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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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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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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An electronic informed consent (eConsent or eICF) is a principle in clinical research that a patient should have sufficient information before making their own free decisions about their medical care and participate in clinical research. Using electronic medium to manage informed consents makes the researchers job easy and regulatory authorities also recommend using eICF. Did […]

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Designing clinical trials in psychiatry is challenging compared to a regular clinical trial. Clinicians and instructors have to handle participants who are mentally ill. They have to assume numerous factors before the clinical trial, where the main issue is taking informed consent, populations, measuring end-points, etc.  There are many ethical laws and criteria for designing […]

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The protection of human rights is paramount in clinical trials, and one should design and implement clinical research ethically and scientifically. Clinical trial monitoring is essential for quality assurance to ensure the protection of human rights and the reliability and transparency of the data collection process. What is clinical trial monitoring? Clinical trial monitoring is […]

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CROs, biotechnology, and pharmaceutical companies use software to facilitate clinical trials from design to finish. Clinical trial management software includes eTMF, Clinical Data Management (CDM), eConsent, Patient Management, Electronic Data Capture (EDC), Protocol management, CRF design, and many more. The importance of this software in the new era of clinical development is increasing day by […]

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