Clinical Trial Management System

A clinical trial management system ( Clinical Trial Management System; CTMS ) is a software category that is applied in the biotechnology and pharmaceutical industry to support the management of clinical trials. Using a CTMS the study manager and the study team is assisted in the planning, preparation, implementation and evaluation of clinical trials. In part, the data base of the CTMS is associated with a business intelligence system, as can be that the study data with data from other data systems linked and evaluated in the company.

Functions

The exact functionality of a CTMS ' differs from product to product. In addition, the requirements for each implementation are different, so that many of CTMS solutions have profound configuration options. The functionality of a CTMS intersects sometimes with others used in the clinical development of computer systems, such as Document Management Systems, Electronic Data Capture, IVRS, Adverse Event Reporting.

Typical features of a CTMS:

  • Address and contact data management
  • Subjects and patient management
  • Randomization
  • Case Report Form (CRF ) Tracking
  • Clinical Supply Tracking
  • Clinical Cost Tracking
  • Document Tracking
  • Reporting

Through the use of Internet technologies and the implementation of the software as a centralized web application geographically dispersed study team can access a common database. Sales representatives have access to the central student management system via a secure wireless connection (eg UMTS, WLAN). To allow you to work without an existing data connection, some providers offer special separate software modules that can be installed on mobile devices and their database can be synchronized with the central database.

Requirements in regulated environments

Since CTM systems are used in regulated environments, must meet the requirements such as Good Clinical Practice or 21 CFR part 11, there are special requirements for the operation of such systems. In addition to the validation of system operation and the presence of appropriate work instructions a detailed training of persons involved in the use of the CTMS is essential. Due to the complexity of the systems and the global distribution of the users will find classic classroom training increasingly blended learning or pure e -learning application.

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