When conducting clinical trials, collecting high-quality data is of utmost importance. Not only does the data need to be accurate and complete, but it also needs to be captured efficiently to help keep trials on track. This is where Electronic Data Capture, or EDC, plays such a vital role through its ability to simplify, standardize…
The COVID-19 pandemic left an indelible mark on the clinical trials industry, unveiling disruptions and unexpected benefits. Amidst the challenges, accelerated innovation emerged as a silver lining. Notably, EDC systems, decentralization, point-of-care trials, and virtual technologies gained prominence, revolutionizing trial management practices. As we venture into the future, the landscape continues to evolve, and some…
Source Data Verification (SDV) is a critical process employed by clinical research organizations (CROs) to validate the accuracy and integrity of the data collected during a clinical trial. This meticulous method involves cross-referencing the study’s source data with the final report to identify and rectify any discrepancies or errors before they can adversely impact the…
Clinical trial management systems (CTMS) are software solutions that help manage the operational aspects of clinical trials. They are designed to streamline and automate tasks like patient enrollment, study monitoring, and data management. Here are some ways to get the most out of your clinical trial management system. ● Use Electronic Data Capturing (EDC) An EDC system is software…
Study startup is an overwhelming, time-consuming, and occasionally frustrating component of the entire research process. It is notoriously prone to delays and can derail subsequent research activities. To ensure a seamless, swift, and successful study startup process, all stakeholders must cooperate carefully to get the study up and running. Here is a comprehensive checklist to help…
Did you know that Phase III clinical trials create about 3.6 million data points, which is three times more than it did ten years ago? For decades, the Phase III stage has been carried out in the same manner: It can span many years, involves up to 3,000 individuals, and takes place before the medicine or…
Modern technology in the form of digital tools and clinical trial software has changed the mechanism of intervention delivery in research studies. Ever since the advent of smartphones took place, these digital health tools have exploded in research programs. Complete virtual clinical trials can also occur, eliminating the need for in-person researcher-patient contact entirely. This digital approach…
Efficacy Trials or explanatory trials are an effective way of explaining the outcome of an intervention under ideal circumstances. The efficacy in any clinical trial can be measured by estimating the outcomes rate observed in controlled and experimental groups. Research sites chosen for the efficacy trials play a crucial role in ensuring the success of…
Clinical Trials are research studies on new drugs, surgical procedures, and medical devices. According to the National Institutes of Health (NIH), over 300,000 clinical trials are registered worldwide, with over 40,000 in the United States alone. These trials cover various medical interventions, including drugs, surgical procedures, and medical devices. These trials effectively ensure that any new…
During data collection and data entry in a medical research study, errors can occur. Research coordinators handling the shifting of the data might make a mistake in transforming them from paper-based formats to digitized ones. If these errors are left standing and not identified before analysis, they can distort the outcome of the clinical trial, which will…