience its benefits. We highly value your feedback, as it helps us continually enhance eDV to better serve your validation requirements.