Clinical trial management system is a software system used by biotechnology and pharmaceutical industries to manage clinical trials in clinical research. This system maintains and manages performing, planning and reporting functions, along with the relevant information of participants, like contact information, tracking deadlines, and milestones.
The system comprises of protocol development, site selection & trial preparation, subject identification & enrolment, collection, monitoring & processing of data, data analysis & reporting, pharmacovigilance, and submission for review. Data is collected during the process of trials and is stored in the database. The data is then reviewed to decide upon the safety parameter of the drug.
How is clinical trial management useful?
• Real-time Insights into Operations: It is a system that provides a central place for recording operational activity, which offers easy access to important information.
• Stronger Financial management: It supports consistency in budgeting across the enterprise and provides access to all financial information.
• Increased staff efficiency: It reduces duplicate data entry, and thus only relevant information is present in the software. This saves time for the staff and increases accuracy and consistency of data.
Clinical trials are experiments done in clinical research to determine medicines or procedures that will/will not benefit the patient. Chronic heart ailments, cancer, diabetes, stroke, and arthritis have long lasting effects, persistent for more than three months after treatment. Globally, chronic diseases kill more than 38 million people each year. Cardiovascular diseases account for most deaths, approximately 17.5 million people annually, followed by cancers (8.2 million), respiratory diseases (4 million), and diabetes (1.5 million). These four groups account for 82% of the chronic disorder mortalities. New medicines and procedures need to be developed to tackle these diseases. In addition to this, communicable diseases, like Ebola, swine flu, etc. still do not have effective cures. Owing to all these factors, the number of clinical trials performed has increased significantly in the past decade.
A report by Mordor Intelligence, a market research firm estimates double digit growth rate for Clinical Trial Management Market
Increasing incidences of chronic diseases, increase in R&D to implement localized research programs, increased clinical research outsourcing, and implementation of clinical trials by Contract Research Organizations and Synchronization of Hospital Information System (HIS) with CTMS are some of the factors driving the market growth.
Hurdles for Clinical Trial management Market: Data security issues, lack of qualified and skilled labor to handle CTMS, increasing rate of clinical trial failure in Phase II and Phase III, and high cost of customized CTMS are some of the factors hindering the growth of the market.
Way Ahead: The future involves development of advanced software with high accuracy and efficiency, which will likely provide lucrative opportunities for market growth.