Life Science Consulting Solutions

LIFE SCIENCE
CONSULTING
www.seuss.plus
We are dedicated to your life science success with CRO
and vendor selection, contract negotiations, governance
and oversight, and compliance management.

SYNERGISTIC SOLUTIONS THAT
DELIVER A MEANINGFUL IMPACT
About Seuss+
Seuss+ is a creative, hands-on, and
collaborative consulting firm serving the life
sciences industry. We focus on synergistic
solutions that deliver a meaningful impact
and we have a proven track record to help
you uncover and bridge gaps in your
biotech or pharma company's infrastructure
and team.
With our customer-centric approach, we
find a tailored solution for you, keeping your
timelines, budget, and clinical development
stage in mind.
Working as an extension of your team, we
serve as a catalyst for growth, innovation,
and greater profitability.
www.seuss.plus hello@seuss.plus +31 (0) 20 290 0016
OUR SERVICES
Together, we successfully drive your
product development.
Secure the best partners, get the most out of
your alliance, run your trials and projects
better and more smoothly, and challenge
the life-science collaboration status quo –
we promise you no less with:
CRO & Vendor Selection
Contract Negotiations
Clinical Trial Governance & Vendor
Oversight
Risk Management
Quality Management & SOPs
GDPR

Alignment Meeting
We guide you through the critical and complex
process of CRO and vendor partner selection,
with our rigorous approach driven by in-depth
data, quality, and cultural consideration. We
facilitate the process, so you can make an
informed and empowered decision.
RFP Analysis
We kick off the project with a
workshop designed to help your team
formulate and define the key selection
criteria.
After vendor responses are collected,
we analyze and compare strategies,
timelines, and cost structures to help
you make better decisions.
Market Scan Bid Defense
Through in-depth market research, we
identify vendors who match your
specific criteria for your RFP process.
We organize and facilitate your bid-
defense meeting, where defined
exercises ensure reliability from the
vendor candidates.
RFP Creation Contract Negotiation
We create a tailored RFP based on the
study synopsis, selection criteria, and
insights gathered in previous steps.
With our guidance and commercial
experience, we get you the best terms
and conditions in your new partnership.
CRO & VENDOR
SELECTION
WHAT TO EXPECT

The team provided excellent and professional
support during our vendor selection process. The
combination of deep industry experience,
operational knowledge combined with an
excellent network to draw upon allowed us to
make the final vendor selection decision on a very
strong and thoughtful decision foundation.
-Chief Medical Officer, Gene Therapy Company
Achieve Your Timelines
Focus on achieving your critical
timelines while we provide you
with the key insights, data
analysis, and information you
need to make your selection
decisions.
Ensure Compliance
We create an auditable
process, documenting all
necessary files and
decision-making processes,
so you are and remain ICH
GCP E6 (R2) compliant.
Comprehensive Comparison
We gather data-driven
insights to give you a
comprehensive and diverse
list of potential vendors,
facilitating direct comparison
for your decision-making.
Enabling you to build strategy-driven and future-focused
partnerships, and ensure compliance

Alignment Meeting
We make sure your negotiation is a
success, coordinating and supporting
you throughout your contract
discussions with selected vendors that
maximize your leverage and value.
Leverage Experience
We ensure team alignment in the
negotiation process to secure the best
terms and conditions for you.
We do the heavy lifting, challenging
your new partner’s assumptions to
ensure you get the best terms and
outcomes.
Document Review Facilitation
We identify gaps, highlight risks and
vulnerabilities, and suggest additions to
help you avoid unpleasant surprises.
We guide all parties involved through
a review of all documents to help you
secure a signed contract faster.
Budget Review Contract Signature
We know where to look to detect
budgetary inconsistencies and how to
track shifts in scope to allow you more
insight quickly.
We act as a third party, ensuring that
the scope of work is clearly defined
before the contract is signed.
CONTRACT
NEGOTIATIONS
WHAT TO EXPECT

The team once again successfully
guided us through these negotiations to
a very satisfactory conclusion! Really
appreciate your diligence and
expertise throughout the process.
- VP of Clinical Development at Drug Co-
Development Company
MAXIMIZE NEGOTIATION
LEVERAGE AND VALUE
Negotiation Effectiveness
We draw upon our
experiences and data-driven
insights to achieve optimal
agreements for you and
effective implementation.
Save Time & Costs
Strategize on key
milestones, KPIs, and
payment structure so
procurement doesn’t act as
a policing mechanism.
Nurture Relationships
Build and maintain the
relationship with your
vendor, while we challenge
the assumptions and
commercial terms.
We facilitate contract negotiations with your new partner under
extreme time pressure and high-stakes conversations.

