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its Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers Draft Guidance, reflecting the agency’s acknowledgement of the advancing use of electronic records, systems and signatures in clinical trials.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
In the ever-evolving field of clinical research, technological advancements continue to revolutionize how we conduct studies and collect data. One such innovation is the Realtime-eDOCS solution, a game-changer for clinical research sites. In this blog post, we will explore the benefits this eRegulatory (eReg) solution brings to these sites and how it can enhance their … Read more
Clinical trials are essential for advancing medical research and bringing new treatments to patients. However, the complexity involved in organizing and managing these trials can often result in delays and inefficiencies. To overcome these challenges and accelerate the clinical trial process, it is crucial to focus on streamlining efficiency and collaboration among the multiple teams … Read more
In the fast-paced world of clinical trials, feasibility surveys have become a crucial step in the process. These surveys help researchers determine the viability of their trials and ensure that all the necessary resources and capabilities are in place. However, it is important to recognize that surveys have the potential to be powerful tools in … 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.
