With time, clinical trials are becoming more intricate and convergence of forces—including precise value differentiation, increasing protocol complexity, and more emphasis on patient experience—is accelerating this intricacy. Clinical electronic data capture systems and processes have evolved to include adaptive designs, DCTs (decentralized clinical trials), increased data volume and precision, and an ever-expanding array of data…
Since technological advancements have allowed for more data-driven clinical research, centralized monitoring in clinical trials has become an important approach in off-site and on-site monitoring plans. Here, we discuss the importance of centralized Monitoring in clinical trials for data integrity in clinical trials. 1. Centralized Monitoring in Clinical Trials Effect on Cost Efficiency Clinical process…
Digital innovation is becoming more common in the healthcare industry, and new technologies are opening up new ways to improve clinical trial software. But even though these new technologies are exciting for people in the medical industry, patients and doctors face many challenges when they try to use them. Digital in Clinical Trials offer multiple…
There are several key members of the Clinical Data Management (CDM) team. Among the specialists on the CDM team are people who will check and analyze all of the clinical report form (CRF) data entered into the EDC. One of the main goals is to minimize errors and missing data. In general, clinical data management…
Clinical EDC Data Management solutions (CDM) are an essential part of clinical research. Case Report Form (CRF) design and CRF annotation are two of the many CDM procedures that go through a quality check at equal time intervals during a clinical trial. The CDM database check is also a part of these procedures. Here’s what…
Sponsors and sites struggled with clinical trial diversity way before the Coronavirus pandemic began. Approximately 20% of new drugs have different effects depending on an individual’s race. This makes it important for newer treatments to be tested on a diverse patient population. Yet disabled, elderly, Hispanic, and African American patients are typically underrepresented in clinical…
As medical practitioners and researchers learn about the benefits of electronic data capture systems (EDC), their preference for EDC technologies increases. Most clinical studies now use EDC, but some still stick to paper-based clinical data capture and management – generally in smaller phase I studies. Paper to EDC isn’t just about replacing the EDC system…
EDC systems for clinical trials have been in the market for many years; however, there have been a lot of changes in clinical trials in just a few years. A couple of decades ago, paper-based data was the only way to store essential medical information and clinical research data. Today, electronic data capture (EDC) software,…
Successful clinical trials depend on several factors, including the correct and consistent data collection across all test platforms. It’s essential to make sure that electronic data capture (EDC) in clinical trials can access the right data. Let’s look at what can be done to improve clinical EDC training to ensure clean and accurate data is…
Clinical trials can be a long and exhaustive process, often taking years – and that duration highlights the importance of clinical supply chain management. However, they’re a crucial part of a drug or medical device’s development cycle. That’s because drugs and medical devices cannot become available to the public until the clinical trials produce successful…