subject: Clinical Trial Management [print this page] Clinical trials are tests or experiments conducted in a research laboratory to check the effectiveness of a drug/ medicine, before making it available for consumption. It is the application of the scientific method to human health. There has to be a proper management of clinical trials, since these trials and experiments involve human subjects and can at times severely affect the well-being of the people involved.
Clinical Trial Management
Clinical Trial Management is a widely used term in clinical research. It refers to the technology and processes used in the management of clinical data, to produce a high-quality database. It is the process of collecting, entering and tracking data recorded during clinical trials. To most, Clinical Trial Management refers to a standard driven process led by a project manager and backed by a team of researchers.
The Clinical Trial Management Team handles the work involved in clinical trials. This team is like the lifeblood of the core initiative, headed by a sponsor who is the driving force. The members of the team includes dedicated, qualified and experienced Clinical Research Associates (CRAs), backed by excellence in scientific knowledge and experience in the efficient handling of clinical trials.
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The growth of technology and the pace, at which science is influencing the medical world, has resulted in the birth of customizable software to assist in Clinical Trial Management. This is known as the Clinical Trial Management System (CTMS). The CTMS is used by the pharmaceutical and biotechnological industries in the smoother operation of clinical trials. It is of great use as it helps in managing the huge amount of data work involved in the clinical trial operations.
Advantages of a having a Clinical Trial Management System:
- Assists in planning and preparation of data involved in clinical trials
- Acts as a digital dashboard for clinical trial managers
- Helps track deadlines and milestones for regulatory approvals or issue of progress reports
Investment in CTMS helps in better management of data, cost cutting and better communication, which is very much essential in the complicated arena of clinical trial undertakings.
High cost of management
Secure technology solutions are needed to improve the efficiency level of clinical trials. These solutions will improve relations between clinical researchers and ease the exchange of information across boundaries. However, some of the existing technologies have adverse risks involved. Divergent data standards place crucial information beyond easy reach. A standard technology platform needs to be in place, without which the clinical trial management is a little hard to access as per requirement.
