Discover Pharma: REDCap Cloud to power AI-driven research

News Provided: September 24th, 2025

REDCap Cloud has launched version REDCap Cloud 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.

platform is designed to meet the intricate data requirements of large-scale research and paves the way for the integration of AI, which is expected to transform research methods and analysis in life sciences.

The company noted that real-world evidence and data, derived from various sources such as patient forms, electronic health records, and wearable devices, are increasingly influential in research.

However, this data often suffers from inconsistencies, quality issues, and comes in various formats.

Research teams are burdened with the task of rectifying errors, filling in missing details, and manually transferring data between different systems.

REDCap Cloud is said to address these issues, providing researchers with an instantaneous view of study performance.

Its automated data quality checks, anomaly identification, and issue triage systems enable the quick production of datasets ready for analysis, complete with auditable data lineage.

REDCap Cloud 2.0 is said to offer universal trial support, which allows the platform’s architecture to handle everything from small single-site pilot trials to complex multi-phase programmes and vast registries. This flexibility is maintained without the need to change tools during the trial.

The platform simplifies the process of implementing protocol amendments, allowing operations to continue without interruption or compliance risks, thereby decreasing the expenses and timeline issues associated with amendments.

With the addition of analytics capabilities built directly into REDCap Cloud, trial teams can now work from a singular, reliable data source. This integration is expected to speed up clinical development and improve collaboration among international research stakeholders.

REDCap Cloud COO Dave Sunderhaft said: “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.

“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.”

Originally published on Discover Pharma, Sept 24th, 2025

About REDCap Cloud (nPhase, Inc.)
REDCap Cloud is an enterprise-grade clinical research data platform that integrates clinical trial and real-world evidence into a unified data layer for clinical decision-making. Purpose-built for life sciences with a foundation in security, compliance and AI-ready infrastructure, researchers can now unlock the full potential of their data.REDCap Cloud is redefining how research data is captured, harmonized, and analyzed across the global healthcare ecosystem.
For more information visit www.redcapcloud.com.