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 applications.
Clinical Lifecycle phases are implemented as six modules in the CompleteClinica.
CompleteClinica supports Study Setup through the Study Management Module.
This is an integral module of CTMS, acting as a backbone for clinical studies. Study management defines the guidelines of a study plan. Various aspects of study such as Arm, Site, Therapeutic Area, Indication, Research Organization, Ward, Contact organization, etc. are managed using this module.
The outcome of the study must be documented, both in case of Normal and Adverse Events. It allows eCRF Management. CRF can be created within the application and corresponding data is entered and maintained in CRFs.
Participants of research are referred as Subject. It may comprise of patients or volunteers. This module is capable of managing the entire process of Subject Recruitment and Enrollment. All the subject details such as race, trait, etc. are maintained within the application.
Clinical studies consist of several participants and stakeholders. This module allows for User Management and User Creation. Corresponding Roles and ACLs can be assigned to users. Functions such as task allocation, task scheduling, signature, etc. can also be performed.
Allows the generation of custom reports using data sets. Queries can be fed into the query builder. Reports can be in the form of tables or graphs. It also allows for subject tracking. The major types of reports generated are as follows:
The Administration module provides various tools for application configuration. Functions such as Audit Trail, Log, Custom Field configuration, Document Attachment, etc. can specified by the administrator.
