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 […]
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The barriers between IT industries and the clinical research industry is quickly blurring. Now the software tools are sorting the most difficult management tasks in clinical trials. One such challenging task in clinical trials is patient management and engagement. The patient management software very well manages and executes all patient-related tasks effortlessly. While conducting clinical […]
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Patient-focused drug development is a pragmatic shift in the drug development process incorporating patients’ participation right from the first stage of drug development to the end. Patient-centered drug development now has become the talking point in the clinical research industry. It helps to provide meaningful information from participants to researchers in order to perform research […]
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In clinical studies, Electronic Data Capture (EDC) has become the preferred method to capture key-entered data. EDC systems are becoming cornerstones for research. Hence, choosing an EDC system is a crucial and complex process for drug development. The best EDC system involves collecting and managing data. The goal of EDC system selection is to identify […]
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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 […]
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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 […]
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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 […]
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Real-world data (RWD) and real-world evidence (RWE) are playing an increasing role in health care decisions and now in clinical trial designs. The gold standard for demonstrating the efficacy of clinical trials since the 1960s has been randomized controlled trials (RCTs). We require at least two pivotal RCTs on the market for investigational medications. RCTs […]
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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, […]
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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 […]
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