Agatha enables Sponsors, Hospitals (conducting Investigator Initiated Studies), and Investigational Sites, to easily manage, maintain and archive the Investigator Site File (ISF) as per the applicable regulations.
The Investigator Site File (ISF) is the set of documents that must be held by a site to ensure the integrity and compliance of the trial data. The ISF must be maintained by both the sponsor of the study and the investigational site. Some agencies require for the ISF to be archived for at least 25 years.
Agatha provides an easy way for investigational sites to ensure that they comply with applicable regulations. Agatha provides content management capabilities fully compliant with GxP regulations and FDA regulations such as CFR 21 Part 11. Investigators can easily manage documents and applicable forms through the Agatha online web interface. Review process is simplified since it can be performed directly online without the risk of using a wrong version of a document, and without the hassle of downloading and sending documents by email. Approval process is also fully integrated within Agatha (with or without electronic signature). Existing content (e.g. Investigator CV) can be reused between studies. Content can also be automatically generated (e.g. FDA 1572).
Investigators can collaborate with sponsors and directly send them the necessary information. If the Sponsor uses Agatha Clinical eTMF, an automated reconciliation process is performed in the Sponsor electronic Trial Master File (eTMF).
Also, check out how Agatha can help you manage the IRB process!