The Challenge
Deficiencies in leadership, planning, resources,
capabilities, and budget have all been blamed for
many of the most dysfunctional clinical supplier
relationships and clinical trial issues.
In essence, it is a lack of control, limited foresight in
risks and issues, and miscommunication, which
actually cause these situations.
We see that vendors often lead governance
activities, and this potentially reduces the oversight
of the sponsor in spotting risks and issues.
If sponsors continue to outsource the direction and
leadership of their clinical trials, we will continue to
live these frustrating situations.
Sponsors must provide
leadership and direction to
all vendors involved in the
clinical trial or program.
Allowing governance
structures to be dispersed
across different vendors
within a single trial or
program puts too much
pressure on the sponsor team
to identify risks before they
happen based on disjointed
and incomplete information.
BUILDING STRONG
OUTSOURCING PARTNERSHIPS

We guide you through the complex
but critical process of implementing
manageable and executable
governance and oversight structures
to get the results you agreed to while
maintaining open and stable
relationships with your vendors.
Vendor Management
Implement the tools for effective vendor
management and oversight, ensure
quality & compliance, and create a
common understanding of the
objectives, timelines, and risk mitigation
plans.
Governance & Oversight
Mock Audit
From committee mapping and roles
and responsibilities to the most
effective meeting structures and
agendas, together we build a detailed
governance plan.
The best way to ensure you are ready
for an audit is by performing one. We
work with independent QA experts to
uncover potential gaps in compliance.
Performance Management
We help you create a detailed plan
of action, with clearly defined KPIs
and SOPs, fully oversight
documentation, communication
plans and tools for escalation.
CLINICAL TRIAL
GOVERNANCE &
VENDOR OVERSIGHT

This organized, dedicated, and
enthusiastic team goes the extra
mile to guide you to a final highly
data-driven decision, which meets
your business needs and serves as
a strong basis for the conduct and
delivery of outsourced trials.
- VP of Clinical Development at Drug Co-Development Company
Proactive Management
Create executable governance
and oversight structures across
your vendors, improving the
manageability, flow of
information, and protocol
changes.
Clear Decision Making
Adopt standardized processes
and custom plans that allow
you to cut down on time spent
in meetings, making better-
informed decisions more
quickly.
Assure Compliance
We give you the tools to
implement high-quality
standards across your vendors,
keeping you ICH GCP E6 (R2)
compliant and prepared for a
surprise audit.

The Sponsor's Responsibility
Our focus is on helping sponsors with their oversight
responsibilities by facilitating the development and
implementation of a risk management system to ensure quality
clinical trial results.
We work with you to establish and maintain a proactive risk
management strategy, letting you identify, track, and mitigate
risks before they impact your clinical trial and patient safety.
ICH-GCP E6 (R2) under section 5.2.2 requires the sponsor to ensure oversight of any
trial-related duties and functions carried out on its behalf.
However, many sponsors have expressed frustration with the difficulty of setting up an
oversight structure to monitor CROs because it is complicated and time consuming.
Therefore, outsourcing the development of an effective risk-based quality
management approach in clinical trials helps to ensure oversight and compliance with
ICH-GCP guidelines.
MITIGATE RISKS BEFORE
THEY BECOME ISSUES

