REDCap Cloud has launched version 2.0, a clinical trial data and analytics platform designed to unify real-world evidence and trial data within a single system. The platform aims to address the increasing complexity of global clinical research and provide a foundation for AI-enabled analytics.

As studies grow more complex, clinical teams face unprecedented volumes of data from multiple sources, including case report forms, electronic health records, labs, and wearables. Tufts Center for the Study of Drug Development (CSDD) recently reported that phase 3 trials now generate an average of six million data points, a 6.4-fold increase compared with 2020. Reconciling these diverse streams, often with errors or missing information, can delay analysis and decision-making.

REDCap Cloud 2.0 harmonizes system-generated and external real-world data in near real time, delivering a consistent, standards-based dataset ready for analytics and AI. The platform supports industry standards such as CDISC (SDTM, ADaM) and HL7 FHIR and integrates with over 90 external sources, including EHR systems, labs, imaging, and device data streams. Compliance frameworks include FDA 21 CFR Part 11, EMA, ICH, ISO 27001, SOC 2, HIPAA, and GDPR.

“For the first time, sponsors can see how a study is performing clinically in near real-time, compressing the ‘white space’ between data collection and scientific review and enabling teams to accomplish in days what previously took months,” Dave Sunderhaft, chief operating officer of REDCap Cloud, said. He added: “We didn’t just build REDCap Cloud 2.0 to keep pace with the industry—we built it because the way clinical data is managed today is not designed for our modern world where data comes from many places, in different forms. For years, sponsors and researchers have been trapped by fragmented systems, endless manual reconciliation, and months lost in the ‘white space’ between data capture and scientific review. We knew there had to be a better way.”

The platform offers automated data-quality checks, anomaly detection, and issue triage, reducing timelines and improving dataset reliability. Its flexible architecture scales from single-site pilots to large Phase I–IV studies and registries. REDCap Cloud also supports protocol amendments without halting operations, enabling sponsors to adapt quickly while maintaining compliance.

According to Sunderhaft, REDCap Cloud’s design is already proving effective at enterprise scale. A recent deployment with a top-5 pharmaceutical company reduced data management timelines by approximately 98%, compressing months of work into days. Full details of this deployment will be shared publicly in October following internal and client reviews.