The investigator site file (ISF) plays a critical role in a study’s success. But only if the people in charge of it – clinical trial investigators – keep its contents accurate and up to date. In this post, we provide an overview of all essential documentation in an effective, compliant ISF.
Site selection in clinical trials is stunted, often driven by past relationships and familiarity. In fact, studies show that in any given multi-site trial, about 70% of participating sites were previously used by the sponsor1. While there are advantages to reusing known sites, like faster contracting, established workflows, and existing relationships, past collaboration doesn’t always … Read more
Complete profile published here: RealTime eClinical Solutions is an enterprise-grade technology provider and a Dual Category Award Winner in the 2025 Clinical Trials Arena Excellence Awards San Antonio, TX – September 3, 2025 – RealTime eClinical Solutions announces the launch of TrialAlign, a groundbreaking site selection, feasibility, and performance analytics platform designed to help sponsors … Read more
When the FDA announces an audit of your clinical research site, it can feel daunting. However, with proper preparation, your team can confidently navigate the process and demonstrate compliance with regulatory requirements. We’ll unpack essential strategies and practices to help clinical research sites in preparing for an FDA audit, improving the likelihood of a smooth … Read more
In clinical research, electronic source (eSource) systems are transforming how data is collected, managed, and utilized. However, as with any technology used in regulated industries, eSource platforms must comply with stringent regulatory requirements to ensure data integrity, security, and traceability. Two primary regulations governing the use of eSource in clinical trials are FDA 21 CFR … Read more
An interview with Phillip Stanford, Senior Director, Applications & PMO at EmVenio Research, a PCM Trials Company. Q: Can you tell us more about EmVenio Research’s business model and how it’s expanding research to underrepresented communities? A: EmVenio Research provides a scalable network of clinical trial sites. We are strategically located in clinical trial naïve … Read more
Increasingly, clinical research sites are replacing traditional paper-based processes with Electronic Source (eSource) technology in clinical trials. The shift from paper-based processes to eSource represents a significant step forward in improving efficiency, accuracy, and compliance. As sites prepare to make the transition, whether from paper or an existing vendor, it is essential to understand the … Read more
When selecting clinical research sites for their trials, sponsors look for a blend of capabilities, resources, and a proven track record that promises the best outcomes for their studies. With sponsors seeking top-performing sites that align with their trial objectives, the ability to showcase expertise, efficiency, and reliability is key component of successful to success. … Read more
One common frustration in the initiation phase of clinical trials is the frequent occurrence of delays. In an analysis published by Nature, nearly a quarter of all trials experienced setbacks due to strategic issues, commercial barriers, and operational challenges. The financial repercussions of such setbacks are significant, with drug developers facing potential losses ranging from … Read more
Devana Solutions CEO Barry Lake recently sat down with Brad Hightower of the Note to File Podcast to discuss the current state of the industry and the importance of sites tracking their own metrics using clinical trial software like Devana Solutions. Offering holistic trial analysis and a dynamic site and investigator database, Devana Solution’s enterprise software gives businesses the crucial support … Read more
