Recent FDA communications have made clear that poor-quality SEND data can trigger rejections, information requests, and costly submission delays, making robust verification and traceability essential. Managing SEND conversion in-house places significant burden on research teams and introduces quality risks that can jeopardize timelines and regulatory relationships. As the FDA continues to raise the bar, organizations need a reliable, experienced partner to ensure their datasets are submission-ready.
In this webinar, Instem’s SEND specialists explore the FDA’s evolving quality expectations and the most common data discrepancies, traceability gaps, and validation issues that lead to resubmissions and delays. You will see how outsourcing SEND conversion to experienced specialists reduces burden, improves dataset quality, and supports consistent submission readiness across studies.
The session also provides an overview of Instem’s SEND Advantage™ Services, covering the full scope of support available from initial conversion and verification through to regulatory consultation, and includes a live Q&A with Instem’s SEND experts addressing practical guidance for upcoming submissions.
Complete the form to access this recording and discover how Instem’s SEND Advantage™ Services help your organization reduce submission risk and meet the FDA’s growing expectations for SEND quality:
