data management

Facilitating Dose Escalation/Early Phase Studies

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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Using Authorization Codes to Control Protocol Deviations

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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