A Process for Successful Mid-study Changes

changes in clinical trials can be challenging

Change is a constant challenge in the world of clinical studies, and it can cause both stress and delays. In our last blog, we discussed 5 tips for more effective mid-study changes. Now let’s look at the components of a successful management process for a technical change from an IRT perspective. The IRT Project Manager …

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How to Test an IRT for Your Next Clinical Trial

Regulatory requirements make the documented testing and validation of the electronic systems used in clinical trials critically important to the success of any clinical study. This is because approval authorities will reject clinical data collected by what regulators deem to be substandard means. (For examples, see 21CFRPart11 and EU Annex 11) There are two categories …

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