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Clinical Services

Support Services

Rigorous attention to detail is paramount to the successful execution of global clinical trials. We offer the expertise to assist our clients overcome the most complicated of challenges, with a collaborative approach to problem solving.

Engaging our clients 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.

At PCI, our mission is to offer the industry’s leading customer experience. This dedication is championed by our highly motivated and professional project management teams across North America and Europe. Our teams work with clients on all aspects of their projects, leading to successful outcomes and ensuring client satisfaction. Project Managers are involved at the earliest stages of project development, providing insights and experiences to guide projects and optimize critical timelines.

Complimenting developmental project management teams are dedicated Storage and Distribution Project Managers who are versed in best storage and distribution practices and country specific requirements. This experience and dedication ensures that the correct product is delivered to the designated site at the optimal time, each and every time.

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, the global supply chain strategy and global logistics

PCI’s Webflow™ solution is a proprietary and bespoke client access portal which utilizes the latest web-based technologies to provide easy to access, secure and real-time information 24/7 from anywhere in the world.

The system allows users to proactively manage inventory levels, track investigational site shipments and access other related clinical trial information in an instant. Clients also have access to real-time stock levels, pending and outbound order information as well as the ability to track inventory and shipments across our global partnered depot network.

Webflow™ benefits allow convenient and secure access to:

  • Key projects and documents from any location at any time
  • Live stock levels by stock item and status
  • Live sales order information; orders being processed and dispatched orders
  • Blinded or un-blinded sales and stock information
  • Tracking of dispatched orders
  • Real-time inventory management
  • Efficient and effective supply management
  • Proactive control of inventory
  • Visibility of stock levels and status
  • Greater visibility of shipment information
  • Easy access to project related documents
  • Complimentary service
  • ALL available 24/7

The PCIFastTrack™ offering is a demand led approach to the delivery of secondary packaging, labeling, release and distribution of clinical supplies based on patient and site requirements. Designed by applying industry best practices, PCIFastTrack™ 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 business days.

Developed in advance of packaging operations and maintaining rigorous cGMP standards, the PCIFastTrack™ service uses custom operating procedures and workflows created to significantly streamline processes. While 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 efficiently through existing systems with QP engagement at every touchpoint.

Benefits

  • Faster delivery of projects
  • Seamless delivery and industry leading quality
  • Full project status visibility
  • Dedicated and expert team empowered to deliver your projects
  • Dedicated QP support with no compromise on quality
  • Efficient use of clinical drug product

PCI is partnering with industry leader Suvoda to deliver a best-in-class seamless IRT system to our customers. Utilizing innovative technologies, system flexibility and creative design the Suvoda solution ensures exceptional customer service.

Flexibility and Speed

Utilizing proprietary architecture with Modularity, the Suvoda IRT system is engineered for rapid deployment, design flexibility and continuous enhancement. The modular system architecture enables the services team to select modules from a central library, configures them for a specific study and create new modules to meet unique study-specific needs with rapid deployment. These new modules are then assessed, validated and included in iterative releases of the central feature library for re-use in future studies. This is done using a proprietary process that marries the software engineering methodology of “continuous deployment” with the requirements for regulatory compliance, resulting in rapid innovation with assured quality and compliance.

Comprehensive Features

Utilizing state-of-the-art technologies, the Suvoda IRT system delivers a set of comprehensive features for both Drug Supply manager and Study managers. This allows users to set their system in a way that suits their study specific needs.

The Suvoda system also features integration in PCI’s supply network for packaging and labeling services, global storage and distribution, as well as returns management including reconciliation and certified distribution.

Easy Integration

The Suvoda platform has been designed for easy integration with third party systems and has been built to be fully interoperable with other systems through standard application programing interfaces (APIs), ensuring users receive maximum functionality as well as interoperability.

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 assist with final release for the trial.

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. 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.

Our dedicated team of specialists will be happy to discuss our Support Services with you. Contact us on +1 815-484-1528 (US) or +44 1495 713 633 (UK) or email sales@pciservices.com


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