A Complete Overview of CTMS Software
A Complete Overview of CTMS Software
The Clinical Trial Management System is a suite of tools for planning, managing, and tracking clinical studies. It is a complete project management tool that takes the Clinical research team from start to finish.
Feature of Clinical Trial Management Software:
The CTMS is a set of eClinical technologies that function best when they all work together:
Access to current study information
Access to accurate and up-to-date trial information was difficult for our team when working directly for sponsors and CROs. For example, an updated site roster was challenging to get, as were startup monitoring and site visit schedules. This wasted ample time. To accomplish their work and make sound judgments, the research team needs a CTMS solution.
Collaboration
The CTMS is a fantastic location for research team members to collaborate (e.g., sponsor, CROs, sites). Team members can work together on single research activity as a study launch, knowing they’re all using the newest data. Sponsors, CROs, sites, and other suppliers can also work together to keep research monitoring data current.
Efficiency
The CTMS helps your busy research team organize, track, and monitor the study efficiently. It can automatically check that you have finished the relevant parts (Word can’t do that). It may produce site payment tracking records based on your contracts when topic visits are finished.
Oversight
The CTMS gives transparency to research launch, screening & enrollment, document collecting, site visits, monitoring reports, subject visit completion, action items, and issue management, among other components. Dashboards and data reports visualize and score one study or several research.
CTMS and CC
Considerations for CTMS Compliance, including support for 21 CFR Part 11:
Traceable
To track any data changes made in the system, the CTMS should have a comprehensive audit trail of who made what modifications.
Archive Policy
When records are removed from the CTMS, the data should be archived rather than deleted. Data that has been preserved may usually be retrieved quickly, but data that has been erased cannot. Data erasure attempts, whether negligent or malicious, are protected by archiving.
E-Signature
The CTMS should support electronic signatures for records needed by your study’s requirements. The CTMS planning and tracking are primarily for the study’s efficiency and efficacy rather than for regulatory purposes (e.g., the study project plan with target vs. actual milestone dates). eTMF, document management, and electronic visit reports, on the other hand, are all critical and should allow for e-signing.
Account Admin
The CTMS should need user authorization and authentication, including password expiration, idle session expiration, and account lockout control.
Choosing the CTMS
To help you choose the best clinical trial management software for your needs, here are some typical factors to consider:
Feature Group
Is there a must-have feature or study management pain point?
Customization
Custom field picklists, custom tracking fields, and even custom planning and tracking views are all possible with the CTMS (an alternative to building out another spreadsheet tracker).
Utilities
Do you need a system that works right away?
Validation & Assurance
Including regulated data such as site necessary papers and electronic visit reports in the CTMS?.
Support
The study management system must provide a clinical study help desk. Do you want your CTMS supplier to deliver professional services and client management?
Cost
If so, you want a solution that can scale up and down with you. Is there a setup fee? Is a multi-year contract required? Is there anything you can do now to prepare for future services?
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