The clinical trial management system is a critical set of tools for properly planning, monitoring, and tracking your clinical research portfolio. This customized, all-inclusive project management application guides the research team from study launch through enrollment and monitoring to study closing.
There are eight CTMS characteristics.
The CTMS is a combination of eClinical technologies that work best when used together:
- Contact Management – Sites and Teams
- Monitoring and Calendar
- Analysis Milestones and the eTMF Project Plan – Tasks and Document Management
- Contract and Payment Reporting System, Business Analytics Subject Tracking, and EDC Integration Visit Report Writing and Letter Writing
The Benefits of CTMS
Having access to credible, up-to-date research information
Access to accurate and up-to-date trial information was one of the issues our team faced in past roles administering clinical trials directly for sponsors and CROs. High-level data, such as an updated site roster, and more specialized data, such as startup tracking or site visit schedules, were sometimes difficult to get. This is a terrible method of doing research. The research team can carry out their responsibilities and make informed decisions by using a CTMS system, which provides transparency and consistent access to study data.
The CTMS is an excellent place for research team members to collaborate, as well as for teams (such as sponsors, CROs, and sites) to cooperate. Team members may collaborate on a single task for the same research, such as study launch, knowing that everyone in the team has access to the most current data. Collaboration among sponsors, CROs, sites, and other vendors is another approach to share the cost of keeping research monitoring data accurate.
The CTMS is a one-of-a-kind productivity tool that helps your busy research team organize, manage, and monitor the study more effectively. An electronic visit report writing tool, for example, may automatically incorporate information about your visit (study, location, date, investigator, monitor name, etc.) and check that you have completed all required sections (Word cannot do this). Depending on your contracts, the Payment function may automatically create site payment monitoring data when subject visits are marked as complete.
The CTMS openly supervises study launch, screening and enrollment, document collection, site visits, monitoring reports, subject visit completion, action items, and issue management, among other critical study management components. Dashboards and data reports provide performance grading and visualizations for a single study or aggregated views of several studies.
Selecting the Best CTMS
The following are some common considerations to consider while assessing e-clinical systems and selecting the appropriate clinical trial management system for your needs:
Set of Functions
Are there any specific feature requirements or study management aches and pains that the solution must address?
Personalization & Adjustability
Is it necessary for the CTMS to adapt to your company’s processes and policies in terms of field picklists, unique tracking fields, and even customized planning and tracking displays (rather than constructing a new spreadsheet tracker)?
Simple to Use
Do you need an immediate system for your group?
Validating and Adhering
Do you plan to use the CTMS as a store for regulated data, such as electronic visit reports or site-critical documents? In this situation, a certified system with 21 part 11 controls is required.
Is it critical that the study management system be supported by a help desk that is knowledgeable with clinical trials? Do you want your CTMS provider to provide professional services as well as client management?
Are you looking for a solution with transparent pricing that can scale up and start small? Do investigations added to the CTMS entail additional costs? Is there a payment required to set up the workspace? Is a multi-year contract required? Do you need any more services now that you may need in the future?
CTMS and conformity
Here are a few critical CTMS compliance elements, including support for 21 CFR Part 11:
A paper trail
The CTMS should produce a detailed audit trail for all data changes made in the system, including who made the change, when it was done, and the old and new values.
Procedure for Archiving
Even though it is occasionally appropriate to remove items from the system, the CTMS should archive data rather than destroy it. The main difference is that deleted data cannot be retrieved, however archived data can. Archival enhances protection when data removal attempts are done deliberately or maliciously.
The CTMS should enable electronic signatures on documents that are relevant to the regulatory demands of your study. Much of the CTMS planning and monitoring is done to guarantee the smooth and effective execution of the research, but regulatory organizations may not be interested in it (for example, the study project plan with target vs. actual milestone dates). Electronic visit reports, document management, and eTMF, on the other hand, are important and should support electronic signatures.
The CTMS should have controls for password expiration, idle session expiration, and account lockout. The system should need users to be approved and authenticated.
CTMS vs. EDC
CTMS and EDC, which are complementary products, are used in the majority of clinical trials. While CTMS focuses on the project management aspects of the clinical trial (such as initiation, paperwork, payments, and monitoring), Electronic Data Capture (EDC) focuses on patient data collection. The systems do interact, and incorporating some of the EDC data into your CTMS is beneficial. Some of these categories include high-level screening, screen failure, and enrollment data. The CTMS generally preserves anonymised subject data in order for the research management team to monitor enrolment at a high level and use that information for site payment monitoring, visit report preparation, and so on.
Actual visit dates, as well as subject visit status and dates.
Data collection status, including data evaluation, verification, and/or permission.
Date and status of each participant’s participation in the study (completed, stopped, etc.).
CTMS or Excel?
Clinical research trackers composed of spreadsheets and worksheets are often utilized. Worksheets make data input, display, and manipulation quick and easy. Worksheets for clinical trial management are important, but as your team and research grow and your company seeks to decrease risk via quality and compliance, the limitations of these tools become apparent. The following are some advantages of using a CTMS over worksheets:
Collaboration with User Roles
The CTMS provides a secure environment in which team members may interact in a controlled environment where users can be restricted to certain data views and/or studies.
Consistent, Integrated, Secure, and Reliable Data The CTMS provides a data warehouse that can be implemented reliably across data perspectives inside a study and across studies.
To guarantee that only authorized personnel have access to data, the CTMS provides controlled user accounts. Because of redundancy, backups, and high availability cloud computing technologies, the data is always available when you need it.
While your team is engaged in study management responsibilities, the CTMS seamlessly executes controls for 21 CFR Part 11 compliance. Controls include audit trails, electronic signatures, data archiving, and user account limits, to name a few.