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Electronic Data Capture with REDCap Cloud

An all-in-one, easy-to-use, 21 CFR Part 11 compliant EDC software solution for clinical trials.
Trusted by 500+ clinical research organizations across 50 therapeutic areas.

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.

500

Active Clients

50

Therapeutic Areas

15,000+

Global Sites
REDCap Cloud EDC

EDC

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.

  • Manage studies of any size, complexity, or therapeutic area within a single, unified platform
  • Deliver cross-functional and cross-study insights with a standards-based approach to data management and analytics
  • Accelerate decision making through direct access to study data and real-time dashboards via our web-based portal or mobile EDC app

Streamline study timelines by making design changes to active studies easily without the need for migrations

Reporting and Analytics

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.

  • Create dashboards summarizing information from views with over 40 different visualization options for presenting data.
  • Empowers users to quickly analyze operational processes across studies and sponsors from several pre-built operational data reports including key milestones, enrollment, site status, CRF performance metrics, and queries.

 

REDCap Cloud Reporting and Analytics solution
REDCap Cloud data management life-cycle

Building your first study in REDCap Cloud EDC

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.

  • Create: Create custom screening tools to capture your desired cohort
  • Automate: Use rules and expressions to trigger automatic CRF delivery
  • Standardize: Use medical coding libraries to ensure use of standardized terminology for clinical data
  • Save & Reuse: Save your study as a global template for future use

Choose the right EDC tier for your study

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.

EDC Essentials

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.

 

EDC Plus

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.

myREDCap Cloud

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

REDCap Cloud Solutions

Study Central

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.

Safety Gateway

Automate the collection, tracking, and notification of both adverse events and serious adverse events in real-time

Reporting and Analytics

Leverage the most advanced purpose-built Statistical Computing Environment(SCE) to perform cross study analytics and ML/AI analysis in real-time.

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Patient Engagement

myREDCap Cloud is a comprehensive solution for hybrid or decentralized clinical trials that simplifies patient enrollment and participation throughout the clinical trial process.

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Medical Coding

Expedited and accurate coding supported by integrated workflows that enable user or auto populating of preferred medical terms from a range of medical dictionaries

Interoperability & RWE

Seamlessly integrate eSource and other 3rd party data sources to reduce Site Burden and improve data management.

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Customer Testimonials

POETIC logo
Developing Innovative Treatments for Pediatric Cancer Patients with REDCap Cloud EDC
Cogstate Logo
Making Digital Cognition Assessments Easily Accessible in Decentralized Clinical Trials
Runx1 Research Program
Enabling Real-Time Insights from Patient-Generated Registry Data
Mercy Ships logo featuring a blue ship with green embellishments and blue Mercy Ships text
Reaching Underserved Communities Through an Innovative Approach to Data Collection and Analysis

Global security and compliance

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FISMA compliance icon badge
FDA 21 CFR Part 11 icon badge
ISO 27001 icon badge
HITRUST icon badge
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Frequently Asked Questions (FAQ)

What is the difference between EDC and CDMS?

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.

What does 21 CFR Part 11 compliance mean for an EDC system?

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.

How long does it take to deploy a study on REDCap Cloud?

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.

Can REDCap Cloud support decentralized and hybrid clinical trials?

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.

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