Risk management

Clinical trial supply chain is inherently complex. Even small details such as expiration dates, bulk availability and specific country labeling must be taken into account. In addition, trial design (e.g., stratification, randomization, titration), patient enrollment, dropouts, and drug distribution are factors that can have a major impact on the forecasting of material needs.

The complexity of demand forecasting creates certain risk factor being unable to supply the right drug to the right patient at the right time. In order to reduce this risk, various techniques can be used, including increased overage, increased shipment frequency, dynamic supply rules (e.g., shipping to site after randomization), and frequent real-time inventory tracking. As each of these approaches implies a certain cost, our aim is to find the right balance between such costs and goals for each trial.

At COREX we have developed our own trigger-based method utilizing key risk indicators for the following strategic areas: 
  • Investigational Medicinal Product (IMP) related risk area: any available information about the physico-chemical properties of active ingredient(s), the manufacturing process of active ingredient(s) and of investigational medicinal product(s), pharmacokinetic, pharmacological and toxicological properties of the investigational medicinal product(s), and the requirements for the labelling and packaging of the IMP.
  • Trial design related risk area: complexity of trial design, trial population (e.g. vulnerability, morbidity), therapeutic area (e.g. difficult recruitment in rare diseases), sample size calculation, predicted recruitment ratio and dynamics.
  • Operational risk area: study budget, deadlines, staff availability and study specific training, study management team and the magnitude of third-party involvement, clinical trial supply processes and management, clinical site set up and infrastructure, laboratory setup, lines of reporting and/or communication.

With the use of COREX risk-management methodology based on the historical data analyses we strive to mitigate not only the risks concerning site-availability and on time IMP-supply, but go beyond supply management and have created a specialized cold-chain analyzing tool, that helps us to choose proper packaging equipment based on site-location, external temperature, seasonal variabilities and drug stability data.

Contact us to learn more about our risk management practices today!

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