The Covid-19 pandemic has brought to the forefront the importance of Clinical Trials for medical treatments. To explain what they are in brief, Clinical trials are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker) is safe and effective in people. Often a clinical trial is used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment. The Clinical Trial Management System (CTMS) market is expected to reach USD 1.62 billion by 2025, according to reports. Join us on our series as we explore their importance, pain points they need to address and the best solution to meet all needs.
As you can imagine, working within such a highly regulated environment as well as managing the challenge of medical teams spread out globally, it is important to have an integrated system that allows the team to collaborate their efforts. This is where Clinical Trial Management Systems (CTMS) come into the picture. A Clinical Trial Management System (CTMS) is a software system used by biotechnology and pharmaceutical industries to manage clinical trials in clinical research. The system maintains and manages the planning, performing, and reporting functions, along with participant contact information, tracking deadlines, and milestones.
There are several advantages to using a Clinical Trial Management System (CTMS). Chief amongst them are:
· Ease of Collaboration
With the help of a Clinical Trial Management System (CTMS), it is possible to store and retrieve sensitive patient information on a secure system. The ease in organizing this data and making it available for team members to access anytime, anywhere is a definite plus. Several Clinical Trial Management System (CTMS) offer ways in which access and user permissions can be customized based on the security protocol of the organization. It also helps ensure that there is no duplication for data thus allowing for effective workload management.
· Improved operations
An efficient Clinical Trial Management System (CTMS) can help track staff effort which can help you understand which tasks can be time-consuming and if any steps can be taken to simplify them. Such an accurate breakup of effort also allows you to present streamlined budgets and help in negotiations for clinical trials. The team can also set up performance benchmarks as well as streamline the handling of additional staff or funds requests from the team.
· Reliable Financial reporting
The Clinical Trial Management System (CTMS) can also help streamline the budgeting across the organization. The program also allows for a quicker revenue recovery process with help in invoicing, tracking of any missed items, prevent payment delays, etc. further, all this information is available through a single platform thereby offering a real-time update to the decision-makers when they need it. Human errors in billing can also be reduced and it is possible to allocate the charges to their specific heads as per pre-defined conditions. In cases where the patients are research participants, the system can also integrate it into their Electronic Medical Record (EMR) system and use the information for routing the charges.
· Adherence to regulatory processes
The system offers the ability to keep track of regulatory requirements across the organization. In case of any amendments or changes in protocol, these can be accessed by all members immediately thereby ensuring compliance. Staff credentials tracking allows you to maintain the level of security needed for the trials. Additionally, some clinical trial management systems also offer the interface to connect with Institutional Review Board (IRB) electronic systems and support the team in maintaining consistency in following regulatory requirements.
· Improve the experience for patients in clinical trials.
The system allows you to select potential trial participants based on pre-defined filters and preferences. This reduces the time taken to identify potential patients to start the trials. Further, through engagement programs and easy tools to collect data from the patients, it is possible to ensure retention of the patients throughout the process which is critical to success.
In conclusion, working with a Clinical Trial Management System (CTMS) not only helps streamline clinical trials but also ensures economical and timely results that can be used for treatments. Look out for my next post where I will highlight the main challenges faced while conducting clinical trials.