Our Integrated Approach

For sites that are able to use a Central IRB, we are able to complete each site's application on the sponsor's behalf, and then stay on top of IRB deadlines and approval expirations to make sure that any IRB-related delays are avoided. We are able to work directly with the Central IRB to answer questions that arise during the study, and effectively work on AE/SAE/Protocol Violation submissions on the sites behalf. =

At the end of the study our team can notify the IRB of study close-out as required by regulations, and ensure that each site files the required IRB acknowledgements in the regulatory binder.

For sites that are required to use a local IRB, we can assist the site with their submission and remind them of mid-study and study closeout submission deadlines. 

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Abigail Allen

Abigail Allen

Senior Director, Clinical Affairs