About Shantell Gomez, eSource Build Specialist: Shantell Gomez is an experienced eSource Build Specialist with a background as a Clinical Research Coordinator in ophthalmology. With deep knowledge of site operations and years of hands-on form building across multiple therapeutic areas, she brings strategic insight, precision, and a user-first mindset to every project. Shantell also leads … Read more
As eSource (electronic source) adoption in clinical trials increases, organizations looking to make the switch are also evaluating the cost-effectiveness and benefits of eSource over traditional data collection methods. eSource enables clinical trial sites to capture, manage, and store data digitally, streamlining workflows and enhancing data accuracy. In contrast, traditional data collection methods, including paper … Read more
The FDA’s recently released draft guidance, “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products,” provides critical insights into how artificial intelligence (AI) can be integrated into clinical trials. This guidance is central to understanding the role of AI in clinical research. It marks a significant step toward … Read more
In clinical research, electronic source (eSource) systems are transforming how data is collected, managed, and utilized. However, as with any technology used in regulated industries, eSource platforms must comply with stringent regulatory requirements to ensure data integrity, security, and traceability. Two primary regulations governing the use of eSource in clinical trials are FDA 21 CFR … Read more
Sponsors are raising their expectations for clinical research sites to deliver higher levels of efficiency, data integrity, compliance, and patient engagement. With advancements in eClinical technology, increasing regulatory demands, and a growing focus on diversity and hybrid trials, the bar for site performance has never been higher. Several key trends are shaping these expectations. From … Read more
Electronic Source (eSource) presents a compelling case for reducing monitoring costs in clinical trials. By streamlining data collection, improving accuracy, enabling remote monitoring, strengthening compliance, and altogether reducing administrative burdens, eSource solutions provide a powerful tool for clinical research sites, sponsors, and CROs looking to achieve better outcomes. There’s a reason why thousands of sites … 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
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
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