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its Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers Draft Guidance, reflecting the agency’s acknowledgement of the advancing use of electronic records, systems and signatures in clinical trials.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
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
Academic Medical Centers (AMCs), sites, and health networks are constantly striving to streamline processes, reduce timelines, and improve outcomes. Central to achieving these goals is the ability to manage trials effectively, ensuring all key players have the data they need to make informed decisions. If you are looking to view, manage, and optimize site performance from … Read more
Clinical trials play a pivotal role in advancing medical research and bringing new treatments to patients. Traditionally, trials have been conducted using paper-based methods for startup activities and beyond, such as negotiating Confidentiality Disclosure Agreements (CDAs) and managing regulatory processes, but the landscape is rapidly evolving. In recent years, there has been a growing momentum … Read more
Technological advancements and adoption in clinical trials continue to reshape the way data is collected, managed, and analyzed by clinical research sites, sponsors and CROs. Over the last decade, Electronic Source (eSource) has gained prominence for enabling direct data entry by investigators, reducing transcription errors and enhancing data quality. eSource in clinical trials is often … Read more
Are your clinical trials ready for an audit, inspection and/or site monitoring visit now? If your organization is running clinical trials, you know that being audit ready is essential to meet Good Clinical Practice (GCP) guidelines, avoid trial delays and disruptions and, most importantly, to protect the rights and safety of human subjects. It’s also … Read more
RealTime eClinical Solutions is a leading, enterprise-grade technology provider facilitating global clinical trials with a comprehensive eClinical platform. Purpose-built for clinical research sites, site networks, academic medical centers, sponsors, and CROs, the platform goes beyond traditional CTMS to empower research and business workflows for modern-day clinical trials.
