Although many clinical trial sites wish to use technology, they are concerned about software compliance, particularly regarding 21 CFR Part 11 compliance. Using non-compliant technology can result in audits and tense interactions with the FDA and other regulatory authorities. In order to obtain smoother and quicker approvals from the regulatory authorities, researches need to use […]
Read More →The concept of a “digital clinical trial” means leveraging digital technology to improve patient and sponsor experience in handling clinical trials using digital tools to manage end-to-end clinical trial solutions. Digital clinical trials also improve participant access, engagement, trial-related measurements, and/or interventions, enable concealed randomized intervention allocation and has the potential to transform clinical trials […]
Read More →In recent years, hundreds of clinical trial investigations were performed using stem cell to treat common and life-threatening conditions such as heart disease, Alzheimer’s and diabetes. But till now, the only stem cell-based treatment routinely reviewed and approved by the U.S. FDA is hematopoietic (or blood) stem cell transplantation. The efficacy and safety of stem […]
Read More →The efforts in managing and locating files are becoming tiresome for many clinical research organizations. Electronic Trial Master Files (eTMF) software is becoming necessary for managing clinical trial documentation replacing bulky files. If you are in search of an eTMF, then you need to be aware of many aspects and features you need to look […]
Read More →Virtual clinical trials (VCTs), also known as decentralized clinical trials or remote clinical trials, are conducted remotely by taking advantage of technologies and tools such as telemedicine, electronic consent forms, electronic clinical outcome assessment (eCOA), remote patient monitoring (RPM), apps, wearables, digital biomarker collection, and online engagement platforms. Clinical development in drug development is a […]
Read More →Clinical research is conducted according to an action plan known as a Clinical Trial PROTOCOL. Clinical investigation begins with the development of a clinical protocol and writing a research proposal is one of the most challenging and difficult in clinical trials. What is a protocol? The protocol is a document that describes the action plan […]
Read More →Decentralized clinical trials (DCT)s, also known as “direct-to-participant trials,” “virtual” monitoring, or “remote clinical trials“, differ from conventional research studies. These clinical trials use telemedicine, sensory-based technology, home visits, wearable medical devices, patient-driven virtual health care interfaces, direct drug and material delivery to patients’ homes, neighborhood labs, digital consent data gathering, remote monitoring, and diagnostics […]
Read More →Sponsors, Contract Research Organizations (CROs), and sites have adopted Electronic Data Capture (EDC) systems to carry out both simple and complex clinical trials in all phases of clinical research. Clinical trials are moving toward using EDC software, replacing paper records with electronic records. Traditionally, researchers were to use paper-based forms, which in a few cases, […]
Read More →Sponsors and CROs are preparing to conduct more hybrid clinical trials than traditional site-based trials, marking a turning point for the industry. A poll found that 77 percent of clinical trial executives planned to perform hybrid trials next year, up from 59 percent the year before. Hybrid clinical trial models have their roots in decentralized […]
Read More →Clinical biostatistics play a crucial role in the drug development process right from trial design to protocol development. Biostatistics finds applications in various fields such as epidemiology, clinical trials, population genetics, systems biology, and more. Biostatistics is critical to collect, analyse, present, and interpret data in clinical research. it helps in making decisions regarding the […]
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