EDC, ePRO, and eConsent in one validated system — purpose-built for psilocybin, MDMA, ibogaine, ketamine, and next-generation neuroplastogen trials. Compliance built-in, not bolted on.
The infrastructure trusted by the sponsors and CROs already racing the novel therapeutics window.
The executive order created a first-mover window. The sponsors with clean, compliant, submission-ready data will close it first. REDCap Cloud is the only unified platform purpose-built for the complexity of novel therapeutics trials — deployable in days, not months.
REDCap Cloud gives novel therapeutics sponsors a single, validated platform to build, collect, and manage trial data — from first-in-human feasibility through Phase 3 pivotal — without the configuration complexity that kills timelines.
Start capturing data in days with REDCap Cloud’s self-service study builder. No IT team, no dedicated validator required. Pre-built endpoint libraries include MADRS, CAPS-5, CSSRS, TLFB, PANSS, and 100+ CNS and psychiatric scales.
Your compound generates data your EDC was never designed to handle — therapy session logs, cardiac safety monitoring, ePRO, controlled substance dispensing records, and wearable device feeds.
REDCap Cloud captures eCRF, ePRO, and real-world data in one system — with bi-directional data flow that eliminates manual transfers, cuts SDV costs, and gives monitors real-time access to clean data from day one.
Everything you need to get your first trial live.
Full compliance. FDA Priority Voucher ready.
New EO-enabled real-world evidence generation.
A unified system spanning data management, real-time insights, patient engagement, and the largest interoperability ecosystem in clinical research.
Validated to the standards FDA reviewers, VA partners, and federal funders expect — from day one.
Start your journey with REDCap Cloud today — purpose-built for the novel therapeutics era.