CLINICAL
TRIAL SUPPLYSOLUTIONS• API• BIOLOGICS

SMALL
MOLECULE DRUG
SUBSTANCECAPABILITIES• VIRAL VECTORLARGE
MOLECULE DRUG
SUBSTANCECAPABILITIESSERVICESEARLYDEVELOPMENTCAPABILITIES• EARLY & LATE PHASE
DEVELOPMENT

CLINICAL TRIAL
SOLUTIONS• CLINICAL TRIAL
SOLUTIONSTRANSPORTATIONMANAGEMENTSERVICESCOMMERCIAL
MANUFACTURING• LOGISTICSSERVICESOTC AND SOFTGELTECHNOLOGIES• COMMERCIAL

MANUFACTURING

GLOBAL SITE
NETWORK1

Holli Carlson
Client Services Director,Pharma Services
Mt. Prospect, IL

The drug development landscape has changed.
Our commitment to best-in-class clinical trial
solutions has not.
Nowhere is this more evident than in clinical supply management. Companies are recognizing
the strategic importance of clinical supplies in ensuring drug development risks and costs arewell understood and anticipated for in advance. Upfront planning has become a criticalcomponent to executing a streamlined, efficient and nimble clinical supply chain. As such,clinical supply professionals are playing a more active role in development and study planning,
managing mission critical activities, forecasting and mitigating operational risk.
For over 30 years the Thermo Fisher Scientific team has been committed to helping sponsorsof all sizes develop comprehensive clinical supply plans that incorporate the need for flexibility
in trial execution with a balanced risk and cost approach. From complete clinical supply
plans, to comparator sourcing strategies, distribution strategies and packaging design
recommendations, our experts are on hand to meet any of your strategic planning requirements.

3Robust Fisher Clinical
ServicesSM supply chain
solutions to meet yourclinical trial needs.

PACKAGING DESIGN & PRODUCTION
Keeping the patient in mind is key to identifying the mostoptimal packaging configuration for your trial. Our team ofproject managers in combination with our packaging
engineers can assist you in identifying the most suitable
packaging for your clinical trial in order to ensure patient
safety and compliance.
Services include: Primary, Secondary, Overencapsulation,
Pre-filled syringe, Tamper-evident, Blinding, Climate-controlled(including Cold Rooms)

LABEL SERVICES
Whether needing to implement an Approved Phrase Library(which has been shown to shorten label cycle times by morethan 50 percent) or determining the appropriate label type,text and strategies for your trial, our experienced anddedicated label project management teams can help you
build the strategy that will deliver results both long andshort term.
Services include: Booklet, Single & Multi Panel, Digital,
Alternative Translation & Label Approval System (ATLASSM)

BIOSERVICES
Ensuring a seamless workflow which connects the sponsor,
bio-manufacturer, clinical center, and patient into a wellcoordinated chain of custody is our specialty. As the leaderin managing critical biological material, we provide ourcustomers with customized solutions to store, package,and transport their valuable material.
Services include: Biobanking & Biorepository, Laboratory
Processing, Qualification / Validation, Kit Production, Cold
Chain Logistics

GLOBAL DISTRIBUTION

CLINICAL SUPPLY OPTIMIZATION

Given the ever-expanding global nature of today’s clinical
trials, sponsors demand and deserve the assurance that
their needs will be met regardless of location, and inaccordance with a consistent global quality standard. Our
20 purpose-built GMP/GDP compliant facilities, supportedby over 30 partner depots—located across five continents—
provide the global presence, information systems andquality standards to provide clients the flexibility, accessand assurance needed for their clinical trial.

Leveraging the expertise of a dedicated supply chain team,proprietary technology tools and an extensive cGMP
network, we provide proactive guidance in the developmentof supply strategies, as well as overarching simulation,
forecasting and cost management. This team of professionals
can assist you in identifying themost optimal packaging
configuration, establishing & verifying IRT setup, forecasting
patient clinical supply requirements by country andidentifying the regulatory hurdles you will face based upon
your current country selection.

Services include: Ambient, Refrigerated & Cold Storage,
Controlled Substance Storage, GDP Distribution Services
to over 150 countries

Services include: Forecasting, End-to-End Supply Chain
Management, Centralized Project Management, Consolidated
Reporting

TOTAL TRANSPORTATION MANAGEMENTManaging the transportation of life science shipments has
become increasingly complex over the years, with patient
pools expanding, often to remote locations across theglobe. In addition, the growth of biologics creates additional
supply chain challenges due to cold chain handling, storage
and distribution requirements.
Our logistics specialists and teams of in-country experts
can simplify the complexity associated with transportation
planning and monitoring and, as a result, optimize transportation performance and costs across the supply chain.
Services include: Supplier Qualification, Mode Optimization,
Courier Selection & Management, Customs & Regulatory
Guidance, Importer of Record, Cold Chain Supplies Management, Dispatch Services, Proactive Track & Trace, DataObjective Monitoring & Reporting, and Consolidated Billing

COMMERCIAL DRUG SOURCING

CLINICAL ANCILLARY MANAGEMENT
It’s easy to forget about ancillaries when immersed in thedetails of a global clinical supply chain. Our dedicated teamof clinical ancillary project managers can help you develop
a complete ancillary strategy that will ensure your sites areappropriated stocked at time of First Patient In and inaccordance with regulatory requirements.
Services include: Sourcing, Inventory Management, Distribution, Ancillary Returns Management

QP SERVICES
For strategic planning purposes, our team of QP’s areavailable to provide advice on your expiry strategy, including
the most current conditions required by regulatory authorities.
Services include: Regulatory Oversight, Compliance
Guidance

Sourcing comparator, rescue medication, or comedication
for clinical trials is not merely a purchasing or procurement
exercise. Applying a strategic approach, evaluating every
sourcing factor and creating a customized plan with multiple
options results in an optimal comparator sourcing strategy.
Services include: Comparator, Comedication, Rescue
medication sourcing

5Chris, Lauryn,
Carson Rose& AJ Tubesing

MADEFORHOPE & FAMILY

HOW A FAMILY’S PERSEVERANCE HELPED THEM REACH
A SEEMINGLY UNATTAINABLE GOAL.
As members of the United States Air Force, Lauryn and Chris were as healthy andfit as a young couple could be. But when two of their three children tested positive
for Cystic Fibrosis, everything changed. Along with endless treatments, trips to thedoctor, and fear of catching even the slightest cold, was the realization that a typicallife expectancy was of only about 31. They soon learned of a “wonder drug” that washelping CF patients in trials, and actually treated the disease, not just the symptoms.
When they were finally approved, it took only 6 months for their doctor to say something
they hadn’t heard before: “Your daughter looks healthy.” Now, with a life expectancy
into the 60s and beyond, these two veterans are free to have all the dreams parents
have for their kids.

+1 610-391-0800• pharmaservices@thermofisher.com • www.fisherclinicalservices.com© 2020 Thermo Fisher Scientific Inc. All rights reserved.
Published 2/20 PSG0757