eRegulatory

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

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

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

Clinical trial inspections, monitoring visits, and audits are all important quality assurance measures that are used to ensure the integrity of clinical trials. However, there are some key differences between these three activities that are important for researchers to understand. By taking some time to learn more about them and how to prepare for them, … Read more