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Clinical Trial Support Services

Rigorous attention to detail is paramount to successful execution of global clinical trials.

We offer the expertise to help our clients overcome the most complicated of challenges, with a collaborative approach to problem solving.

Engaging our customers at the earliest stages of clinical protocol development enables our team to provide insights into optimizing trial costs and efficiency, critical to expediting clinical trial execution.
From the onset, our team is working to provide the necessary analysis and insight, including protocol interpretation,

sourcing of comparator product, detailed analysis of the plan for regional and global distribution, interfacing with Interactive Response Technologies (IRT), language translation and multi-language labeling, and full support for randomization and blinding.

 

Efficient and effective clinical trials start with a clear understanding of the trial requirements. PCI’s project management team brings significant expertise to this vital part of the process, calling on many years of experience when helping clients in designing the most effective packaging solution to support the trial and global supply chain strategy and global logistics.
Through our network of specialist suppliers, PCI is able to source comparator products throughout the world. All comparator supplies are accompanied with the necessary documentation to provide a full pedigree and to assist with final release for the trial.

Our in-house analytical and over-encapsulation services ensure that we are able to offer a comprehensive sourcing and packaging service for all types of comparator products in a timely fashion.

At PCI, we understand the importance of a well detailed, global logistics strategy. We partner with the client and the IVRS supplier to determine the necessary supply strategy overage needed to support recruitment in the selected countries, offering a comprehensive global distribution plan through our in-house distribution facilities and our strategic supply network. We offer flexibility, including specialized services that support a logistics strategy including just-in-time labeling or point-of-dispatch customization.
PCI provides a comprehensive translation service through our network of approved suppliers. We provide efficient translation and guarantee accuracy. All translations are accompanied with a certificate of compliance with their country specific regulatory requirements.
At PCI, we offer extensive experience in providing translations and in-labeling supplies for global trials. During the development of the packaging and distribution strategies, we model the most efficient use of supplies to ensure rapid availability of supplies to sites, while minimizing potential overage. We offer packaging solutions based on client preference and trial requirements, including packaging for individual countries, combined regions, pooled supplies or generalized global formats. PCI offers a highly professional and experienced label design service for both single panel (multi-language) labels and multi-language booklet labels. This includes label solutions for cold chain refrigerated and frozen supplies.
Our label design and printing systems feature solutions for offering highly complex randomizations. Our flexible systems can accommodate importing pre-prepared randomizations, or work with our clients to develop the randomizations as part of their trial planning and development. We can work with any block size and randomization design, including building any required stratifications.
Across our global network, we utilize best-in-class Enterprise Resource Planning (ERP) systems for each step of the clinical supply process, with seamless support across continents. In-keeping with our commitment to unparaleled client support, around-the-clock data access is enabled through our secure client portal, Webflow; allowing real-time management of supplies and reporting. Customer access and supplies reporting is customizable, enabling customers to personalize to the needs of their specific trial. Live reporting provides customers insight into their global supply chain and instant access to make critical supply decisions.

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...