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


Our solutions:


At stage: The 1st study concept, the users can:

  • With limited study information, make a rough estimate of the demand in supplies by running simulations
  • Evaluate the feasibility of recruitment targets
  • Analyze alternative scenarios
  • Prepare a production pre-order

At stage: Study design evolution, the users can

  • 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
  • Review the feasibly of recruitment targets and examine alternative scenarios
  • Tune up recruitment expectations following feasibility analysis by confirming sites status
  • Identify supply configuration
  • Identify potential supply strategy

Stage: The Protocol is final, the users can:

  • Confirm the optimal supply chain configuration and distribution plan
  • Confirm the number of supplies to produce
  • Plan production campaigns
  • Prepare a “Production Order”

At Stage: Setup

  • The IRT is configured

Stage: Study is live, the users can:

  • Manage the batches
  • Manage user accounts (via IRT or data transfer)
  • Add IRT countries and manage sites
  • Review the feasibly of recruitment targets and analyze alternative scenarios
  • Control and adapt the supply strategy by using real-time study data
  • Update the distribution plan
  • Plan subsequent production campaigns
  • System alerts allow enhancing pro-active project management
  • The IRT functionalities:
    • Patient management
    • Drug supply management
    • Study management

In case of issues with recruitment, the user can:

  • Investigate the impact on production planning and costs created by low recruitment or high screen failure rate

Changes management, the users can:

  • 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

At any stage of the study, the users can:

  • Setup and update study parameters

Stage: Database lock, the user can:

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


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