Solving Rare Challenges: Q&A Highlights from Our Latest Webinar
On June 4, DFnet hosted a webinar on Solving Unique Data Management Challenges in Rare Disease Trials, with over 120 clinical research professionals. If you missed the session or want to revisit it, you can [watch the full recording here].
Below, we’ve shared a few of the audience questions and responses from our team, covering everything from mid-study changes to working with limited datasets in rare disease research.
Q: How does DFnet handle offline vs. online syncing of data?
A: Our DFcollect app stores data securely on the device when offline. Once the user reconnects, the system initiates a sync process and checks for any discrepancies between the device and server. If a conflict arises, say, the same record was edited on both ends, the system flags it for review, and the user is guided through a simple resolution step. This ensures data integrity and a complete audit trail while enabling fully decentralized operations.
Q: How do you maintain data integrity when dealing with small sample sizes?
A: In rare disease trials, you can’t afford data gaps or inconsistencies. We apply rigorous edit checks at the point of entry, enable real-time monitoring, and support remote source verification. Our CRF completion guidelines and validation rules are designed to ensure every data point is clean, complete, and fully traceable. With smaller datasets, high-quality data becomes even more essential to support statistical power and regulatory confidence.
Q: Can DFnet support randomization in rare disease trials?
A: Yes, we offer both static and adaptive randomization within the database. Rare disease studies often face low and uneven enrollment across many sites, so we monitor balance in real time and adjust as needed. We assign blinded and unblinded statistician roles to maintain trial integrity while ensuring your randomization plan stays on track.
Q: How is personal data redacted for adjudicators reviewing source documents?
A: DFsources allows for secure, compliant redaction of PHI by site staff and any other information that needs to be blinded, such as the study arm, which can be performed by our team at DFnet. With just a swipe, sensitive details are hidden without risk of exposure. Adjudicators only see what they need for review, preserving blinding and protecting participant privacy.
Q: How quickly can DFnet implement mid-study changes?
A: Our mirrored development environment allows us to build and validate changes without touching the live study database. Once everything is tested and approved, updates are pushed instantly with no downtime and no data loss. This flexibility is critical in rare disease studies, where protocol amendments are common, and time is tight.
Need help applying these insights to your next trial? Let’s talk.
