Purpose-built for lean clinical research teams; including MedTech, Academic Medical Centers, investigator-initiated research(IIS), non-profits, real-world evidence programs, and early-stage biotech organizations.
REDCap Cloud EDC is a validated, cloud-based Clinical Data Management System (CDMS) built for regulated clinical research. Collect and manage data from labs, sites, patients, and digital health devices, all in a single platform that meets 21 CFR Part 11, HIPAA, ICH E6(R3) GCP, GDPR, and ISO 27001 requirements out of the box.
Streamline study timelines by making design changes to active studies easily without the need for migrations
Easy-to-use clinical reporting powers real-world data science by enabling study teams to extract and analyze data from an individual study and across multiple studies and sites.
Designed for ease and efficiency, REDCap Cloud is an all-in-one data management and collection platform that lets you securely build, collect, manage, and visualize studies in real-time.
Every REDCap Cloud package includes global hosting, validated Build/UAT/Production environments, 21 CFR Part 11 compliant electronic records and signatures, daily data backups, software updates, and full Validation, Certification & SOP documentation — so your team can go live without building a validation infrastructure from scratch.
The complete EDC for lean teams running site-based clinical trials.
EDC Essentials gives you everything required to design, deploy, and manage a regulated study — from CRF design through database lock — without the overhead of modules you don’t need.
Everything in EDC Essentials plus the modules that regulated pharma and biotech trials require.
EDC Plus adds Randomization, Medical Coding, and offline data capture for teams running complex, multi-site, or multinational studies where protocol sophistication demands more than a standard EDC.
Everything in EDC Plus plus the full patient engagement suite for decentralized and hybrid trials.
myREDCap Cloud extends the EDC into the patient’s hands, enabling ePRO, eConsent, and remote data collection that feeds directly back into the central study database — no reconciliation, no data silos
Design and deploy adaptive trials, registries, and everything in between. Integrate hundreds of clinical and RWD sources while leveraging global libraries to ensure consistency across the entire trial life-cycle.
Automate the collection, tracking, and notification of both adverse events and serious adverse events in real-time
Leverage the most advanced purpose-built Statistical Computing Environment(SCE) to perform cross study analytics and ML/AI analysis in real-time.
myREDCap Cloud is a comprehensive solution for hybrid or decentralized clinical trials that simplifies patient enrollment and participation throughout the clinical trial process.
Expedited and accurate coding supported by integrated workflows that enable user or auto populating of preferred medical terms from a range of medical dictionaries
Seamlessly integrate eSource and other 3rd party data sources to reduce Site Burden and improve data management.
Electronic Data Capture (EDC) refers specifically to the digital collection of clinical trial data via validated electronic Case Report Forms (eCRFs). A Clinical Data Management System (CDMS) is a broader platform that encompasses EDC alongside data cleaning, query management, medical coding, audit trails, and database lock — the full lifecycle of clinical data from first entry to regulatory submission. REDCap Cloud delivers both in a single unified platform: EDC for data capture, CDMS for end-to-end data management, without the cost or complexity of legacy enterprise systems.
21 CFR Part 11 is the FDA regulation governing electronic records and electronic signatures in clinical trials. For an EDC system to be 21 CFR Part 11 compliant, it must provide a complete and unalterable audit trail of all data entries and changes, enforce controlled access via unique user credentials, support electronic signatures that are legally equivalent to handwritten signatures, and ensure data integrity throughout the study lifecycle. REDCap Cloud is fully validated to 21 CFR Part 11 requirements — these controls are built into the platform, not bolted on as a configuration task.
To learn more about REDCap Cloud’s security and compliance policies, visit our Trust Center here.
Study deployment time on REDCap Cloud depends on protocol complexity, but the platform is built specifically to reduce build timelines for lean clinical research teams. Low-to-moderate complexity studies — including standard Phase II trials, registries, and investigator-initiated studies — can be configured and deployed without custom programming or a dedicated validation team. Mid-study amendments are applied without database migrations or site downtime, which is critical for adaptive and investigator-initiated designs where protocols evolve. Most studies go live within 3-6 weeks of kickoff.
Yes. REDCap Cloud’s Patient Engagement module (myREDCap Cloud) supports the full spectrum of decentralized and hybrid trial models — including ePRO, eCOA, eConsent, SMS patient notifications, and a patient portal for remote data submission. Data from decentralized sources flows directly into the central EDC environment, eliminating manual reconciliation and maintaining a single audit-ready data record. This makes REDCap Cloud a strong fit for hybrid trials where some visits are site-based and others are remote.
Start your journey with REDCap Cloud today – scale for tomorrows novel therapies.