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 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.
With more than 30 years of clinical trial experience and a breadth of services, we can provide support and expertise across your supply chain.
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
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.
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.
Our standard blinding services through clinical manufacturing include:
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.
Patheon pharma services fully owned facilities supporting ambient and refrigerated packaging and are strategically situated around the globe to accommodate local or regional sourcing needs. An integrated IT system links each packaging facility to give clients control of inventory through bar coding standards.
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.
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
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
With our global network of biorepositories and experience gained through maintaining the integrity of millions of samples, we can transport, store, and process specialized biological material from ambient to cryogenic temperatures. Each biorepository site can be configured and replicated to meet the specific requirements of individual clinical trials with minimal variation, regardless of volume or geographic location. This is supported by a global comprehensive and integrated quality system based on regulatory requirements, industry best practices, and highly trained personnel.
Consistent quality. Global network. Dedicated to you.
Whether you are preparing vaccines or personalized gene therapies, or safeguarding cell lines for future discoveries, we are committed to protecting your irreplaceable biological materials.
We have the industry’s largest network of fully owned cGMP facilities strategically located around the world to store and move your inventory of biosamples, cell lines, or single-dose cell therapy. Whether the requirement is single use, high performance reusable systems, small parcel, bulk single, or multi-pallet shipments, we have an extensive range of qualified solutions to meet customer needs.
Continuous monitoring solutions for enhanced visibility of your cryogenic shipments:
We also have a team of specialty logistics experts using a global network of qualified carriers to provide best quality service:
Labeling at ultracold temperatures adds significant complexity—our team will work with you to develop a primary and secondary labeling strategy to account for temperature requirements, variable dosing, blinding requirements, or patient specific information. We also have experience with commercial packaging.
On average, 13% of samples are contaminated during collection. Kits can be used to mitigate this risk and standardize the collection process, which is a major factor in controlling pre-analytical variability. Our collection and administration kits help standardize every aspect of sample handling, from collection through administration or analysis by providing everything technicians need to collect and retrieve a specimen or administer treatment for investigational use in clinical trials.
Using state-of-the-art workflows, advanced genomics approaches, and comprehensive informatics solutions, we provide timely and accurate analysis of stored samples in our BSL-2 and CL3 laboratories.
Sample processing capabilities include:
Automated nucleic acid or protein extractions and analysis: