Clinical research is highly competitive and regulated. Staying on top of study oversight and management is crucial for research sites aiming to run efficient, compliant, and impactful trials. But with many moving parts – including study start-up, patient recruitment, compliance tracking, and more – managing numerous trials across multiple locations can become overwhelming. Many research … Read more
The adoption of eReg/eISF solutions in clinical trials can significantly improve outcomes across Academic Medical Centers (AMCs) and health networks, where efficient regulatory documentation management is essential. eReg/eISF solutions, electronic platforms specifically designed for regulatory document and process management in clinical trials, streamline the entire workflow, from document creation and secure storage to real-time access … Read more
The shift from traditional paper-based methods to electronic source data (eSource) platforms is reshaping data collection and management in clinical trials. In its Draft Electronic Source Data in Clinical Investigations Guidance Document, the FDA has recognized the growing importance of electronic systems in improving data integrity and compliance in clinical investigations. While there is an … Read more
Why Tracking Performance Metrics Matters Academic Medical Centers (AMCs) and health networks, tasked with managing a diverse portfolio of clinical trials, face significant challenges in maintaining operational efficiency, data integrity, and regulatory compliance. One pivotal strategy to navigate this challenging environment is the effective capture and tracking of key performance metrics (KPIs). These clinical trial … Read more
In our blog, “What is eRegulatory in Clinical Trials,” we explored four key trends fueling the adoption of eReg/eISF across Academic Medical Centers (AMCs), sites, site networks, and sponsors. In this follow-up, we dive deeper, expanding on four additional trends driving eReg/eISF in clinical trials. The transition from paper-based systems or disconnected platforms to integrated … Read more
Academic Medical Centers (AMCs), sites, and health networks are constantly striving to streamline processes, reduce timelines, and improve outcomes. Central to achieving these goals is the ability to manage trials effectively, ensuring all key players have the data they need to make informed decisions. If you are looking to view, manage, and optimize site performance from … Read more
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. What’s the difference? EHRs primarily focus on patient care and are intended for clinical workflows, whereas … Read more
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
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
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
