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.
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
How to connect WCG IRB Connexus and WCG Velos eResearch CTMS with your eReg/eISF Are delays in site initiation visits (SIV), first person / first visit (FPFV), and delays in getting studies closed creating unnecessary bottlenecks and frustrations running a clinical research study? Is the lack of visibility and control frustrating your ability to monitor … Read more
Technology is shifting the clinical research industry towards electronic solutions that create efficiency while dramatically reducing costs. RealTime-eDOCS™ is the first eRegulatory solution fully integrated with a robust clinical trial management system (RealTime-CTMS™). It’s now easier than ever for sites to eliminate paper-based regulatory binders while managing regulatory documents from study startup to record archive. … Read more
RealTime Software Solutions, LLC, a leader in cloud-based software solutions for the clinical research industry, is pleased to announce the acquisition of Complion, Inc., a leading electronic regulatory (eReg)/electronic Investigator Site Files (eISF) solution provider for clinical research sites, academic medical centers (AMCs), hospitals, health systems, sponsors and contract research organizations (CROs).
eRegulatory, often abbreviated as eReg or eReg/eISF (electronic investigator site file), refers to the use of electronic systems to manage regulatory documentation and compliance processes in clinical trials. eReg is an eClinical solution that streamlines the management of critical clinical trial documents. This safeguards that these important documents are securely stored, tracked, and accessed. Today, … 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.
