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.
Study Performance:
  • 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.
Study Submission:
  • 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.

CTMS Resources

Distinguishing CTMS by Datatrak from the Competition

CTMS by Datatrak redefines industry standards. Take an in-depth look at the power of CTMS by Datatrak compared to the competition.

CTMS by Datatrak: Built from a User's Perspective

See a comprehensive demonstration of Datatrak’s CTMS and it’s  innovative solutions and functionality that were built with your needs in mind.

Streamline the Creation of Monitoring Reports in CTMS

See how CTMS by Datatrak uses innovation to eliminate many of the tedious and redundant tasks needed to generate reports.

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