Clinical trial supplies

Cutting High Costs

The value of some study drugs can reach tens of millions of dollars, making it essential to avoid overproduction, oversupply, and inventory expiration.  With the high costs and strict handling requirements for many biopharmaceutical products entering clinical development, the logistics of clinical trial supplies are more critical than ever.

PAREXEL’s streamlined clinical trial supply processes, led by your assigned Clinical Logistics Leader, have the experience and expertise to make sure your study drug is where you need it when you need it.  Expert management begins with the clinical trial supply strategy, and ends with returns and destruction. Integration and coordination of many third-party vendors and technical systems is needed to verify that study drugs are available in sufficient quantity and quality at the various stages of clinical distribution. Full traceability of drug supply from manufacturing to dispensation and destruction is a key for study success, as it avoids information gaps and reduces risks such as out of stock or expiration.

Dealing With Stringent Handling Requirements

Investigational Medicinal Products (IMPs) must be manufactured, stored and distributed in strict accordance with Good Manufacturing Practices, utilizing labeling and packaging that match the trial protocol. Equally important is the importation and distribution of IMPs and Non Investigational Products (NIMPs) -- such as rescue and add-on medication -- that require extensive planning.

PAREXEL’s Clinical Logistics Leader provides the knowledge and action to ensure deliveries are not delayed and to decrease the risk of expired inventory. PAREXEL also provides a worldwide network of depots and service providers such as manufacturers, wholesalers and couriers.

The Clinical Trial Supplies Advantage

• Holistic management of the entire clinical supply chain
• Global and Local expertise and experience to manage dynamics for any type and size of clinical trial
• Determines labeling requirements and global in-house label text translation capacities
• Drug production coordination on behalf of sponsor
• Distributes materials to depots, warehouses, and trial sites
• Monitors shipments and maintains inventory
• In time study start-ups and material stock at site monitoring supports a rapid patient enrolment and significantly reduced site efforts.
• Qualified and established global depot network
• Warehouse management system & entire material stock control
• Standardized return & destruction procedures