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FastTrackTM

‏Traditionally the end to end clinical trials packaging process touches a number of different departments and people with the industry standard for the turnaround of such projects traditionally taking between 6-12 weeks…

FastTrack

Now more than ever, time is of the essence when delivering global clinical trials. Complicated study protocols, demanding deadlines, and distribution to remote global destinations create challenges for timely execution.

PCI’s FastTrackTM offering is a demand led approach to the delivery of secondary packaging, labelling, release and distribution of clinical supplies based on patient and site requirements. Designed by applying industry best practices, FastTrackTM will deliver compliant clinical trial supplies, for time-critical studies, in the shortest possible time, without compromising on quality. Depending on the availability of materials these projects can be turned around in less than 10 days.

Developed in advance of packaging and operations and maintaining rigorous cGMP standards, the FastTrack™ service uses individual operating procedures and workflows which have been created to significantly streamline all processes. Whilst it is common for businesses to use routine staff in similar service offerings PCI ensures the deployment of a team of highly-skilled, dedicated and crossed trained personnel to conduct multiple tasks which work through existing systems efficiently and with QP’s at every touchpoint.

Benefits

  • Faster delivery of projects
  • Smooth delivery and quality
  • Project status visibility
  • Dedicated and expert team empowered to deliver
  • your projects
  • Dedicated QP support
  • Efficient use of clinical drug product
  • Reduction in waste
  • Reduced risk to supply

Using FastTrackTM we can offer:

FASTTRACK

Full study set up, packaging and release within 10 working days

FASTTRACK ON DEMAND

Re-supply packaging run of material within 3 working days

FASTTRACK JUST IN TIME

Application of a protocol label to the outer of a semifinished kit at the point of dispatch within 2 days

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

PCI Points...

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Our global reach and localized support ensures PCI as a strategic partner remains focussed on delivering speed-to-market and the commercial success of our customers

PCI is a global company that focusses on delivering speed-to-market and the commercial success of our customers

Why choose us...