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
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
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
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
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
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
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
According to a review from the National Library of Medicine, clinical trials can fail for many reasons. Among the top five pain points include problems with (i) patient recruitment; (ii) enrollment; (iii) retention; (iv) safety issues; and (v) failing to maintain protocols or FDA guidance. However, from mitigating FDA audit risks to managing patient recruitment and engagement, there is … Read more
As new studies are coming up at your site, there is a lot to think about and prepare for. Getting studies set up in your CTMS for visit and financial tracking is one important process but building great source to drive excellent data collection processes is another major hurdle to being ready to execute. eSOURCE … Read more
RealTime-eSOURCE does the work for you and removes the burden of building source documents. Our system was built and tested by research site professionals, allowing more time to focus on subject recruitment, conducting study visits, and overseeing subject safety. One of the many services that RealTime offers to keep your staff’s focus on what really … 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.
