A Seamless Clinical Trial Management System (CTMS)
Connect CTMS seamlessly with DATATRAK’s EDC, or utilize powerful API’s that give you the ability to connect our CTMS with outside programs or processes, allowing you to achieve truly unified data. To reduce redundant data entry, our Imports Manager allows you to import patients, personnel, products, site, vendor and deviation data directly into CTMS.
Insight Driven Trial Optimization
Utilizing our robust data repositories, CTMS by DATATRAK allows you to significantly optimize your workflow with insight driven data, ultimately empowering the users to accelerate the progress of trials. Data is perishable, and degrades over time, but with DATATRAK, data is delivered proactively in real-time, ensuring the important decisions you make are reached with the most up-to-date information possible.
Efficiency From Start to Finish
Our Clinical Trial Management System provides 360 degree insights into the operational data of clinical research. The system maintains and manages study planning, start-up, study performance, study reporting and regulatory submission. DATATRAK CTMS also includes functions for site feasibility, and the tracking of action items and milestones, while acting as a repository for business operations and contact information.
Study Planning and Start-up:
- Site, Personnel, and Vendor Repositories aid in the site identification processes, and provide collaborative spaces where both CRO’s and Sponsors can store important documents essential to vetting sites, vendors and investigators, for current and future studies.
- Track site and study progress using milestones that can be created, updated and reported on at both the study and site levels.
- Utilize Enrollment Reports to track important metrics regarding site performance.
- Manage group communications externally or internally within your workgroup or organization by setting triggers for expected response times. If the timeline is missed, receive notifications that a response has not been provided.
- Easily view information concerning various payment triggers that are configured in the system with our Payments Manager.
- Create a unique site visit plan for each study. Projected visits appear on the Dashboard calendar for planning and forecasting.
- Streamline the creation of monitoring reports by configuring a collection of templates that are easily duplicated and tailored.
- Submit site visit monitoring reports electronically through CTMS. Visit activity and site data can automatically populate if connected to DATATRAK’s EDC.
- Track site payments for both individual site specific budget items, as well as visit payments, all populated in real-time. Approved totals owed to each site can be viewed and paid, while tracking payment due dates and identifying late payments.
- Store, record and track deviations of protocol or noncompliance associated with a study at a high level, providing an easy view of select information to identify deviation trends quickly.
- Approve deviations and monitoring reports using the approval workflow tools, which can be tailored by study and include signature and lock options.
- Utilize fully exportable standard and ad-hoc reports to gain clear insight and analysis of your study.
- Simplify your submissions with our Regulatory Submission Manager, which helps you create, track, and template submissions to regulatory authorities. Track and store relevant documents in a version controlled environment, and create easily customizable checklists to manage your tasks. Reduce redundancies by sharing data across multiple submissions.
- Define Regulatory Bodies and associate them with common sets of requirements based on categories such as therapeutic area, or type of study, then easily reuse these standard sets in future trials.
Distinguishing CTMS 360 from the Competition
CTMS 360 redefines industry standards. This white paper gives an in-depth look at the power of CTMS 360 compared to the competition.
CTMS 360: Built from a User’s Perspective
See a comprehensive demonstration of CTMS 360’s innovative solutions and functionality that were built with your needs in mind.
Streamline the Creation of Monitoring Reports in CTMS 360
See how CTMS 360 uses innovation to eliminate many of the tedious and redundant tasks needed to generate reports.
The Next Step
If you’re ready for more information, a DATATRAK expert is ready to help you to get started.
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