We develop the processes and tools to establish and
maintain a proactive risk management approach, from
the set-up all the way through to the monthly
operations.
With our expertise, we take care of the possible
emerging risks, freeing up time so that you can focus
on the current situation, issues, and resolutions that
need your direct attention.
Risk Management Set-Up
Risk processes
Risk agenda
Monthly report template
Risk log
SOPs on risk management in order
to be audit ready
Setting up risk management consists of
developing the:
Risk Management Operations
The organization of risk meetings
Updating and monitoring the risk log
The development of the periodic
reports
Distributing information to the proper
channels
Identifying risks by reviewing sources
Assessing risk likelihood,
detectability, and impact
Determining the risk mitigation
approach
Following up on actions taken to
mitigate risks
As part of the monthly operations, we
facilitate:
This process involves:
1.
2.
3.
4.
PROACTIVE RISK
MANAGEMENT

Implementing quality management SOPs secures
the success of your study without delays by
providing a structured process to oversee the
project activities.
We bring an experienced team and a flexible
approach to building lean, fit-for-purpose quality
management systems for Biotechs.
QUALITY
MANAGEMENT &
SOPs
Different service levels tailored to your needs
Basic Service Level
The Basic service offering provides SOPs with a broad description of processes and key
QMS templates. These descriptions are to be adapted by sponsors with specific functions
and details of the process
Premium Service Level
Full Service Level
The Premium service level provides SOPs, key QMS templates, and templates to support the
SOPs. Seuss+ experts will adapt SOPs and templates to client processes in a cooperative way.
The Full service offering provides SOPs with a broad description of processes + key QMS
templates + additional templates to support the SOPs. Both SOPs and templates will need to
be adapted by the sponsor to reflect specific functions and details of the process.

This organized, dedicated, and
enthusiastic team goes the extra
mile to guide you to a final highly
data-driven decision, which meets
your business needs and serves as
a strong basis for the conduct and
delivery of outsourced trials.
- VP of Clinical Development at Drug Co-Development Company
Sponsor Team
Alignment
Standardize your vendor
oversight activities and lay the
foundation for sponsor team
growth and onboarding new staff.
Clear Oversight
Activity Instructions
Clearly define roles,
responsibilities, and processes
to mitigate risks uncovered
during oversight activities.
Be
Audit-Ready
Have documented proof of
your vendor oversight activities
and decisions to be audit-
ready at any time.
The QMS, built from an independent set of SOPs, provides guidance and
process documentation to ensure oversight and compliance without stifling
your innovation and flexibility.

GENERAL DATA
PROTECTION
REGULATION
(GDPR)
Ensuring the privacy of your data subjects when
processing their personal and health data is one of the
most important things you must do to comply with the
EU General Data Protection Regulation (GDPR).
We lead you through the process of implementing and
maintaining GDPR compliance measures in the most
pragmatic and cost-effective way
Needs Assessment
We start by taking inventory of your
organization’s data processing activities
and define your needs, whether you are
a sponsor or a vendor, and establish
the project scope.
GDPR Implementation
Internal GDPR Audit
All key stakeholders will receive a
clear implementation roadmap before
changes are carried out. We’ll also
create awareness across your
organization with a roll-out workshop.
We screen your existing data
processes and website as well as
internal documents related to GDPR,
ensuring they are complete, accurate,
and consistent.
DPO-As-A-Service
We offer a full-service Data
Protection Officer to help you
implement, maintain, and enforce all
necessary measures to remain GDPR
compliant.
Become and stay compliant with EU GDPR laws.

The Seuss+ team are professionals who
deliver high quality work in short time, while
being fun to work with. When your company
wants to be successful in the life-science
industry, this team is your perfect partner.
Managing Director, Biotech Company
Comply With
EU Laws
The EU is notoriously protective
of personal data privacy – our
GDPR packages make sure you
are and stay compliant with the
laws and regulations.
Demonstrate
Accountability
Enable an organizational
culture where employees deal
responsibly with digital systems
& information, and privacy is
an integral part of business
processes.
Create Clarity &
Transparency
We help you create clarity,
transparency, and certainty to
all stakeholders about how
personal data is processed and
protected by you.
GDPR FOR ORGANIZATIONS &
SPONSORS

We offer the total partner package: diving into the details of the way our clients work to help them create
better systems, prepare and manage trials, attract the best talent, the right trial subjects or customers, and
keep their employees and allies happy and performing at their best.
Talk to us.
Change life sciences, change the world.

Life Science Consulting Solutions

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