As of March 2024, there are almost 150,000 clinical studies registered in the United States, with Academic Medical Centers (AMCs) overseeing a staggering volume of clinical trials annually across various therapeutic areas. At the forefront of medical innovation, patient care, and medical education, AMCs drive advancements in healthcare while nurturing the next generation of medical professionals.
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
Maintaining patient engagement and minimizing dropout rates in clinical trials is a persistent hurdle, with dropout rates soaring up to 30% in some studies. The National Institutes of Health underscores the importance of building trust, engaging communities, and ensuring clear and culturally sensitive communication at every stage, from pre-recruitment planning to post-study dissemination of results.
The adoption of digital solutions is becoming commonplace due to the increased efficiencies of electronic solutions in maintaining compliance in clinical trials. In this blog post, we’ll explore the critical components of going digital with electronic delegation of authority, electronic signatures (eSignatures), and audit trails – and how they are safeguarding compliance and patient safety … Read more
Clinical trials play a pivotal role in advancing medical research and bringing new treatments to patients. Traditionally, trials have been conducted using paper-based methods for startup activities and beyond, such as negotiating Confidentiality Disclosure Agreements (CDAs) and managing regulatory processes, but the landscape is rapidly evolving. In recent years, there has been a growing momentum … Read more
Clinical trials are fundamental in advancing medical science, offering new treatments and drugs to improve patient care. However, managing these trials is a complex task involving multiple stages and stakeholders. To streamline this process, Clinical Trial Management Systems (CTMS) have become essential for clinical research sites to organize efficient site management.
Technological advancements and adoption in clinical trials continue to reshape the way data is collected, managed, and analyzed by clinical research sites, sponsors and CROs. Over the last decade, Electronic Source (eSource) has gained prominence for enabling direct data entry by investigators, reducing transcription errors and enhancing data quality. eSource in clinical trials is often … Read more
Clinical trials require precise management across various domains such as patient recruitment, data collection, regulatory compliance, and stakeholder communication. While Clinical Trial Management Systems (CTMS) have been pivotal in organizing and simplifying many of these aspects for clinical research sites, the complexity of modern clinical research often necessitates a broader array of solutions. CTMS platforms … Read more
https://vimeo.com/898629213?share=copy Webinar Date: October 25, 2023 Discover the keys to audit readiness in webinar, “Mastering FDA Audit Preparedness: Streamlining Compliance and Easing Site Burden.” Our panel of experts unpack the potential of eRegulatory solutions in solving common compliance challenges. Check out valuable insights that will help you proactively manage FDA audits and compliance requirements. What … Read more
Do you have the right site technology to start studies faster, reduce FDA audit risk and lower protocol deviations? Increasingly, clinical research is transitioning from paper-based processes to the adoption of electronic workflows. In fact, since the FDA’s 2003 draft guidance on electronic technology in clinical investigations, the industry has witnessed a surge in the … 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.
