By: Vincent Puglia, RTSM Strategy | Community Director Introduction: Onboarding is vital for the smooth conduct of clinical trials in today’s dynamic environment. In a recent Veeva RTSM webinar, we explored the details of an onboarding model that demonstrates excellent sponsor oversight. This method simplifies the onboarding process and enables all stakeholders to perform well …
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Introduction A main goal of Phase 1 trials is to establish the recommended dose and/or dosing regimen of new drugs for efficacy testing in Phase 2 trials, using a detailed and monitored dose escalation process. To reach this endpoint, study designs will have many components of this process outlined in the protocol, including starting dose/regimen, …
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Introduction As Sponsors look to leverage technology in clinical trials to help maintain and control adherence to the design, methodology and all aspects of a protocol, they are often left with only two functionality options to control protocol deviations. They can leverage Soft Stop functionality where a warning message is shown, providing information that may …
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