Investigational Product Logistics
Logistics in clinical trials, especially concerning investigational products (IP), are crucial to ensure the safe, efficient, and compliant handling of drugs or devices being tested. Here are some key aspects we always consider:
Regulatory Compliance: Ensure compliance with local and international regulations regarding the handling, transportation, and storage of investigational products. This includes Good Clinical Practice (GCP) guidelines and local regulatory requirements.
Packaging and Labeling: Proper packaging and labeling of investigational products are essential. They must be clearly labeled to indicate the contents, dosing instructions, batch numbers, expiry dates, and any cautionary information.
Storage and Handling: Temperature-sensitive products need to be stored under appropriate conditions, often specified by the manufacturer or study protocols. This might involve refrigeration, freezing, or ambient temperature storage.
Transportation: Secure transportation to and from clinical trial sites is vital. Depending on the nature of the investigational product, special arrangements might be needed, such as using temperature-controlled shipping methods or specialized couriers.
Inventory Management: A robust system to track inventory, monitor usage, and ensure accountability is crucial. This includes managing supplies at various trial sites, recording receipts, distributions, returns, and destruction.
Distribution to Trial Sites: Timely and accurate distribution of investigational products to trial sites is essential to maintain the integrity of the study. This often involves coordination with multiple parties, such as couriers, customs (for international trials), and local staff at the trial sites.
Returns and Destruction: Managing unused or expired investigational products involves established procedures for returning unused IP or proper destruction following study completion or expiration.
Documentation and Record-Keeping: Maintaining detailed records of all aspects of investigational product logistics is critical for audit purposes and compliance. This includes records of shipping, receiving, inventory, and any deviations or discrepancies.
Emergency Procedures: Plans for unexpected events, such as product recalls or temperature excursions during transport, should be in place to ensure rapid response and the safety of the investigational product.
Training and Oversight: Personnel involved in handling investigational products should receive appropriate training to adhere to protocol requirements and safety measures. Regular oversight and quality control checks are essential to ensure compliance.
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