What is the clinical trial management system?
A clinical trial management system (CTMS) manages all operational aspects of a clinical trial from study initiation to study closeout. Research sites, site networks, health systems, academic medical centers, and cancer centers use a CTMS to centralize data about staff, subjects, protocols, finances, and billing, among many other topics. Serving as the center of operations for research, a CTMS streamlines study conduct and increases visibility throughout the site’s whole portfolio of research.
The tools you need to efficiently plan, organize, and monitor your clinical research portfolio are in the Clinical Trial Management System. Through enrollment, monitoring, and study close, the research team can use this specialized, all-inclusive project management tool from the beginning to the end.
Understanding Clinical Trials
Before we plunge into the depths of CTMS, it is imperative to understand the context in which it operates. Clinical trials are rigorous, controlled studies that evaluate the safety and efficacy of medical interventions, ranging from pharmaceuticals to medical devices and behavioral therapies. These trials follow a carefully designed protocol outlining the study’s objectives, methodology, participant eligibility criteria, and data collection methods.
The lifecycle of a clinical trial involves several phases, from the preclinical stage, where a potential intervention is tested in the laboratory, to the subsequent phases involving human subjects. Clinical trials are categorized into phases I-IV, each serving a specific purpose:
First Phase: Assessing safety and dosage in a small group of healthy volunteers.
Second Phase: Evaluating the intervention’s efficacy and side effects in a larger group of patients.
Third Phase: Confirming efficacy, monitoring side effects, and comparing the intervention to existing treatments.
Fourth Phase: Post-marketing surveillance to monitor the intervention’s long-term effects on a larger population.
The Advantages of 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. Receiving high-level data, such as an updated site roster or more specific data, like startup tracking or site visit schedules, proved 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 duties and make informed decisions by providing transparency and consistent access to study data.
Teams Work
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. An electronic visit report authoring tool 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.
Selecting the Appropriate CTMS
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 your company’s procedures and guidelines regarding 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?
Observance and CTMS
The following are some crucial factors to take into account when complying with a CTMS, including support for 21 CFR Part 11:
Audit Trail
The CTMS should thoroughly document all data changes made to the system, including who modified them, when they were made, and the old and new values.
Policy for Archives
Records should occasionally be deleted from the CTMS; however, the CTMS should be archiving data instead of erasing it. The primary distinction is that deleted data cannot be readily restored, but archived data can. Archival strengthens defenses against malevolent or accidental efforts to erase data from the system.
Digital Signatures
The CTMS should support electronic signatures for documents pertinent to your study’s regulatory needs. Much of the CTMS’s planning and tracking ensures the analysis is carried out well, but it might need to be more relevant to regulatory bodies (e.g., the study project plan with goal vs. actual milestone dates). Electronic visit reports, eTMF, and document management are crucial, nevertheless, and they should allow electronic signatures.
Account Management
Users should be authorized and authenticated to access the system, and the CTMS should include controls over the expiration of passwords, the locking of dormant accounts, and the expiry of idle sessions.
EDC vs. CTMS
The majority of clinical trials include both CTMS and EDC since they are complementing products. While CTMS concentrates on the clinical trial’s project management elements, such as documentation, payments, monitoring, and startup, Electronic Data Capture (EDC) is focused on gathering patient data. Connecting a portion of the EDC data to your CTMS is advantageous because the systems interact. These domains consist of:
Enrollment data, screen failure, and high-level screening. Typically, the CTMS maintains anonymized subject records used by the research management team for various tasks, including writing visit reports, monitoring site payments, and high-level enrollment tracking.
1. Subject visit progress, providing the dates and status of the actual visits.
2. Status of data collection, including data assessment, validation, and approval.
3. End of study status (finished, stopped, etc.) and date for every participant.
Conclusion:
To sum up, the Clinical Trial Management System is crucial in launching medicinal interventions. Its diverse responsibilities in protocol formulation, site administration, patient recruiting, and data monitoring guarantee the accuracy and effectiveness needed in the dynamic field of clinical trials.
As technology develops, CTMS must embrace new ideas like blockchain, artificial intelligence, and decentralized trial models. For CTMS to be seamlessly integrated into healthcare research in the future, it will be imperative to navigate the obstacles of interoperability, data security, and regulatory harmonization.
CTMS is a dynamic force advancing clinical trials and improving patient outcomes globally. It is more than just a system.
