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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 -196oC)
  • 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┬ádestruction
  • 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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Explore the PCI Process Phase by Phase

PRE-CLINICAL
PHASE I
PHASE II
PHASE III
COMMERCIAL

Swipe to explore the PCI Process

PRE CLINICAL

pre-clinical-icon
  • Formulation Development
  • Analytical development/characterisation

PHASE 1

PCI 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

PCI 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

PCI 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

PCI Commercial Phase
  • 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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