At the center of every clinical trial is a patient waiting for a treatment to arrive safely and on time. In the highly competitive drug development market, biopharma companies face myriad challenges—from balancing cost, time, and quality to delivering the best possible outcome for their trial and their patients.
Our end-to-end global clinical supply chain services, formerly Fisher Clinical Services, are powered by people with an unwavering dedication to serving clinical research and patients around the world. Whether your investigational medicinal product (IMP) is a traditional small molecule, biologic, or advanced therapy, our more than 30 years of clinical trial services experience can provide support and expertise across your supply chain. We offer services for IMP, comparator, co-medication, and ancillary clinical supplies; including strategy, sourcing, management, packaging and labeling, storage, and distribution.
Download our interactive infographic to explore Patheon's end-to-end clinical trial service capabilities.
With more than 30 years of clinical trial experience and a breadth of services, Patheon can provide support and expertise across your supply chain.
With 35+ years’ experience in ultra cold chain management and logistics solutions we expertly safeguard the integrity of your advanced therapeutics and biological materials from storage to shipment, and everything in between.
Our comprehensive, end-to-end cold chain management solutions can support your advanced clinical trial at every stage, with services including:
We support clinical trials with an integrated supply chain and dependable global sourcing strategies. Complete with full packaging and distribution services, documentation support, and the highest product quality available, we strive to mitigate risk across the supply chain. Our Comparator Center of Excellence in Basel, Switzerland, includes dedicated teams in the United Kingdom, the United States, and strategic locations throughout Asia.
Our blinding and clinical manufacturing cGMP and GAMP 5 (good automated manufacturing practice) services for clinical trials bring a customized approach that includes a comprehensive offering expertly aligned with regulatory and quality guidelines. It is our daily business to handle non-standard and challenging projects, so over the years we have designed and manufactured specific tools and automation to address special processing needs
Sourcing clinical trial ancillary supplies is much more than just procurement. It requires an understanding of the study’s design and requirements, in-depth knowledge of international regulations, and rigorous proactive planning to ensure that the most appropriate equipment and materials are purchased and provided at the right time and at a competitive price. Our clinical ancillary management team has a unique blend of clinical supply expertise and unparalleled access to Thermo Fisher Scientific’s vast array of laboratory and clinical products.
We’re constantly monitoring the global regulatory framework to have a fully compliant supply chain (e.g., U.S. Affordable Care Act / Sunshine Act). Through harmonizing procedures with one global quality system and fully qualifying all suppliers, we secure the supply chain to continually supply the ancillary products you need.
Clinical trial label production requires a higher level of oversight and management than a commercial labeling operation to protect the integrity of blind, as well as meet stringent regulatory controls. Our advanced inspection software, full in-house print capabilities, translation and regulatory approval management process, and centralized web-based document management/routing platform, are specifically designed to reduce overall label cycle times.
A successful clinical trial is dependent on numerous factors, one of which is the effective planning and management of the clinical trial material supply chain. Our clinical supply optimization service is a comprehensive service designed to manage, optimize, and streamline the clinical supply chain from early strategy development through the enrollment, maintenance, and closeout phases of a trial.
Once patient enrollment begins, effective supply chain management must continue to make sure the inventory is in the right locations to enable patient dosing. Other activities such as maintaining the clinical supply forecast, communication with key stakeholders, metrics reporting, planning resupplies, and coordinating dating extensions are all critical to an effectively managed supply chain.
What clinical teams should know about changing trial logistics and how they will affect development
Patheon pharma services fully owned facilities support ambient, refrigerated, and frozen packaging capabilities. These facilities are strategically located around the globe to accommodate regional needs. An integrated IT system links each packaging facility to give clients control of inventory through bar coding standards.
Enabling our customers to make the world healthier, cleaner and safer through enhanced shipment visibility
Global visibility anywhere, anytime
Track all your shipments in one place
View your cold chain shipments using real-time temperature and location tracking
For more than 30 years, we’ve supported the clinical trial supply, distribution, and logistics requirements of pharmaceutical and biotech sponsors worldwide. Our 27 purpose-built GMP/GDP compliant facilities, supported by more than 38 partner depots located across five continents, provide the global presence to support the regulatory-compliant movement, management, and delivery of supplies to more than 150 countries across all therapeutic indications. Our logistics experts handle the storage and distribution of labeled or packaged ambient and cold chain clinical trial materials, investigational medicinal products, comparator medicinal products and placebos, import/export services (including Importer of Record [IOR] capability in more than 24 countries to date), and returns and destruction of supplies across our network.
Total Transportation Management service includes:
Leveraging our network of cGMP sites strategically located across the globe, our logistics expertise and our teams of in-country experts, Thermo Fisher Scientific is in the unique position to handle the entire supply chain from start to finish, including the provision of IOR services in more than 25 countries.
The IOR is a legal entity responsible for:
We recognize the importance of delivering clinical trial materials to the right patient on-time and in-full. Our global logistics help desk provides worldwide support for customers using the clinical trial services facility network. This includes track and trace capabilities incorporating proactive intervention and resolution of all shipment delays, as well as 24/5 telephone and email support for anyone requiring assistance with a shipment.
The help desk global team can provide assistance with:
Contact the help desk by emailing:
GL.HD@thermofisher.com or by calling your country-specific telephone number from this list. Please have the study number and/or packing list available when you call.
The typical clinical trial experiences a 30% patient dropout rate, which directly translates to increased risk and cost. According to patients, the study location and time spent on clinical visits are two of the top three dislikes of their overall clinical trial experience. These concerns can be eased or eliminated with decentralized clinical trials (DCTs).
DCTs have been an option for drug makers since the 1990s, and Patheon pharma services’ direct-to-patient offerings have been there from the start, with support now offered in more than 50 countries. Although DCTs are on the rise, there remain differing levels of comfort and readiness for pursuing DCTs, for not only drug developers but also the clinical sites and patients involved. That’s why we offer services to support traditional clinical trial channels, hybrid trials, and 100% decentralized trials.
In addition to DCT, we offer smart packaging capabilities to further help customers increase patient medication adherence. Smart drug packaging uses microcircuitry to passively measure dosing data and connect to the cloud using technology such as the patient’s smartphone. Cloud-based platforms then use sophisticated algorithms to analyze patient dosing behaviors and flag anything erratic so site staff can “rescue” patients and get them back to their regimen.
Smart packaging for medication adherence provides a rich and reliable data set to help understand patient dosing, making it applicable to most trial designs. It is especially useful for trials that:
How to make decentralized clinical trials a win for patients, sponsors, and investigators
The Global Gateway portal provides real time data transparency anytime and anywhere. It makes accessing inventory and distribution information of clinical trial supplies easy and fast for pharma and biotech companies.