CTMS or clinical trial management system is very useful in an institution where a clinical research is applicable, particularly in a research hospital, cancer center, academic medical center and also in physician practices. The customizable software system is specifically used in pharmaceutical and biotechnology industries so as to manage the large volume of information used in performing a clinical trial. The system is used in maintaining and managing all operations of a clinical trial including planning, preparation, performance and the documenting of the clinical trials.
A primary function of the clinical trial management system is to keep up-to-date contact information for the concerned individuals as well as to track deadlines and significant developments including that for regulatory approval and the issuance of progress reports. The clinical trial management system provides pertinent information to the business intelligence system that serves as a digital dashboard of key performance indicators for trial manager involved in a business process such as sales, marketing and production.
A clinical trial management system came about after the amount of data obtained during the progression of the clinical trials increased. The customizable clinical trial management system eventually replaced the in-house or home made program used by most managers to handle their data at the early phase of the clinical trials. The feature is rich and the more stabilized software is provided by specialized vendors. It is made to satisfy the different needs of the managers such as patient management, operation financing scheme, compliance with goverment restrictions and laws.
CTMS must also satisfy each sponsor and simplify project management, financial management or budgeting, patient management and recruitment, investigator management, compliance with government agency rules and regulations while being compatible with data management systems in adverse event, reporting units and electronic data capture. A CTMS may be a cloud- based system and is delivered as a software. Other forms of CTMS may require dedicated servers.