Clinical trial services

Global clinical supply solutions for every trial

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.


Our solutions offer the depth, breadth, and flexibility you need.

With more than 30 years of clinical trial experience and a breadth of services, we can provide support and expertise across your supply chain.

Label design and translation management services 

Comparator and co-medication sourcing and management

Storage, distribution, and logistics management

Clinical ancillary supplies sourcing and management

Clinical supply optimization and supply chain management

Primary and secondary packaging

Decentralized trials specialty services

Advanced therapeutics specialty services

Clinical trial services, solutions, and capabilities

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.

  • Proactive guidance in the development of supply strategy
  • Clinical supply forecasts that are robust and developed with access to sophisticated Monte Carlo simulation technology
  • Ongoing maintenance of those forecasts that reflect actual data as the trial continues
  • Proactive supply chain management ensures clinical supplies are available when needed
  • Minimized supply chain risk, waste, and complexity
  • Budgetary reporting and dashboards
  • Management of an individual study, portfolio of studies, and investigator-initiated trials (IITs) at any stage of development
  • Returns and reconciliation of supplies at the end of a study to ensure protocol requirements are met and the trial is closed compliantly

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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.

  • Laboratory equipment and supplies
  • Medical/diagnostic equipment and supplies
  • Drug delivery equipment and supplies
  • General clinical supplies
  • Educational materials
  • Other items as needed for your trial design

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.

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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.

 

Comparator sourcing services highlights
  • Sourcing strategy consulting and full-service procurement of drugs
  • Regulatory expertise and market intelligence—trade and tax compliance with robust supplier qualification process and anticounterfeit procedures
  • Sourcing for any comparator drug or IMP, reference medicinal products, matching placebo, rescue, background, co-medication, and standard of care
  • Capability to source everything from one sample to large quantities for multi-year phase III trials either directly from the innovator, local, or open market sourcing
  • Integrated services including clinical supply optimization, labeling, packaging, and distribution
 
Blinding and microdosing

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:

  • Blinding of pre-filled syringes, vials, bottles, nasal spray, and IV bags
  • De-blistering, de-bottling, de-inking, and tablet breaking of globally sourced comparator drugs
  • Fully automated blinding through single and multi-product over-encapsulation
  • High speed manufacturing of matching placebo and inhalation capsules
  • Microdosing of API and API blends and blending of excipients
  • Special projects with hazardous components
  • Analytical testing of blinded comparator

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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:

  • Supplier qualification to review suppliers against stringent quality and performance standards
  • Mode optimization (courier selection and management) to recommend the best transportation approach for your goals
  • Customs and regulatory guidance and facilitation mitigates risk of costly delays
  • Cold chain supplies management and an environmentally friendly reusable shipper program
  • Dispatch services coordinate all aspects of scheduling and documentation
  • Proactive track and trace including 24/5 telephone and email support
  • Data objective monitoring and reporting of all shipments enables fact-based decision-making
  • Consolidated billing decreases the administrative burden of managing supplier-specific invoices
 
Importer of Record (IOR)

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:

  • Ensuring the imported goods comply with local laws
  • Filing a completed duty entry and associated documents
  • Paying the assessed import duties and other taxes on those goods
  • Thermo Fisher Scientific is fully vetted and compliant in regional and country specific laws providing IOR services across the globe
 
Global logistics help desk

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:

  • Shipment tracking queries
  • Damaged or incorrect shipments
  • Customs clearance issues
  • Late or lost shipments
  • Temperature excursion reporting

 

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.

Helpful resources 

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.

 

Primary packaging
  • Coldform/Thermoform blistering lines in temperature and humidity monitored rooms
  • In-house tooling creation, on-line printing, and in-process vision control systems
  • Single and multi-pack capabilities
  • Automation that reduces cycle times and containment suites that handle potent or powder compounds with independent engineering resources
 
Secondary packaging and labeling
  • Range of package types including child-resistant blister cards and bottles, vials, patches, syringes, inhalers, and other devices
  • Manual or automated pack and assembly in rooms with managed temperature requirements
  • Label design, translations, and blinding for single-panel and multi-panel, as well as 1-3 panel booklet labels and digital labels

 

ProSyriesSM pre-filled syringe assembly and labeling
  • Precision-controlled syringe that’s assembled and labeled using a fully automated, temperature controlled, continuous process
  • Automated production lines available in both ambient and cold environments
  • OCR-OCV controls and built-in quality processes ensure 100% inspection of variable and fixed test for accuracy and legibility
  • ProSyries Syringe Tray, designed prevent stopper/plunger movement during air transit
  • ProSyries High Precision Syringe Labeling is available for any fill level of pre-filled syringes with +/-0.5MM accuracy
 
 
Tour the Thermo Fisher Scientific Center of Excellence for prefilled syringe assembly, primary and secondary packaging, clinical trial labeling, blinding of clinical materials, and cold chain distribution.

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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.

