Agatha provides the best solution on the market to manage Institutional Review Board (IRB) process using pre-filled web forms that are easy to complete by the sites and by the IRB members. It is estimated that institutions using Agatha are cutting the IRB preparation and review time by more than 50%.
Agatha fully supports the IRB boards to fulfill their goals to protect human subjects, to ensure that the benefits of a study outweighs its risks, and to ensure that the investigators are qualified to conduct a study.
All types of IRB reviews are supported by Agatha (New study applications, amendments and continuous reviews).
IRB web forms are automatically generated in Draft by the system as new investigational sites are added to a study (prior the beginning of the trial for the site) or for periodic reviews.
Site personnel can update the Draft of the IRB form and send it to the IRB committee for review. The IRB committee can access all of the necessary information to make a decision directly from the form (e.g., informed consent documents and investigator brochures), collect the list of attending committee members and record the outcome of the review.
The web form can be converted as PDF in the format expected by the FDA and other regulations.