PPD Functional Service Partnership (FSP) Global Clinical Supplies (GCS) Solutions
Discover the leading end-to-end solution to optimize your global supply chain
As biotech, biopharmaceutical and medical device organizations seek to more effectively manage all aspects of their clinical trial supplies life cycle, efficiently navigating challenging logistical processes and global regulations is critical.
Our PPDTM Functional Service Partnership (FSP) Global Clinical Supplies (GCS) solutions apply unique clinical sites and patient insights and, with the ease of a single partner, optimize all aspects of your clinical trial supplies life cycle. With the flexibility of an FSP model, our extensive breadth and depth of protocol and portfolio-level supply management services deliver proven processes and expertise for nimbly managing entire clinical supply chains. In addition, our global logistics network, advanced systems and flexible models drive the traceability and efficiency you need.
Through our unmatched expertise delivering customizable solutions and an uncompromising commitment to quality, our solutions deliver much needed resource flexibility, reliability and continuity – whether you need an embedded supply chain expert, time and materials consulting, or end-to-end global supply solutions to complement your existing infrastructure.
Our global clinical supplies expertise,
by the numbers
More than 30 years of drug and device development experience
Services delivered for more than 800 studies across more than 270 individual clients
More than 600 staff across 38 countries
Extensive local and central vendor options with physical presence in over 28 countries globally
31 global depot locations
More than 27,000 imports and exports annually
36-hour shipment turnaround time
Extensive experience with top 10 interactive response technology (IRT) providers
29 purpose-built cGMP facilities, and more than 250 packaging rooms strategically located in emerging regions
Our supply pooling and automation expertise helps you:
Reduce costs associated with freight, broker fees and overall customs frequency of operations by up to 75%
Decrease time spent by clinical research associates (CRAs) and site coordinators on administrative tasks to manage clinical supplies by 50-75%
Minimize overage of expensive comparator, equipment and ancillary products to <10%
Extensive breadth and depth of global services, plus the ease of a single partner
Our PPD FSP GCS solutions provide an established track record of global expertise across all stages of the clinical trial supplies life cycle, including forecasting, vendor management and analytics — affording our clients the convenience and ease of working with a single, global partner.
Using embedded quality, regulatory, and trade compliance capabilities, our solutions optimize the global supply chain early during the clinical supply planning and forecasting stage, offering time savings efficiencies for regulatory submission, label development, forecasting, and procurement of goods required.
Our solutions also accelerate the provision of clinical trial supplies and create efficiencies by:
- Synergizing and designing existing and future system integrations to support the convergence of all clinical supplies for Phase I to III studies.
- Offering flexible central and local procurement for thousands of commercial comparators and hundreds of ancillary products and equipment including rentals, buyback and managed calibration schedules.
We specialize in protocol and/or portfolio-level supply management for:
Our integrated GCS services include
- Clinical supply life cycle management: Provides a single point of contact for clinical supply management, from bulk product forecasting through expiry date monitoring and destruction, shipment request and inverse logistics.
- Forecasting: Provides efficiencies for regulatory submission, label development, forecasting and procurement of goods required.
- Global procurement and inventory management: Offers multiple services including product receipt, storage, distribution, relabeling, return, accountability and destruction coordination services.
- Packaging and labeling: Supports all aspects of label development through a label text development solution for text creation and translations, country submission, materials printing and package labeling, including automatic creation and translation of country label text and a validated audit trail.
- Vendor management: Identifies and selects third-party providers with oversight of contracting, finances and performance delivery.
- Device provisioning and management: Implements Internet of Things (IoT) integration into clinical study procurement, configuration, logistics and data.
- Clinical logistics monitoring: Plans, executes and manages specialized logistics/chain of custody associated with unique needs of cell and gene therapy studies.
- Project management: Provides operational leadership, consultancy, project coordination and forecasting for global clinical supplies and IRT.
- Depot services: Supports sites on every continent by providing global distribution through our owned and third-party managed depots or audited and approved vendors.
- Trade compliance: Ensures all materials imported for trials and their shipping documents comply with global and local trade agreements, regulations and language using a sophisticated network of regional trade experts and importer of record (IOR) responsibility.
Proven processes and expertise to nimbly manage entire clinical supply chains
Processes and expertise are essential components of any successful supply chain strategy. Our PPD FSP GCS solutions have a proven track record managing tens of thousands of shipments per year with maximum efficiency due to dedicated experts, extensive standard operating procedures (SOPs) and detailed training to ensure on-site delivery of investigational products and ancillary supplies.
Our teams include project managers that nimbly manage your entire clinical supply chain, from investigational products to all other trial supplies, operational teams of experts in logistics, import/export, and procurement, and quality assurance teams comprised of GMP-qualified persons, quality auditors, and quality associates.
In addition, our extensive team of qualified persons provides expertise in release of different dosage forms, support for auditing facilities, hosting regulatory inspections (EU & FDA), supply chain quality assurance and quality assurance for complex biologics / ATMP batch review.
We continuously adapt to new requirements, technologies, pandemics, rapidly evolving patient needs and new types of drugs in development, as evidenced in our expertise across all clinical supply chain markets, including:
- Direct-to-patient (and direct-from-patient)
- Digital
- Cell and gene therapy / advanced therapy medicinal products (ATMPs)
- Biotech and biopharma
- Vaccines
Our global logistics network, advanced systems and flexible models drive quality, traceability and efficiency
Through the combination of Thermo Fisher Scientific’s global logistics network and infrastructure with our advanced systems, process maps, and SOPs, our PPD GCS FSP solutions provide streamlined workflows to enhance global quality, traceability and efficiency. Our solutions leverage well-established partnerships with third-party vendors that have passed rigorous vendor qualification processes, are fully integrated into our supply chain network, and are managed and monitored through routine audits.
Our experience running program-level pooling across global studies also minimizes overages of expensive comparators, equipment and ancillary product, and we engage local import/export experts to standardize pro forma invoices and preclear shipments, where possible, to reduce distribution time per shipment and enable central sourcing consistency across study sites. Consolidation of investigational products, lab and other supplies needed for a study also significantly reduces costs.
Our solutions also facilitate rapid and flexible deployment of personalized partnership models including custom rates, qualification and implementation via quality technical agreements (QTAs) and master service agreements (MSAs). From the outset, we partner with you to personalize the outsourcing model specifically for your needs, including a flexible mix of systems, processes, oversight and facilities – yours or ours. We can work by embedding our staff within your workforce, by using client systems and processes, or by taking the work fully in-house and using our innovations and technologies. We also utilize innovative pricing models to accommodate various contract structures from full-time equivalent (FTE), unit-based, outputs-based, time & materials and hybrid models.
Contact us
Ready to more efficiently navigate challenging logistical processes and global regulations? Connect with our PPD FSP Global Clinical Supplies solutions team to learn more about how we optimize all aspects of your clinical trial supplies life cycle.