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its Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers Draft Guidance, reflecting the agency’s acknowledgement of the advancing use of electronic records, systems and signatures in clinical trials.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
In a world that has become increasingly focused on the capabilities of artificial intelligence (AI), it’s hard to imagine a future without most industries being impacted. But while an AI for every niche business need may still be in the future, advanced technologies offering increased efficiency, quality, and time and cost savings are already here. … Read more
By design, clinical trials are a long and complicated process involving a seemingly endless number of moving parts. It can be difficult to manage everything effectively, especially with the rise of decentralized study teams and more complex trial designs and protocols. For Academic Medical Centers (AMCs) in particular, project management across the entire clinical trial … Read more
According to the National Library of Medicine, an estimated 80% of trials fail to meet enrollment deadlines resulting in recruitment extensions and even termination of studies. If you are a clinical research site owner, this is most likely not a surprise. What you may not know is that this doesn’t have to be a significant problem. … Read more
In our post-pandemic world, contract research organizations (CROs) face more challenges than ever. With greater competition, market consolidation, and a growing emphasis on site empowerment, the CRO market is in a state of flux. Only those willing to be flexible as they apply learnings from the COVID-19 pandemic and its aftermath are likely to come … 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.
