In a significant milestone for clinical research technology, RealTime eClinical Solutions, a renowned leader in this domain, has been selected by one of the top five global Contract Research Organizations (CROs) for its innovative eRegulatory platform. This choice reflects the increasing necessity for efficient regulatory document management across numerous clinical studies worldwide. The latest engagement is set to improve regulatory oversight as this CRO manages hundreds of studies across different investigator sites globally.
As clinical trials expand in scale and complexity, leading CROs are moving away from traditional methods like paper binders and fragmented file systems. Historically, many have relied on outdated eReg tools that struggle to maintain operational transparency or inspection readiness. RealTime's eReg/eISF platform is designed to address these limitations effectively. By establishing a centralized and secure environment, stakeholders—from investigators to monitors—can access the most up-to-date and compliant documentation in real time. This system features automated expiration alerts, built-in version control, and comprehensive audit trails, thereby ensuring that CROs achieve continuous oversight with minimal manual effort.
Stephen Johnson, the CEO of RealTime eClinical Solutions, emphasized the system's design, saying, "Our eRegulatory platform was built to meet the demands of global, multi-site trials where precision, visibility, and compliance are critical." With the recent endorsement from one of the world's largest CROs, the reliability and scalability of RealTime's solutions have been further validated. It joins an impressive roster of clients, including three of the top five CROs and nine of the top ten site networks that currently utilize RealTime's solutions.
RealTime eClinical Solutions is already trusted by over 85,000 studies involving seven million patients around the world. The benefits of adopting their unified platform are impressive: a significant 5-fold increase in inspection readiness is achieved through centralized documentation and automated workflows, while monitoring visit costs can be reduced by up to 75% thanks to remote document access and improved real-time visibility.
Moreover, the platform accelerates study start-up procedures through streamlined delegation and signature workflows, making it a critical asset for an industry that continues to evolve rapidly. Recognition of RealTime's contributions was highlighted recently when they received the 2025 Clinical Trials Excellence Award for Innovation in Digital Platforms, highlighting their role in transforming clinical trial technology.
Johnson further commented on the evolution of the industry, stating, "RealTime's growth reflects a fundamental shift in how the industry approaches technology adoption. The organizations leading the future of clinical research aren't just adopting more tools; they're integrating systems that connect every aspect of the process, which is where RealTime truly excels."
RealTime eClinical Solutions aims to redefine the operational infrastructure of site-based clinical trials through its comprehensive eClinical platform, featuring an integrated Site Operations Management System (SOMS). This system interlinks various components such as CTMS, Devana, eSource, eReg/eISF, participant engagement, payments, and analytics into a cohesive ecosystem, thus enhancing modern clinical trial operations. Its advanced platform, TrialAlign, also extends critical visibility to sponsors and CROs by facilitating site selection, feasibility assessments, and performance analytics.
In conclusion, RealTime eClinical Solutions is not only helping streamline the complexities associated with clinical trials but also setting new standards for efficiency, transparency, and collaborative success in the research landscape. For more information, visit
www.realtime-eclinical.com.