Clinical Supply Management

Experienced Professionals and Advanced Modeling Capabilities for even the most complex trials

Clinical Supplies Management (CSM) brings the experience of our drug supply professionals to a client’s study, providing expertise throughout the complete clinical supply project lifecycle - from initial packaging strategy to final drug accountability.

Supported by forecasting and simulation capabilities, we can optimize study design and ensure cost-effective approaches for on-going clinical supply management for either single protocols or entire programs.

Catalent Benefits:

• Single point of contact coordinating the necessary information between clinical functions
• Ensures that clinical drugs and supplies are available in appropriate quantities where they are needed and when they are needed
• Supports cost saving through reducing drug wastage:
  • unnecessary drug campaigns
  • more efficient shipping and inventory practices
  • optimized comparator procurement
  • minimizes the risk of a subject not having drug available at their drug assignment visit.

Catalent Capabilities:

• Creation of overall packaging and distribution plan/strategy
• Drug projections and enrollment projections
• Determine subject drug visit requirements
• Supports comparator procurement strategies
• Re-forecast ongoing supply requirements as study progresses
• Request manual drug orders
• Manage/monitor site/system drug orders and site drug shipments
• Manage/monitor site inventory levels
• Manage/monitor ancillary and comparator supplies inventory
• Support for IRT design/approval (URS/UAT)
• Assist in distribution pack out design
• Assist in coordination of temperature monitor processing
• Assist with creating shipment excursion release process
• Provide final drug accountability reports to Clinical
• Coordinate drug return and accountability process
• Coordinate destruction of reconciled study drug

Facilities:

With uniform systems and facilities in the US, UK, Germany and Singapore - and an extended network of over 60 audited depots - our capacity enables us to adapt to and handle all your international compliance and distribution needs, ultimately reducing your turnaround time.

• Philadelphia, Pennsylvania, USA
• Kansas City, Missouri, USA
• Bolton, England
• Deeside, Wales
• Schorndorf, Germany
• Shanghai, China
• Singapore