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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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 […]

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