sIRBs multi-site research Historically, research organizations and sites have relied on the institutional review board (IRB) and its oversight. sIRBs multi-site research is an important characteristic today. These committees are usually locally managed by the research institutions themselves, but in some cases, the organization also chooses independently administered IRBs. Recently, there has been a change…
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…
Electronic Patient-Reported Outcomes, or ePROs, are a type of electronic data-capturing method mainly used in clinical research and the healthcare system. Patient-reported outcomes (PROs) are any aspect of a patient’s health status that is reported by the patient directly, excluding any interpretation done by a professional along with the way. ePROs is the technology that uses…
While there are certain set criteria that exclude patients from participating in clinical trials, and many times researchers themselves have parameters, it’s also important to look at the flip side. For a clinical trial to be truly successful, it needs a comprehensive EDC software program and a concerted effort to carry out inclusive and ethical research. Here are…
Clinical trials are a significant component that improves patient care and advances medical research. Data management in clinical trials provides valuable insight into new interventions and treatments. An increasingly popular aspect of these trials is patient data registries. A patient data registry is a centralized form of database related to patients with a specific disease or…
With time, research organizations are becoming more efficient and patient-centric. The current research methodology embraces technological advancements and explores remote options. The COVID-19 pandemic has been critical in taking the research industry towards a virtual, flexible approach from the traditional brick-and-mortar site. This is where the decentralized clinical trial (DCT) model comes in, and today…