CTAMS is the CTMS that helps at each step of the trial


Our solutions:


The 1st study concept

  • With limited study information, make a rough estimate of the demand in supplies by running simulations and prepare a production pre-order.

Study Design Scenarios

  • Evaluate the feasibility of recruitment targets.
  • Analyze alternative scenarios
  • Analyze and compare the impact of changes in clinical design and study assumptions on the drug supply management and related costs, on the production schedule and distribution plans.
  • Analyze & Identify the optimal Cost & Risk scenario.

Final Protocol

  • Identify potential supply strategy.
  • Confirm the optimal supply chain configuration and distribution plan.
  • Confirm the number of supplies to produce.
  • Prepare a “Production Order”.

Study goes live

  • Manage the batches.
  • Manage user accounts (via IRT or data transfer).
  • Add IRT countries and manage sites.
  • Review the feasibility of recruitment targets and analyze alternative scenarios.
  • Control and adapt the supply strategy by using real-time study data.
  • Update the distribution plan.
  • Review & plan subsequent production campaigns.
  • System alerts enable enhanced proactive project management.
  • The IRT functionalities: include Patient, Study, Drug supply and Cohort management.
In case of issues with recruitment investigate the impact on production planning and costs created by low recruitment or high screen failure rate.

Changes management

  • Analyze in a safe mode (in investigational environment without impact on production) the impact of potential changes (protocol amendment, production delays, etc) on supplies management.
  • Share and discuss the analysis with different teams internally.
  • Identify the best strategy to proceed with.
  • Setup and update study parameters at any stage.

Study Closure

  • Receive quality data for the study in 1 hour.

Want to know more on ClinVision? Let us schedule a demo!

error: Content is protected !!