CompleteClinica is a web-based platform for the Clinical Trial Management System (CTMS). It is used to create, modify, maintain, archive, retrieve, and transmit clinical data intended for submission to the Food and Drug Administration (FDA). These data form the basis for the Agency's decisions regarding the safety and efficacy of new human and animal drugs, biologics, medical devices, and certain food and color additives. It facilitates protocol configuration, the design of Case Report Forms (CRFs), Electronic Data Capture (EDC), retrieval, and clinical data management. CompleteClinica follows the FDA Regulations defined in the Code of Federal Regulations (CFR), ICH GCP Guidelines and HIPAA Guidelines.
On the introduction of New Research Question, Manufacturer files an Investigational New Drug Application (IND), or Investigational Device Exemption (IDE) to the FDA for the Study Design review and FDA approval/rejection of application.
Clinical Lifecycle phases are implemented as six modules in the CompleteClinica.
CompleteClinica supports Study Setup through the Study Management Module.
