Background image for Hero section

RWE-Ready EDC for Sponsors Running Observational, Registry, and Phase IV Studies

Real-World Data (RWD) and Real-World Evidence (RWE) support more robust clinical trials and offer a trusted model as the basis for regulatory decision making.

RWD is data collected from a variety of sources including EHRs, claims databases and wearables. With REDCap Cloud’s Unified Data Science Platform, organizations can unlock the value of RWD and RWE, accelerating medical discoveries and improving health outcomes.

 

Benefits of RWD and RWE in clinical research

  • Enhance the external validity of clinical trials by better capturing real-world patient experiences and outcomes
  • Speed up approvals by contextualizing single-arm trial data that demonstrates outcomes without the study drug
  • Support drug development and post-market surveillance to identify new drug targets, monitor safety and efficacy, and support the development of new therapies
  • Improve patient outcomes to identify gaps in care and develop personalized treatment plans that are tailored to each patient’s unique needs
  • Reduce healthcare costs by increasing clinical research efficiency and generating insights for better decision-making
  • To learn more about Real-world Evidence from regulators see: FDA Real-World Evidence guidance | EMA guidance 

Key Features

The REDCap Cloud Unified Data Science Platform helps sponsors, research sites, and healthcare systems collect, integrate, transform, and analyze RWD and RWE. Key features of the platform include:

Case study workflow icon

eSource data integration enhances clinical insights and speeds up timelines by collecting, integrating, standardizing, and analyzing various sources of electronic health data

Medical computer screen icon

EHR Integration service allows for the seamless setup and exchange of HL7 standards-based data between electronic health records and the REDCap Cloud platform

Mid study changes icon

Reporting & Advanced Analytics enhances clinical data management and accelerates timelines across the healthcare ecosystem through improved visibility and analysis of patient data

Safety gateway icon

Data Security and Compliance provides the highest standards of protection and compliance, giving organizations confidence in the security and integrity of their data

Global security and compliance

Medra Coder Icon badge
FISMA compliance icon badge
FDA 21 CFR Part 11 icon badge
ISO 27001 icon badge
HITRUST icon badge
HIPAA compliance icon badge
ISO 27017 icon badge
ISO 27018 icon badge
Clinical Research digital data wave background image

Book a Demo 

Start your journey with REDCap Cloud today –
scale for tomorrows novel therapies.