 

Label services highlights
  • Guidance on label setup, coordination of translations, regulatory review, and randomizations
  • Full design capabilities (you only need to provide English text)
  • Label design and manufacture integrated with regulatory, packaging, and clinical logistics
  • Individual batch record control and release on a job-by-job basis
  • Single- and two-panel labels, GlobalPly multilingual booklet labels, DigiPly digital booklet labels
  • ATLASSM translations management system

 

GlobalPlySM MultiLingual Booklet Label Services
  • GlobalPly multilingual booklet labels can be manufactured to almost any size, on a variety of face-stock material and base label adhesives
  • Recommended for international studies requiring fixed text and variable text printing

 

DigiPlySM Digital Booklet Label Services
  • DigiPly is the first digitally produced label in the industry
  • Allows for addition/removal of countries in days, rather than weeks—once digitally laid out and approved, new countries can be added without having to lay out a new label design
  • DigiPly labels are constructed using a synthetic biaxially oriented polypropylene (BOPP) that will not rip upon application or use, ensuring data integrity throughout the clinical trial
  • With up to 60 pages available for more than 100 languages, you have more room to add critical text, larger text sizes, and color
  • Clinical label-specific, validated translation and approval management web-based system for online label order, text translation, and approval through label manufacturing
  • Reduces clinical label manufacturing timelines by more than 50%
  • Ability to store and auto-populate country specific regulatory requirements
  • Monitoring and management of task translations to foreign affiliates for approval
  • Non-compliant user escalation process and detailed performance metrics tracking
  • Standard phrase library with country specific regulatory information eliminates the need to repeat translations work

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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.

  • Compliant with applicable data privacy laws and regulations
  • Global direct-to-patient service in more than 50 countries and the industry leading global network to support your studies in the rest of the world
  • Nationwide shipments in the United States in all 50 states for IMP and non-IMP drugs
  • Scheduled drug shipments and clinical ancillaries to the patient’s home
  • Shipment coordination with patient, clinical site, and home healthcare nurse (if applicable)
  • Solutions for IRT and non-IRT driven studies
  • Established expertise with setting up decentralized clinical trials and patient compliance support
  • Integrated CRO, IRT provider, clinical supply, and clinical operations teams that cuts your study start-up times to just a few months

 

Smart packaging (adherence measurement solutions)

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:

  • Require a precise understanding of time between doses 
  • Have complex dosing regimens
  • Last longer than 1 year
  • Include long inter-visit periods to clinical sites (decentralized clinical trials)

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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
  • Stay informed every step of the way
  • View your cold chain shipments using real-time temperature and location tracking
  • Track delays and excursions
  • Advanced monitoring for critical cold chain and high value product shipments
Track and Trace digital portal

Track all your shipments in one place 

Real time sensors

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.

 

Biologics management and storage

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.

  • Purpose-built facilities, liquid nitrogen-equipped vehicles, and a global network of logistics experts to transport, store, and protect your materials in ambient to cryogenic conditions
  • Inventory management system allows customers 24/7 access to their data and inventory
  • Storage units with redundant compressors to prevent temperature excursions and a 24/7 monitoring system that notifies personnel of temperature deviations
  • Comprehensive security and material tracking systems including intrusion detection alerts and facilities, freezers, and other cold storage units gated with access-only card readers
  • Every facility equipped with both uninterruptible power supply (UPS) systems and one or more back-up generators
  • Laboratory processing capabilities

 

Cold chain logistics and distribution

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.

  • Controlled temperature pack-outs (-70°C, -20°C, 2-8°C or 15-25°C) by IATA- and HAZMAT-trained personnel to minimize time out of environment
  • Strict adherence to the requirements of Good Distribution Practice (EudraLex Annex 15, EU GDP guideline, 21CFR211.142 and 21CFR211.150)
  • Wholly owned fleet of qualified active and passive shipping systems for any temperature or climate condition, including communal or dedicated dry vapor shippers for cryogenic shipments
  • QP Release for UK and EU shipments
  • Just-in-time packaging, labeling, and distribution services
  • Equipment and measuring devices are calibrated according to NIST standards, and undergo pack out qualification testing
  • Environmentally friendly shipper return and reuse program for Europe, US, and China

 

Continuous monitoring solutions for enhanced visibility of your cryogenic shipments:

  • 24/7 tracking and monitoring of GPS, payload temperature, dewar orientation, and other critical parameters through our specialty courier service
  • Controlled web portal with mobile access provides real-time visibility and temperature data for clinical site use
  • Just-in-time deployment of mission-ready shippers with 21 CFR Part 11 compliant temperature reports and validated data loggers

 

We also have a team of specialty logistics experts using a global network of qualified carriers to provide best quality service:

  • Mode optimization
  • Cold-chain supplies and commercial lane validation
  • Custom and regulatory guidance
  • Dispatch services

 

Secondary packaging and labeling

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.

  • Serialization equipment and software compliant with the Drug Supply Chain and Security Act (DSCSA) requirements and the Falsified Medicines Directive (FMD)
  • All packaging and labeling conducted at temperature
  • Customized just-in-time packaging and labeling workflows based on your processes for time sensitive drug dispatch
  • Translations and regulatory guidance
  • Label and component printing and validation

 

Collection and administration kits

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.

Laboratory processing

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:

  • Multiple sample types including blood and blood derivatives (serum, plasma, RBCs, PBMCs, buffy coat, or blood clots), stool, urine, saliva, CSF, and other body fluids, cancer tissues/cell lines, cfDNA, FFPE blocks, amniotic fluid, cord blood, placenta, breast milk, meconium, nail clippings, hair, semen, cervical swabs, bacteria, plant, food, soil, viruses, or any other human or veterinary samples
  • PBMC extractions, cryo-preservation, and viability testing
  • Automated sample processing, aliquoting, vial capping/decapping, and labeling
  • Automated blood fractionation (buffy coat extraction)

 

Automated nucleic acid or protein extractions and analysis:

  • From variety of samples to get cfDNA, gDNA, RNA, miRNA, or proteins
  • Sizing, quantitation, and purity assessments for DNA, RNA, and protein samples
  • Aliquoting in custom formats with QC testing for high-throughput PCR, qPCR, Sanger sequencing, Microarray, or NGS assays
  • iWestern workflows, ELISA, QuantiGene Plex assay

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