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

OUR SOLUTIONS:

Our solutions:

1st_study

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

Study Design Scenarios

  • Evaluate the feasibility of recruitment targets.
  • Analyze alternative scenarios
Study_Design_Scenarios2
  • 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.
Study_Design_Scenarios3
  • Analyze & Identify the optimal Cost & Risk scenario.
Final_protocol

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”.
Live

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 allow enhancing proactive project management.
  • The IRT functionalities: Patient, Study, Drug supply, Cohort management, etc.
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

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.
  • Setup and update study parameters at any stage.
Study_Closure

Study Closure

  • Receive quality data for the study in 1 hour.

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