Clinical Supply Chain Testing
Clinical trials must be performed on any drug candidate prior to regulatory testing. The purpose of the trials is to ensure both safety and effectiveness of treatment in human subjects prior to the U.S. Food and Drug Administration’s approval. Currently, there are three phases of clinical trials, and at each phase, the drug candidate is tested against a placebo and/or a medication already on the market. These materials are known as the clinical supply chain.
In order to effectively manage clinical trials, the clinical supply chain must be constant. If clinical supply is delayed, the clinical trial will be also be delayed, which can have substantial financial implications related to the manufacturing process, analytical testing, clinical trials and ultimately, availability on the market. Laboratory testing must be performed on all materials associated with the clinical supply chain, such as capsule shells, placebo, drug product and packaging. The final packaged product is then tested for release and placed on stability to determine storage and expiration of the final packaged product.
Eurofins Lancaster Laboratories has experience with a comprehensive range of testing services to support the clinical supply chain, including:
- Release Testing of Clinical Supplies/Raw Materials
- Active Pharmaceutical Ingredients (API)
- Method Development & Validation
- Identification and Clinical Release Testing
- Comparator Product Testing
- Stability Studies