Clinical trials are a very important phase in the development cycle of any new medication or treatment. They are instrumental not only in helping treat diseases but also in finding new ways to detect and diagnose illnesses. To put it simply, clinical trials show medical researchers what works and what doesn’t.
When planning and conducting clinical trials, researchers and administrators need various tools and services to help them. Clinical trial supply companies source these materials and provide the necessary services to help conduct clinical trials. What does it take to ensure that these tools and services are managed efficiently? Let’s take a look.
Table of contents:
- What is clinical trial supply?
- How do you manage clinical trial supply?
What is clinical trial supply?
Clinical supply, or clinical trial supply, is the supply of materials and services required to conduct clinical trials. Clinical supply commonly involves the collection and delivery of biological specimens (including safe transportation of toxic or infectious materials), drugs for investigation, trial, or patient medication purposes, study materials, and trials kits.
The clinical trial supply process can also involve providing expert assistance with permit applications—import permits, health ministry authorizations, to name a few—fulfilling customs pre-clearance, and arranging for temperature-controlled transportation, when required.
Clinical supply companies, like Client Pharma, specialize in providing clinical trial management services. They ensure that the right supplies reach the consumers, safely, efficiently, and on time.
How do you manage clinical trial supply?
Every efficient supply management strategy covers five essential pillars:
Forecasting production needs
Before beginning to act on a supply order it’s important to first prepare a forecast of the materials, API, packaging components, and third-party resources that will likely be required to complete the order. Having a broad forecast will help you prepare for changing eventualities in the trial.
Planning and tracking
A plan needs to be created that details the logistical pre-and post-production activities needed to deliver materials to the site. Many pharma consulting firms suggest that companies create a plan detailing the logistical pre-and post-production activities where materials are needed to be delivered. Project management tools help with assigning duties to the various teams and individuals involved with the logistical operation, while supply tracking tools can help stay abreast of the material’s progress through the planned route.
Preparing for re-supply
A carefully prepared re-supply plan will detail contingencies for various eventualities that may arise over the course of the trial. It will make allowances for any sudden increases in demand or last-minute inventory changes. When the services of clinical supply organizations, like Client Pharma, are engaged they will factor in and explain any costs associated with possible re-supply requirements.
Creating a distribution schedule
Distribution schedules for trials usually depend on the dosage and frequency of the study drug administered. Some trials are single dispensation only i.e. one trial kit contains all the necessary materials for one subject’s participation. Vaccine trials are a good example of single dispensation.
Other studies might require multiple dispensations, which would mean packaging and distributing trial materials many times during the study. A complete distribution plan also takes into consideration the factors affecting transportation from the supply depot to the study site and the different quality and cost options available.
Understanding the risk
Developing a comprehensive risk matrix is essential when preparing and supplying clinical materials. A risk management and mitigation report ensure that the organizations and people involved with the supply process are well educated about the issues involved, and have the time to strategize and mitigate these risks before they occur. When it comes to clinical trial supplies, forewarned is always forearmed.
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