Organization of Clinical Operations Units

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Organization of Clinical Operations Units
Steven A. Jacobs, MBA, R.Ph. JJ PRD, LLC.
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Operations Aspects for Clinical Supplies

• Planning
• Supply Chain
• Manufacturing
• Packaging Labeling Operations
• Technical Support
• Customer Relations Management
• Outsourcing
• Sampling Testing

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Planning

• Planning and scheduling
• Timeline integration and adjustment
• Coordination with all partner departments
  (Analytical Development, Pharmaceutical
  Development, Quality Assurance, Outsourcing)

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Supply Chain

• Purchasing
• Receiving and sampling
• Retains
• Storage and inventory management
• Shipping, movement and staging
• Spec review and storage
• Historical data and metrics

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Manufacturing

• Drug substance excipient planning and ordering
• Weighing, mixing, blending, filling, compression,
  coating, and testing
• Batch documentation
• QA release
• Movement to packaging

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Packaging Labeling Operations

• Filling
• Blistering
• Bottling
• Packing and assembly
• Labeling (panel and booklets)
• Sequencing
• Staging to distribution

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Sampling Testing

• Sampling of components and drug product
• Sampling of in process materials during automated
  packaging
• Component testing to match CofA or CofC
• ID testing of packaged goods

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Technical Support

• Technical and process expertise
• Members lead or assist project teams in
  manufacturing
• Troubleshooting on manufacturing or stability
  issues

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Customer Relations Management

• Project Management
• Coordination of all clinical studies
• Liaison between functional groups to ensure on
  time delivery of supplies
• Coordination of randomization and IVRS

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Outsourcing

• Create individual project agreements and ensuring
  Secrecy/CDA agreements are in place
• Coordination with contract vendors
• Ensure contractor timelines are met
• Collate batch documents and arrange for clinical
  supplies release with QA
• Establish metrics to track contractor performance

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Sample Organization 1
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Sample Organization 2
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Sample Organization 3
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Virtual Clinical Supplies Unit