Supply Chain Management
A successful clinical trial is dependent on numerous factors, one of which is the effective planning and management of the clinical trial material supply chain. Ultimately patients enrolled in a trial must receive the right drug on schedule. While that overall objective is straightforward, what is often underestimated is the knowledge and experience required to make that happen. The Clinical Supply Optimization Service is a comprehensive service designed to manage, optimize and streamline the clinical supply chain from early strategy development through the enrolment, maintenance, and closeout phases of a trial.
Ideally, a clinical supply chain manager gets involved very early in the planning of a clinical trial, even before the protocol is finalized. An experienced supply chain manager can quickly grasp the objective of the study and can make clinical supply-related recommendations on protocol content. Early engagement also ensures that package design is ideal (with the patient and the research in mind) and the Interactive Response Technology (IRT) is designed, configured, and tested appropriately for medication management. Early engagement allows for the distribution network to be proactively established so timelines for importation and any special handling requirements for the clinical supplies can all be accommodated. Finally, quantities for the Investigational Product and comparator must be forecasted and optimized in order to minimize the risk that clinical supplies might negatively impact trial execution
Once patient enrollment begins, effective supply chain management must continue to make sure the inventory is in the right locations to enable patient dosing. Other activities such as maintaining the clinical supply forecast, communication with key stakeholders, metrics reporting, planning resupplies, and coordinating dating extensions are all critical to an effectively managed supply chain.
At the end of the trial, the returns and reconciliation process must be supported so that the protocol requirements are met and the trial is closed compliantly.
The Fisher Clinical Services Clinical Supply Optimization Services team is prepared to cover all of these activities associated with clinical supply chain management. The team consists of experienced supply chain managers with deep experience and expertise across therapeutic and geographic areas. The service is designed engage and work collaboratively with your clinical trial stakeholders and partners to enable successful strategic trial planning and management.
Key deliverables of the service include:
- Proactive guidance in the development of supply strategy
- Clinical supply forecasts that are robust and developed with access to sophisticated Monte Carlo simulation technology
- Ongoing maintenance of those forecasts that reflect actual data as the trial continues
- Proactive supply chain management designed to ensure clinical supplies are an enabler to trial execution
- Minimized supply chain risk, waste and complexity
- A flexible resource model which can augment internal resource
- Management of key clinical supply chain tasks that free your internal resources to focus on other crucial deliverables
- Budgetary reporting and dashboards to ensure your studies are on track from a financial perspective
The Clinical Supply Optimization team is experienced and is prepared to manage an individual study or a portfolio of studies in any stage of clinical development. We are also experienced in supply chain management of investigator-initiated trials.