CLINICAL
TRIAL
PACKAGING
SOLUTIONSBALANCING COST,
TIME AND QUALITY

Introduction

3Managing cost4

Controlling timelines

5

Ensuring quality

6

Delivering experience62

Introduction
In today’s highly competitive market for newdrug development, sponsors are challenged withbalancing cost, time and quality to deliver the best
possible outcome for their trial, and more importantly
for their patients.
Cost overruns can be critical—especially for emerging companies who aretasked with raising funds to cover development costs. For large pharma,
where an outsourcing strategy allows them to focus on core strengths,
managing their budget is equally important.
Timing is everything. Accelerating the product approval process translates toa faster income stream that offsets the sponsor’s development investment.
As trials evolve and progress through phases, change is inevitable. Clinical
trial packaging is often impacted by changes to the protocol such as
dosage changes, increases or decreases in volumes, changes to expiry
dates, inclusion/exclusion of countries that weren’t part of the original plan.
Accurately identifying and predicting issues that might impact schedules,
while remaining nimble to adjust to changes is imperative.
Most importantly, quality can never be sacrificed. It’s important to recognizethat quality has a cost and time impact on the study. Through diligent upfront
planning we integrate quality assurance into every facet of the packaging
design plan, proactively anticipating risks and identifying an action plan thatmitigates that risk.
The Fisher Clinical Services team leverages 30+ years of clinical trial
packaging design experience when working with study sponsors. We
understand the importance of taking the time required to establish a detailed
understanding of your needs. Throughout the thoughtful collaboration
process, we serve as a trusted advisor to help you strike the best balance ofcost, time and quality.

3Managing cost
No one likes surprises. Establishing a project planand supporting budget that stays on track throughout
the study is vital. Yes, it may seem overwhelming forthe first-time trial sponsor, but it is a fully transparent
process intended to alleviate the unexpected.

To establish a firm plan that you can rely on requires establishing requirements
at a great level of detail. For example:•

What components will be required in support of packaging the drugproduct? (e.g. film, foil, closures, plastic trays)•Who will source those materials—the sponsor or the vendor? At whatcost, and with what kind of lead time?

•Is there special tooling required and if so, at what cost and lead time?

•

What kind of overage is required to ensure processes can be executed at
the required quality standard?

•What assumptions have been made with respect to storage volume,
freight volume and distribution patterns by destination?

•How will the project be managed? Is there an hourly fee that might
become unmanageable if the scope of project is constantly changing? Oris it a fixed, predictable cost?

As we work with a trial sponsor to understand scope, we apply our experience
to identify any opportunity to gain efficiency. We understand that managing
costs includes adding value, and introducing cost-efficiencies. Instead of you
worrying about all the details, our Project Managers and their support teams
are continually asking questions:•Is there a way we might benefit from automation?

•Can we remove non-essentials?

•Could we create a scalable solution to support multiple trial phases and/orcountries while minimizing waste?

As a full-service clinical packaging provider, we have the added value ofleveraging the skills of Clinical Supply Chain Managers specifically focused on
optimizing the end-to-end supply chain. For example, where should packaging
activities take place to most effectively support a global trial? With theirexpertise we can identify if there might be advantages to an alternate approach
that, over the long run, might prove more efficient.

4Controlling timelines
We have all heard the saying “measure twice,cut once.” It should come as no surprise that
establishing the design and overall plan for a
packaging project consumes a significant amountof time. By investing in a detailed planning process,we can identify areas where our experience will
reveal opportunities to streamline.
It is equally important that we identify any process that may be outsideof our control, and that we plan accordingly. Once again, clinical trial
sponsors don’t need surprises. Critical steps that must be accounted
for include:••

Qualified Person (QP) declaration and/or label design that
requires approval—These must be included as part of the Clinical
Trial Application (CTA).
Release testing—Any time we include a manufacturing process
in the packaging program (e.g. Pre-filled syringe assembly,overencapsulation, pen assembly) there may be a quality requirementthat requires samples go through release testing. It is critical this beidentified up front as part of establishing the overall timeline.

