Visual verification and chain-of-custody for the physical side of DCTs — where IMP, samples, and patients meet the real world
Decentralized and hybrid clinical trials move investigational product, biosamples, and study activities out of the site and into the home. SnapTrak adds a visual layer of real-world evidence and traceability — complementing wearables, ePRO, and biosensor data with photo-based verification that sponsors, CROs, and regulators can audit.
FDA’s Conducting Clinical Trials With Decentralized Elements final guidance (2024), together with the 21st Century Cures Act and the agency’s Real-World Evidence framework, has formalized decentralized and hybrid trial designs. Investigational product can now be shipped direct-to-patient, samples collected at home, and assessments performed remotely — but sponsor responsibility for IMP accountability (21 CFR 312.62), chain-of-custody, and data integrity is unchanged.
Today’s DCT platforms do an excellent job capturing digital signals — eConsent, ePRO, televisits, wearables, biosensors. What they don’t capture is the physical side: the condition of a kit when it arrives at a patient’s home, the seal on a vial, the temperature strip on a cold-chain shipper, the packaged biosample before it leaves for the lab. SnapTrak fills that gap with structured, time-stamped visual evidence.
Patient- or HCP-captured photo confirmation of kit delivery, label, lot, and expiry at the point of receipt.
Temperature indicator and shipper-integrity photos that convert ambient excursion risk into auditable evidence.
Seal, label, and packaging verification at delivery — structured proof rather than free-text attestation.
Evidence objects for self-administration, home-infusion, or HCP-witnessed dosing events paired to the visit record.
Verification of sample labeling, packaging, and return-shipping readiness before pickup from the home.
Photo-documented return of unused IMP and destruction events for 21 CFR 312.62 drug accountability records.
A structured visual record stream ready for CRO monitoring visits and FDA inspection on demand.
Link evidence objects to EDC, IRT/RTSM, eTMF, or direct-to-sponsor systems so visual data is first-class.
Rural and low-connectivity patients capture locally, then sync when a connection is available.
Existing DCT stack
eConsent · ePRO/eCOA · televisits · wearables & biosensors · IRT/RTSM · EDC. Captures digital patient signals and study data.
SnapTrak adds
Structured visual evidence for physical events: IMP, samples, kits, dosing, returns. Real-world data the sensor stack can’t see.
Most DCT platforms focus on digital data collection. SnapTrak is designed to sit alongside them — providing the visual verification and chain-of-custody layer that physical supply chains, sample workflows, and patient-side IMP handling still require.
Time-stamped, structured visual records aligned to sponsor obligations under FDA DCT guidance and 21 CFR 312.62.
Close the gap between depot, courier, patient, and return — with photo evidence at every handoff instead of self-attestation.
Feed structured visual evidence into EDC, eTMF, and RWE data pipelines alongside wearable and ePRO streams.
Talk to us about how SnapTrak can strengthen IMP accountability, sample integrity, and real-world evidence capture in your decentralized studies.
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