EDC for decentralized clinical trials: consent, data capture, and patient touchpoints in one platform with 21 CFR Part 11–aligned controls.
21 CFR Part 11 aligned · HIPAA-aligned security · No credit card required
A decentralized clinical trial is not just a traditional study with fewer site visits. The participant journey may include remote screening, electronic consent, home-based assessments, ePRO diaries, telemedicine follow-up, safety reporting, and periodic site interaction. If each touchpoint is managed in a different tool, the team can lose the simple question that matters most: what happened to this participant, when, and under which consent and protocol version? Capture supports a more coherent DCT workflow by keeping eConsent, EDC, ePRO, safety forms, queries, and exports in one platform. Remote consent records can be tied to participant enrollment. Patient-reported data can be scheduled around the protocol. Site-entered CRFs can document remote visits, follow-up calls, eligibility review, safety checks, and protocol deviations. The study team can then review a participant record without stitching together separate vendor exports. This traceability is especially important for decentralized trials because data is collected outside the traditional site environment. A unified record helps sponsors, monitors, and investigators understand whether assessments were completed on time, whether participant-reported data aligns with visit data, and whether safety follow-up was documented appropriately.
Many decentralized trials begin with a stack of separate tools: one for eConsent, another for EDC, another for ePRO, another for reminders or patient touchpoints, and spreadsheets to connect what the tools do not share. That approach can work, but it creates operational drag. Sites need to learn multiple systems, participants receive fragmented instructions, and data teams spend time reconciling files instead of reviewing study quality. Capture reduces that burden by combining the core data capture workflows in one system. The same platform can support electronic consent, site-entered forms, patient-reported outcomes, safety documentation, role-based review, and analysis exports. This does not mean every DCT service has to live inside Capture; telemedicine, labs, devices, and logistics vendors may still be part of the study. The key is that the clinical dataset stays governed in one place. For lean sponsors and CRO-independent teams, that simpler architecture can shorten setup and reduce the coordination work around amendments, user access, training, and data review. The team has fewer interfaces to reconcile and a clearer operating model for sites and participants.
Monitoring a DCT requires more than checking whether forms are complete. The reviewer needs context: when the participant consented, which assessments were scheduled, which were completed remotely, whether ePRO entries were missed, whether safety follow-up occurred, and whether any protocol deviations affected the endpoint. When remote data is fragmented, monitors can spend too much time reconstructing timelines. Capture gives monitors and sponsor reviewers a structured view of remote study activity. Query workflows can be used to resolve missing or inconsistent records. Audit trails show changes to participant data. Role-based access lets monitors review data without giving them unnecessary edit permissions. Exports preserve the structure needed for analysis and reporting after the remote workflow is complete. This matters for inspection readiness and internal decision-making. Decentralized studies can be credible and efficient, but only when the data record is easy to follow. By keeping remote consent, CRFs, ePRO, and safety review under one audit model, Capture helps teams maintain the same discipline expected in site-based trials while supporting a remote participant experience.
Overview
Decentralized clinical trials (DCTs) reduce or eliminate in-person site visits by using remote consent, telemedicine, and patient-reported or home-based data capture. Your EDC must support electronic consent, remote visit and ePRO workflows, and full auditability so the entire patient journey is traceable. Capture provides EDC, eConsent, ePRO, and safety in one platform with 21 CFR Part 11–aligned controls and HIPAA-aligned infrastructure, so DCT teams can run end-to-end remote workflows across consent, data capture, and patient touchpoints without stitching together multiple vendors.
Decentralized trials require consent, CRFs, and ePRO in one flow so patients and sites have a single experience and one audit trail. Legacy setups often combine separate eConsent, EDC, and ePRO tools, complicating remote workflows and monitoring. Capture is built for end-to-end remote workflow: electronic consent, visit-based and ePRO data capture, and patient-facing touchpoints in one platform with 21 CFR Part 11–aligned controls and HIPAA-aligned security.
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