Decentralized Clinical Trials

Decentralized clinical trials shift parts of participation off site through telehealth, home health, wearables, eConsent, and direct-to-patient supply. Viltis helps sponsors and CROs design DCT elements that fit the protocol and still meet GCP expectations for informed consent, source data, investigational product control, and participant safety. Hybrid models are common; we focus on which activities can leave the clinic without weakening data credibility. Every decentralized activity needs an owner, a documented process, and a place in the TMF.

Technology choices matter less than how they connect to the EDC, safety reporting, and monitoring plan. We review vendor qualification, Part 11 or Annex 11 expectations for electronic systems, and training for sites and home-health partners. Privacy, identity verification, and chain of custody for samples or IP shipped to homes are treated as study-critical controls, not secondary IT topics. When a wearable or ePRO device fails to sync, the protocol and data management plan should already say what happens next.

Operationally, we help teams rewrite visit schedules, define remote versus on-site monitoring triggers, and document how protocol deviations will be handled when a home visit fails. Inspection readiness for DCT studies requires a clear story: what was decentralized, who was responsible, and how source was retained. We also help sites understand which tasks remain theirs so decentralization does not become an excuse for unclear accountability.

Participant burden and retention are part of the design review. A hybrid schedule that looks efficient on paper can still fail if home visits, device charging, and clinic procedures stack poorly. We pressure-test those schedules with clinical ops and sites before go-live, then adjust based on early enrollment experience rather than waiting for a mid-study crisis.

Decentralized trial support commonly covers

• Hybrid protocol and visit schedule design review
• eConsent and telehealth process mapping
• Vendor qualification for DCT platforms and home health
• IP and sample chain-of-custody controls
• Remote monitoring and risk signal definitions
• Source data retention and TMF filing for DCT activities
• Site and participant support model design

If you are adding decentralized elements to a study or recovering from a DCT pilot that created more noise than enrollment gain, we help reset the design around GCP-defensible operations.