REDCap Cloud unveils new platform to streamline trial data, harmonize RWE, and enable AI-ready studies

REDCap Cloud has announced the launch of REDCap Cloud 2.0, a platform that unifies real-world evidence (RWE) and clinical trial data in a single system. Designed for large-scale research, the platform supports complex data integration and prepares studies for future use of AI in design, conduct, and analysis. 

The launch comes at a time when the volume of clinical trial data is growing rapidly. Research from the Tufts Center for the Study of Drug Development shows that Phase 3 trials now generate an average of 3.6 million data points – triple the volume recorded a decade ago. At the same time, RWE from patient forms, wearable devices, and electronic health records (EHRs) is becoming increasingly important for regulatory and commercial decision-making. However, this data is often inconsistent or incomplete, requiring study teams to manually reconcile errors, fill in missing details, and transfer data between multiple systems. 

REDCap Cloud 2.0 is intended to address these issues by consolidating data from multiple sources into a single interoperable system. This approach allows research teams to access a consistent, near real-time view of trial performance, supporting data monitoring, error resolution, and protocol updates.  

The platform includes standards-based data harmonization, security features, and open architecture to enable interoperability with external systems and third-party tools. Key functions include automated data quality checks, anomaly detection, and issue triage, which together create analysis-ready datasets with full audit trails. The platform also supports a wide range of study types, from small, single-site pilots to complex multi-phase programs and large registries, without requiring tools to be replaced during the course of a trial. 

The system is also designed to streamline protocol amendments, allowing changes to be implemented with minimal disruption and lower compliance risk. These features aim to reduce the time and cost typically associated with study modifications and data reconciliation.  

“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,” said Dave Sunderhaft, COO of REDCap Cloud. 

REDCap Cloud 2.0 also embeds analytics directly within the platform, allowing researchers to work from a singular, reliable data source, and collaborate across global teams more effectively. 

Sunderhaft added: 

“REDCap Cloud 2.0 is not just an upgrade, it’s the platform our industry has been waiting for to unify all clinical data on a standards-based foundation, and proving it at enterprise scale.”