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 […]

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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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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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The eTMF (Electronic Trial Master File) plays a crucial role in clinical trials and ensures that the trial has been managed successfully by the sponsor, investigators, and the Institution. Regulatory agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) developed initiatives to use technology that could help both expedite the […]

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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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Drug developers should ensure that the data submitted to regulatory bodies is definitive from an ethical point of view. It helps to make efficient treatment decisions and ultimately affects patient health. For this, the quality of clinical trial data is crucial. To achieve this quality data, researchers need to have proper data management in clinical […]

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Clinical data management (CDM) is a critical tool that helps to generate high-quality, reliable, and statistically sound data from clinical trials. Drug companies produce reliable data to win regulatory approval for new medications. Therefore, for a clinical trial to advance the drug development process, an effective CDM is essential. What is Clinical Data Management (CDM)? […]

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