Alabama Finance

Nov 21 2017

Clinical Supplies Management #clinical #trial #supply #management


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Clinical Supplies Management

Whether you require a tailor made service to facilitate transition of your Investigational New Drug (IND) from development to clinical trial site, a storage solution for your supplies or packing, storage and distribution of commercial supplies, PCI offers a comprehensive service delivering cost-effective solutions for our clients.

Our Clinical Supplies Service consists of:

  • QP certification and consultancy services
  • Clinical Supplies Project Management
  • Blinding and over-encapsulation
  • Bespoke clinical packaging design
  • Label design and printing
  • Patient kit labeling and assembly
  • Comparator sourcing
  • Storage over a wide range of temperatures (controlled ambient to -196 o C)
  • Global general, Cold Chain and Ultra-Cold Chain logistics and distribution
  • Supply chain management of ambient, refrigerated and frozen shipments
  • Returns management including; return supplies, reconciliation, storage and destruction
  • Sample collection, reconciliation, storage and shipment to testing laboratories

Talk to us about a potential project and we will assign a skilled, dedicated and experienced Project Manager who will work with you to design a clinical supplies management strategy using our unique product supply route map . They will agree goals, budgets and timeframes, and remain with you to take your project through to successful completion.

With PCI Pharma Services Clinical Supplies Management, you will always have:

  • One point of contact for project duration
  • A Technical Agreement including roles and responsibilities
  • A full project plan
  • Full documentation at each stage
  • On-line access to your PCI Pharma Services operational account through our unique Webflow service

Partnering with PCI Pharma Services ensures adding value through:

  • Improving speed-to-market
  • Facilitating a quick and smooth import into the European Union
  • Effective relationships between PCI and client Project Managers
  • Protocols interpretation and conversion of finished supplies
  • Optimal patient kit design
  • Delivery of supplies to patients on time

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PHASE 1

  • Formulation Development
  • Analytical Development
  • Drug in capsule/vial technology (Xcelodose)®
  • Phase I product manufacture
  • Tablets/Capsules
  • Blinding via over-encapsulation
  • Phase I packaging and labelling
  • Storage and distribution

PHASE 2

  • Formulation Optimization
  • Dosage Form Process Validation
  • Analytical Testing and Stability Services
  • Phase II Product Manufacture
  • Tablets/Capsules
  • Blinding via over-encapsulation
  • Phase II packaging and labelling
  • Storage and distribution

PHASE 3

  • Comparator Sourcing
  • Scale Up Studies
  • Phase III Product Manufacture
  • Tablets/Capsules
  • Blinding via over-encapsulation
  • Phase III packaging and labelling
  • Analytical testing and stability services
  • Storage and distribution

COMMERCIAL

  • Scale up for commercial supply
  • Commercial product manufacture
  • Commercial packaging and labelling
  • Validation services
  • Analytical testing and stability services
  • Product release to market
  • Storage and distribution


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