eSource vs EHR/EMR: Why Sites Prefer eSource for Clinical Trials 

The integration of technology in clinical trials increases accuracy, efficiency, and regulatory compliance. While both Electronic Health Records (EHRs) and electronic Source Data (eSource) systems are key components in this shift, they serve fundamentally different functions within the clinical trial process. EHRs primarily focus on patient care and are intended for clinical workflows, whereas eSource … Read more

Reduce Timelines in Clinical Trials – How to Standardize Study Start-Up and Capture Timing Metrics

An analysis published in the National Library of Science identified that key drivers for start-up delays in clinical trials include categories such as inefficient processes/pitfalls as well as contracts and budgets. Academic Medical Centers (AMCs) and health networks conducting clinical trials are constantly striving to streamline trial workflows, reduce cycle times, and deliver faster, more … Read more

What is eRegulatory in Clinical Trials?  

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, ensuring they are stored, tracked, and accessed securely. Today, eRegulatory solutions play a … Read more

Improve Your Study Pipeline: Essential Performance Metrics for Clinical Research Sites

A clinical research site’s study pipeline is tied to its overall performance, with CROs and sponsors rewarding sites that demonstrate efficiency, reliability, experience, and strong patient recruitment capabilities with more trial opportunities. Maintaining a strong and efficient study pipeline is critical for the success of any site. Having a well-managed pipeline ensures a steady flow … Read more

eSource vs. Traditional Paper-Based Methods in Clinical Trials 

The evolution of data collection and management in clinical trials has seen a significant shift from traditional paper-based methods to electronic source (eSource). This transition has brought about profound changes in how clinical trials are conducted, driving increased data precision and staff efficiency, and the overall management of clinical trial data. Here, we dissect the … Read more

Standardizing Pipeline Management and Study Start-up in Clinical Trials 

As clinical research organizations grow, many tasks can become siloed and the overall lack of transparency can lead to inefficiencies, delays, and increased costs. Standardizing study start-up and pipeline management is crucial for improving trial efficiency, ensuring regulatory compliance, and enhancing data quality. By implementing a centralized platform and establishing standardized operations across all site … Read more

Top 5 Challenges in Clinical Trial Study Start-up and Pipeline Management 

Top 5 Challenges in Clinical Trial Study Start-Up and Pipeline Management

Study start-up and pipeline management are fraught with challenges that can hinder progress and efficiency. These complex processes involve meticulous planning, coordination, and execution from all parts of a research site organization, leaving ample opportunity for delays. Despite advances in technology and methodologies, research teams continue to face significant challenges that can extend timelines and … Read more

Improving Clinical Trial Compliance: Top 5 eRegulatory Features for Academic Medical Centers  

RealTime eClinical Solutions - Improving Clinical Trial Compliance: Top 5 eRegulatory Features for Academic Medical Centers

At the center of every clinical trial lies a maze of regulatory requirements, from FDA regulations to institutional review board (IRB) approvals, and improving compliance in clinical trials remains an imperative. For academic medical centers (AMCs), ensuring compliance with these regulations can be an overwhelming task, often requiring extensive paperwork, meticulous documentation, and stringent adherence … Read more

Understanding the Current Site Sector Consolidation Trend

RealTime eClinical Solutions - Understanding the Current Site Sector Consolidation Trend

The clinical research industry is undergoing a profound transformation, driven by market consolidation and technological innovation. To adapt, clinical research sites are embracing innovation, increased collaboration, and strategic positioning to thrive. The site consolidation trend shows no sign of abating. In this blog post, we caught up with Barry Lake, co-founder of Devana Solutions, a … Read more

Negotiating Sponsor Reimbursement for Site-based Technology​ – A Complete Guide for Clinical Research Sites

Negotiating Sponsor Reimbursement for site-base technology: A complete guide for clinical research sites

Clinical research is undergoing a significant transformation, driven by the adoption of site-based electronic systems. As the industry shifts towards these advanced digital platforms, including virtual visits, telemedicine, and sophisticated data management systems, their value becomes increasingly evident. eClinical technologies are improving the efficiency of clinical trials and becoming integral to their success. Consequently, a growing … Read more