Clinical trial material management is an important but not often publicized issue in clinical trials. Clinical trials are a crucial part of the healthcare industry. Whether you’re a drug manufacturer or a medical device producer, you’ll need to undergo clinical trials before you can release your product to the market. Otherwise, the Food and Drug Administration (FDA) won’t approve your product. Clinical trials are a lengthy and complex process, taking years to complete.
One of the most crucial parts of any clinical trial is ensuring an adequate supply of clinical trial material. For instance, if researchers are examining a new drug’s effects on patients, they’ll need a steady supply of the drug. As a result, managing clinical trial materials is critical. This article will discuss the pillars of clinical trial management to ensure you don’t run out of materials during your research.
The Pillars of Clinical Trial Material Management
Here are the pillars of clinical trial material management. They include:
Clinical Trial Material Management and Production Forecast
Drug manufacturers produce limited drug quantities for clinical trial use. You’ll want to have a production forecast stating the current inventory and when the manufacturer will replenish the inventory. Doing so helps you properly allocate your trial materials. In addition, it prevents you from running out of supplies. The production forecast is also instrumental as it enables internal and external shareholders to be on the same page for current and future inventory positions.
Project Plan
A project plan is crucial for clinical trial success. Generally, project plans include details about pre-production and post-production activities. They give the manufacturer a timeline for when supplies are needed and how the researchers will be using the materials. You can use project management tools depending on the particulars of your study. Project plans can also include strategic information like finding secondary vendors and material inventory lots.
Re-supply Plan
Eventually, supply will run out. Researchers need to determine timely replenishing of supplies. Otherwise, the entire clinical study becomes at risk, which doesn’t bode well for the drug manufacturer. A re-supply plan can prevent supply from running out. A re-supply plan predicts patients’ needs. Moreover, it allows you to set lead times for operational units and anticipate the expiry date of investigational medicinal products.
Distribution Schedule
Once a clinical trial starts, manufacturers need to determine the trial’s needs. Some clinical trials are single dispensation trials, meaning you only need a single drug kit. However, other clinical trials require multiple shipments. Using a randomization trial supply management is a good idea for creating a distribution schedule and following it.
Clinical Trial Material Management in Manufacturing Facility
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