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…
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…
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…
You may acquire and store data digitally using the effective data-collecting technique known as Electronic Data Capture (EDC). Data may be gathered from various sources, including paper forms, digital forms, and mobile devices, with the help of EDC, which is simple to use. To enter data, organize a database, and conduct analysis for clinical trials, clinical…
The research industry is changing rapidly and embracing patient-centric practices. When COVID-19 restrictions came into effect, a large part of the industry moved to remote modalities for the sake of research continuity. With these remote practices, researchers became more conscious of the participant experience and prioritized the participants’ comfort. That said, simply moving to remote research…
Clinical trial training is essential to explain the specifics of a complex research protocol. To that end, the training programs are designed while keeping in mind good clinical practices (GCP), International Conference on Harmonization (ICH), and other regulatory matters. But how can you make your clinical trial training more effective and streamlined? Here are some tips…