Electronic data capture software has created buzz within the clinical research industry. Pharmaceutical companies, medical devices manufacturers, and others involved in clinical research are increasingly using a Validated Clinical EDC System for clinical trials as it helps them automate processes, streamline operations, and eliminate human errors. Automated data collection, randomization, and analysis have made the…
Clinical trials are costly, and researchers involved in the process strive to achieve success. Measuring performance can be tricky. You need to use the right metrics to gauge the efficacy and performance of clinical trials. Clinical trial data management solutions have certainly made measuring and using metrics easier for organizations. Clinical trial sites need to…
Over the years, the size and complexity of conducting clinical trials have grown tremendously. The recent pandemic has only increased the need for robust, efficient, and quick trials that aid therapeutic and treatment development. However, the cost of conducting such trials can’t be ignored. The estimated cost of bringing a viable drug to the market…
FDA inspections at clinical trial sites can cause concern if you’re ill-equipped and not prepared. Various reasons may lead to an FDA inspection. However, it’s essential to understand the reasons and adopt a preventative approach to ensure that your site is safe and secure. One thing you could do is to adopt modern means of…
Billing compliance is an important factor when conducting clinical trials. Researchers and others involved in the process often struggle to achieve accuracy and clarity in billing. Even though the adoption of clinical trial management software has eased the overall process of conducting a clinical trial, it is important to understand the regulations and policies surrounding…
Looking to optimize your organization’s DCTs to improve research access for underrepresented communities? Here’s what our clinical electronic data capture software expert wants you to do: Addressing challenges and assumptions in deploying DCT strategies By paying attention to participant feedback, research teams can continue to adapt to and learn decentralized modalities as required to accommodate…
A clinical trial can only be as strong as the population it’s actively serving and reaching. In addition, the participant population must match the population of those who require treatment. However, a lot of research teams still struggle to retain participants and improve access in clinical trials. While there may be a lot of factors…
While transitioning source documents from paper to eSource, implementing standard templates across the organization for everyone to realize can be helpful, especially when using an intelligent electronic data capture system. When searching for inconsistencies across studies, using two buckets is recommended: therapeutic lines and research categories. Research categories consist of components like ICFs (informed consent…
From an all-inclusive, exhaustive report to a high-level, executive summary with in-depth observations, the amount of detail required in an audit may vary. While a report may only include a range of observations, it may also provide a list of every document reviewed, describing every process reviewed in detail, as well as any audit observations.…
If you have been invited to enroll in a clinical trial, there are many questions that may come to your mind. As you may know, clinical trials are a great way to explore the efficacy of new medical procedures, pharmaceuticals, and devices. They help improve healthcare, which is ultimately beneficial to the patient population. In…