Clinical trials require precise management across various domains such as patient recruitment, data collection, regulatory compliance, and stakeholder communication. While Clinical Trial Management Systems (CTMS) have been pivotal in organizing and simplifying many of these aspects for clinical research sites, the complexity of modern clinical research often necessitates a broader array of solutions. CTMS platforms … 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
Do you have the right site technology to start studies faster, reduce FDA audit risk and lower protocol deviations? Increasingly, clinical research is transitioning from paper-based processes to the adoption of electronic workflows. In fact, since the FDA’s 2003 draft guidance on electronic technology in clinical investigations, the industry has witnessed a surge in the … Read more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
Study startup and site activation are key to the clinical trial process, but often suffer from delays. It can be a time-consuming undertaking and requires multiple teams and moving parts to successfully begin a trial at the best sites for the protocol. In fact, a recent ACRP survey revealed that study startup was ranked among … Read more
Regardless of size and type, clinical research site organizations compete for trial opportunities from CROs and sponsors. There are many factors that can make a site stand out amongst the crowd, but turnaround times for key items may be one of the larger deciding factors. CROs and sponsors want to get trials up and running … Read more
According to a review from the National Library of Medicine, clinical trials can fail for many reasons. Among the top five pain points include problems with (i) patient recruitment; (ii) enrollment; (iii) retention; (iv) safety issues; and (v) failing to maintain protocols or FDA guidance. However, from mitigating FDA audit risks to managing patient recruitment and engagement, there is … 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
