Sponsors are raising their expectations for clinical research sites to deliver higher levels of efficiency, data integrity, compliance, and patient engagement. With advancements in eClinical technology, increasing regulatory demands, and a growing focus on diversity and hybrid trials, the bar for site performance has never been higher. Several key trends are shaping these expectations. From … Read more
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
eRegulatory, often abbreviated as eReg or eReg/eISF (electronic investigator site file), refers to the use of electronic systems to manage regulatory documentation and compliance processes in clinical trials. eReg is an eClinical solution that streamlines the management of critical clinical trial documents. This safeguards that these important documents are securely stored, tracked, and accessed. Today, … 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
Clinical trials operate under a strict framework of regulations and compliance standards, reinforcing the importance of meticulous record-keeping. Well-documented cases such as Vioxx serve as reminders for clinical research sites and academic medical centers conducting clinical trials, highlighting the critical nature of maintaining impeccable organization and regulatory adherence. As the volume of data and documents … Read more
As of March 2024, there are almost 150,000 clinical studies registered in the United States, with Academic Medical Centers (AMCs) overseeing a staggering volume of clinical trials annually across various therapeutic areas. At the forefront of medical innovation, patient care, and medical education, AMCs drive advancements in healthcare while nurturing the next generation of medical professionals.
The adoption of digital solutions is becoming commonplace due to the increased efficiencies of electronic solutions in maintaining compliance in clinical trials. In this blog post, we’ll explore the critical components of going digital with electronic delegation of authority, electronic signatures (eSignatures), and audit trails – and how they are safeguarding compliance and patient safety … Read more
https://vimeo.com/898629213?share=copy Webinar Date: October 25, 2023 Discover the keys to audit readiness in webinar, “Mastering FDA Audit Preparedness: Streamlining Compliance and Easing Site Burden.” Our panel of experts unpack the potential of eRegulatory solutions in solving common compliance challenges. Check out valuable insights that will help you proactively manage FDA audits and compliance requirements. What … Read more
In Mastering FDA Audit Preparedness: Streaming Compliance and Easing Site Burden, a webinar hosted by Complion, an audience poll revealed that 48% of attendees spend anywhere between 6-10 hours, on average, preparing for an audit. We have a solution for that. We caught up with clinical trial experts Amanda Lesinski, Assistant Director of Regulatory Affairs … 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.
