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. Clinical supplies management provides full traceability of drug supply from manufacturing to dispensation and destruction - making it a key factor in study success, as it avoids information gaps and reduces risks such as out of stock or expiration.

Dealing With Stringent Handling Requirement

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 Trial 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 enrollment and significantly reduced site efforts.
  • Qualified and established global depot network
  • Warehouse management system & entire material stock control
  • Standardized return & destruction procedures
SIMPLIFYING END-TO-END GLOBAL CLINICAL LOGISTICS

Brochure

Global experience, integrated solutions, and a multinational infrastructure for seamless clinical trial material management.

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CLINICAL TRIAL MATERIAL STORAGE AND DISTRIBUTION - A CRITICAL MISSION

Article

Download "Clinical Trial Material Storage and Distribution - A Critical Mission" article as published in Journal For Clinical Studies (Volume)

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CLINICAL TRIAL SUPPLIES CAPABILITIES

Fact Sheet

Download our Clinical Trial Supplies Fact Sheet and discover our capabilities.

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PAREXEL SIMPLIFYING THE GLOBAL CLINICAL SUPPLY CHAIN

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Explore the advantages of working with PAREXEL®, who effectively simplify the end-to-end global clinical logistics process.

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PLANNING FOR SURPRISES IN CLINICAL LOGISTICS

Article

Creating and managing a successful clinical supply chain in today’s complex pharmaceutical environment takes holistic planning and an ability to adjust quickly

By Susanne Mueller and Robert Mueller, Clinical Trial Supplies & Logistics, PAREXEL


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PREPARING FOR THE JOURNEY

Article

Download 'Preparing for the Journey' article as published in Pharmaceutical Manufacturing and Packing Sourcer May 2014.
Authored by Mark Cadman and Jens Mattuschka.

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