Clinical Research

What is a Clinical Trial Management System (CTMS)

A CTMS is a customizable software system to manage the clinical trial data generated by pharmaceutical and biotechnological companies. Starting from planning of the research proposal to the preparation, conduct, and report generation, a CTMS maintains and manages the up to date clinical trial data.

The early phase clinical trial data is managed and maintained manually or through simple open source systems as the number of participants and tests are small. As clinical trials grow larger and more complex, the difficulty in maintenance and management of the data increases and data tracking would be lost. Hence, the need of an automatic system for managing and maintaining the clinical trials came into existence, the Clinical Trial Management System.

A baseline CTMS can perform budgeting, patient management, report generation etc but as specific requirements of the sponsor companies differ from trial to trial, customizable CTMS was developed. Sponsor companies can maximize the potential of CTMS by using them in innovative ways to cut the time and costs required to take a drug through development. The customization can be applicable to but not limited to project management, budgeting and financials, patient management, investigator management, EC/IRB approvals, compliance with U.S. Food and Drug Administration (FDA) regulations, and compatibility with other systems such as data management systems, electronic data capture, remote data capture, and adverse event reporting systems.

In the early days of CTMS, the pharmaceutical and biotechnological (sponsor) companies were very conservative in using the CTMS technology for maintenance and management of clinical trials because of concern over the security of the clinical trial data and the safety of intellectual property. But the advanced versions of CTMS performs major role in the clinical trial management. CTMS reduces the communication period for a multi centred trial where, in the past, this process would involve running reports, reviewing and aggregating output from other reports, reformatting, and sending to the client via email; a lengthy and far from ideal situation. CTMS enables the sponsor/client to log in at any time and from anywhere to monitor the trial progress by individual protocol, investigative sites, etc. CTMS enables the limiting the access for data entry, data management process to the individuals involved in the trial conduct. This ensures the security, integrity and validity of the clinical trial data.

In one of its publications, a CRO states that, “At present, CTMS appears to be a technology that has now come into its own, proving to be an important enabling tool in the management of the large complex trials that have become increasingly common. However, it is not enough simply to install the system—to maximize its value a company should be innovative and progressive, looking to exploit all of its systems to support its business. Looking ahead, it seems that this technology will only become more vital for progress as trials become larger and more complex, spanning more and more populations across the globe.”

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