eReg/eISF for Sponsors & CROs eRegulatory Enterprise (formerly Complion) or eISF provides trial sponsors and CROs with innovative solutions for electronic Investigator Site Files (eISF) that centralize and streamline site compliance and inspection-readiness. Request Demo Access self-service monitoring and visibility with effective site collaboration. Remote monitoring, decentralized trials, and remote ISF review as an option … Read more
At the center of every clinical trial lies a maze of regulatory requirements, from FDA regulations to institutional review board (IRB) approvals, and improving compliance in clinical trials remains an imperative. For academic medical centers (AMCs), ensuring compliance with these regulations can be an overwhelming task, often requiring extensive paperwork, meticulous documentation, and stringent adherence … Read more
In March 2023, the FDA issued an update to its Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers Draft Guidance, reflecting the agency’s acknowledgement of the advancing use of electronic records, systems and signatures in clinical trials. Accordingly, clinical research sites face increasing pressure to demonstrate adherence to stringent industry … Read more
Did you catch our webinar hosted by ClinEdge, “e-Regulatory Systems – Connecting Sites and Sponsors in a Whole New Way” from August? If not you can watch the recording here. Nathan Levens answered several great questions during the webinar and received additional questions after the webinar ended. Below are some additional questions addressed after the webinar. … Read more
Traditionally, the clinical research industry has utilized a top-down model when adopting new technology. In this model, sponsors and contract research organizations (CROs) have been seen as the innovators in the industry by adopting new technology and pushing that technology down to research sites for collection of records and data. Instead of surfing the wave of … Read more
San Antonio, TX – November 5, 2025 – RealTime eClinical Solutions, a leader in clinical research software technology, today announced that a top five global Contract Research Organization (CRO) has selected its eRegulatory (eReg/eISF) platform to streamline regulatory document management across hundreds of studies and investigator sites worldwide. The decision marks another major endorsement of … Read more
Academic Medical Centers (AMCs) and health systems often rely on Microsoft SharePoint as a document management solution for clinical trials. With its widespread adoption across institutions and integration with existing IT infrastructures, SharePoint may seem like a practical and cost-effective alternative to a purpose-built electronic regulatory (eReg/eISF) system. However, clinical trials operate under rigorous compliance … Read more
For over 10 years, TrueBlue has been utilizing RealTime’s integrated eClinical solutions to manage and streamline their clinical trial processes. As an organization, TrueBlue has already experienced incredible growth, including an acquisition and rebrand in 2022, and looks forward to continuing the expansion of their research capabilities and facilities.
The adoption of eReg/eISF solutions in clinical trials can significantly improve outcomes across Academic Medical Centers (AMCs) and health networks, where efficient regulatory documentation management is essential. eReg/eISF solutions, electronic platforms specifically designed for regulatory document and process management in clinical trials, streamline the entire workflow, from document creation and secure storage to real-time access … Read more
In our blog, “What is eRegulatory in Clinical Trials,” we explored four key trends fueling the adoption of eReg/eISF across Academic Medical Centers (AMCs), sites, site networks, and sponsors. In this follow-up, we dive deeper, expanding on four additional trends driving eReg/eISF in clinical trials. The transition from paper-based systems or disconnected platforms to integrated … Read more
