How can CTMS be Beneficial for your Clinical Trials?

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From patient recruitment to data analysis, each stage plays a pivotal role in determining the success of a clinical trial. However, the traditional methods of managing these trials often need to improve efficiency and accuracy. Enter clinical trial management systems CTMS, a powerful tool to streamline the entire process. In this blog, we’ll explore the myriad benefits of CTMS for clinical trials and how it can transform the landscape of clinical trials.

What is a Clinical Trial Management System?

A software program called the Clinical Trial Management System (CTMS) offers numerous operational advantages to research teams and investigators conducting clinical trials. Clinical trial management systems support CROs in keeping up with study-based procedure planning, initiation, and reporting. Furthermore, they can oversee the entire progress of a particular experiment, handle crucial participant contact details, regulate and display vast amounts of scientific data, keep track of deadlines, apply personalized filters to the data being stored, access the data remotely, and much more.

The Advantages of Using CTMS

Availability of current, accurate study information:

Obtaining accurate and current trial information was a barrier our team experienced in our previous employment managing clinical trials directly for sponsors and CROs.  Obtaining high-level data, such as an updated site roster, or more specific data, like startup tracking or site visit schedules, proves challenging in certain situations.  This is different from how a study should be conducted.  A CTMS system allows the study team to carry out their responsibilities and make wise decisions by ensuring transparency and consistent access to study data.

Cooperation: 

Study team members may collaborate successfully within the CTMS, and it also facilitates communication across different teams (such as sponsors, CROs, and locations).  Team members can work together on a single project for the same study, like a study launch, knowing they are all using the most recent data.  Updates to research monitoring data can also be shared between sponsors, CROs, sites, and other vendors working together.

Effectiveness:

The CTMS is a specialized productivity tool that facilitates efficient study planning, tracking, and monitoring for your busy study team. Electronic visit report authoring can automatically integrate the data of your visit (study, site, date, investigator, monitor name, etc.). It can also automatically verify that you have completed the necessary sections (something Word cannot do). When subject visits are designated as finished, the Payment function can automatically build site payment monitoring records based on your contracts.

Oversight:

Using the CTMS, you can monitor and control crucial aspects of your research management, such as subject visit completion, action items, issue management, screening and enrollment, document collecting, site visits, monitoring reports, and study initiation.  Dashboards and data reports offer aggregated views of several studies or individual research visualizations and performance scores.

How can a Clinical Trial Management System transform Clinical Trials?

A CTMS can always continue to transform your trial management, regardless of your a, dramatically, dramatically in terms of technical competence, role in study management, or even the number of studies or sites in your program. You can always have a little experience with clinical development. As everyone knows, statistical significance is crucial when obtaining regulatory bodies to accept our items! Here are ten ways a CTMS solution can change how you handle clinical trials.  

Aggregation:

• CTMS allows for data aggregation in a database, enabling better decision-making and quicker retrieval.

• Central Vendors: CTMS allows single sign-on access to central vendors, eliminating the need for multiple data retrieval and documentation passwords.

Mobile Access:

• CTMS, with a mobile app, allows easy access to study information, especially for CRAs on the move and study managers juggling work/life balance.

• Language localization preferences and directions to the site can be easily managed within the CTMS app.

Milestones:

• CTMS allows sponsors to define and track study milestones, allowing visualization of upcoming and past milestones.

• Setting up milestones in a CTMS allows teams to see progress and satisfaction.

Study Patients:

• CTMS provides real-time updates on patient enrollment, status, and recruitment.

• It integrates data from EDC or IxR systems, transforming trial management by providing real-time updates.

Protocol Deviations:

• FDA and ICH require centralized tracking of protocol deviations and classification.

• CTMS allows centralized tracking, owner definition, and routed review and sign-off on deviations.

• CTMS can identify trends and triggers that would not be possible without a CTMS.

Visit Report Documentation:

• CTMS allows CRAs to put critical information into the CTMS and generate reports.

• It streamlines work for CRAs, allowing them to view open activities from previous visits, the status of protocol deviations, and generate a report.

• Once a report is completed within the CTMS, the approved version is filed in the eTMF under the correct site in the right folder.

Resourcing:

• CTMS allows for resourcing beyond study teams, including central labs, central IRBs, IP supply providers, etc.

• A good CTMS allows sponsors to assign Study Team members and percentage allocations in a manner that provides visibility across the study.

Dashboards and Visualization:

• CTMS can be the “hub” of information for departments and management responsible for oversight and execution of development.

• Sponsors should consider implementing their own CTMS “light” so that select CTMS data can be integrated from the CRO for real-time information when needed on the go.

Email Reduction:

• Modern CTMS eliminates the need to email visit reports and letters between CRA and managers.

• It allows viewing study status on a mobile device, reducing unnecessary emails.

How do you Select the Appropriate CTMS for your Clinical Trials?

When examining clinical systems and choosing the best clinical trial administration software for your requirements, keep the following points in mind:

Features List:

Does the system need to address study management issues or feature requirements?

Adaptability and Personalisation:

Does the CTMS need to adapt to the procedures and guidelines of your company in terms of field picklists, unique tracking fields, and even specially designed planning and tracking displays (instead of creating an additional spreadsheet tracker)?

Usability: 

Does your team require a system they can use right away?

Verification and Adherence:

Do you intend to use the CTMS as the official record system for data subject to regulations, like electronic visit reports or site vital documents?  If so, it will be essential to have a verified system with 21 part 11 controls.

Encouragement:

Is a help desk knowledgeable with clinical studies that must support the study management system?  Do you want your CTMS supplier to offer you the choice of professional services and client management?

Price: 

Are you trying to find a small-scale, transparently priced solution that can grow with you?  Does the inclusion of studies in the CTMS come with an extra cost?  Does the workspace have an initial fee to launch it?  Is a multi-year contract necessary?  Are there any more services you should consider now that you might require in the future?

Wrapping-Up

In conclusion, cutting-edge software solutions have been the most practical in clinical research and pharmaceutical industries for several years. It’s hardly surprising that clinical trial management solutions are becoming increasingly popular. After all, these specific software solutions offer several benefits that modernize and improve trial-based processes, from finding possible subjects to following protocols to keeping an eye on the status of a particular study. 

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