The Fisher Clinical Services Project Manager with their multidiscipline
support team will lead you through the project requirements phase.
For the emerging biopharma company, that experience can proveinvaluable to establishing the assurance that the program will be
executed on time and at specification.

For example:
SPECIALIZED EQUIPMENT AND TOOLING
We have the expertise and capability to produce mostof this in-house. This enables us to provide you, thesponsor, the highest degree of flexibility while giving us
control of both cost and timing.

PACKAGING COMPONENTS
We have experience across a broad range of projects.
We understand which combinations work best, and canmake recommendations that will improve overall quality
and/or deliver predictable timelines.

MOCKUPS
They say a picture is worth a thousand words. Imagine whata 3-dimensional mockup might mean to ensuring processes
will work, and that procedures are thorough. Mockups canalso help with identifying where problems may arise, saving
time in the long-run. Our in-house engineering team is often
engaged to support through 3-D design projects.

LABELING
Our fully-integrated label production service eliminates theneed for an external vendor, where supply chain handoffsand the potential for missed deadlines can impact a project.
As an added bonus translation management is part of that
service, eliminating yet another potential external relationship.

VALIDATION
Because of the large volume of projects we have successfullycompleted, detailed validation processes can often beeliminated or streamlined. We’ve solved the problem before.

5Ensuring quality

Delivering experience

We understand that what we do matters. Throughthe work we perform on behalf of trial sponsors weare helping to bring hope to patients around the globe.
To that end, quality can never be compromised andthe patient always comes first.

No matter how large or small the project at hand, ittakes a team working as an extension of our client’sorganization to execute a successful program. To serve
as a trusted advisor requires open collaboration thatinvolves every discipline that will be part of delivering asolution. Quality, Engineering, Operations, Information
Technology, Client Services—each is an essential player
as part of the Project Manager’s team, offering theirunique expertise to ensure the solution will best serve
the client’s needs.

Ensuring the highest possible standard of quality is our corporate culture—
it is designed into everything we do.
•Being responsive to your needs is our top priority. Our experienced
quality leaders ensure we always provide transparent and opencommunication. We provide end-to-end quality oversight of every
facet of our programs and dedicate 10% of our staff to that function.
The end result is a zero recall operation that has stood the test of time.

•We manage our daily operations using comprehensive quality
management systems. Standard Operating Procedures are tightly definedand implemented globally. To make sure we stay on task we establish
Key Performance Indicators across the organization. In our production
areas these are constantly reviewed with team members so we remain
vigilant, proactively addressing things before they become an issue.

•Our Quality Management team supports an extraordinary numberof client and regulatory audits with very low levels of criticalobservations. In fact, we even offer a ‘virtual’ audit so that sponsors
requiring support from remote regions can conduct a detailed review
via on-line, real-time connections with our facilities and their staff.

•Continuous improvement is part of our daily routine. Whether investingin our people, systems or processes, our primary focus is to ensure
operational excellence that exceeds client expectations. We share ourclient’s passion for making an impact and improving lives. When weapproach each project with a ‘quality first’ mindset, we will design thebest possible solution to help ensure positive patient outcomes.

Over the years we have defined best practices that help us deliver consistent,predictable results. Processes have been standardized, project management
tools have been built and systems have been deployed so that our clientscan be confident they will get what they need in the timeframe that has beencommunicated. Our Project Managers coordinate internal communication
across all disciplines, keep track of milestones and timelines driving theproject to completion, engaging the client as needed. And for the client thatwants to remain connected throughout the process, our Global Gateway web
portal provides real-time visibility to status and inventory information.
While we understand it’s essential to deliver a project as it was defined,
experience informs us that it is equally important is to maintain a long view. We
constantly seek ways to refine and improve. Whether investing in new facilities,
next generation equipment or designing new capabilities through improved
systems and processes—we are deeply committed to ensure we stay one stepahead of our client’s needs both today, and in the years to come.

We share our client’s passion for making an impact and improving lives.
When we approach each project with a ‘quality first’ mindset, we will design
the best possible solution to help ensure positive patient outcomes.

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Published 09/21