Unveiling the answers to the most burning questions in the business of the life science industry. In this slide, you will learn about selecting the best-fit CRO for your biotech company. Here is what you’ll learn: how to create the vision of your ideal CRO, how to have a Structured Process, how to anticipate and mitigate risks, techniques to promote and maintain Team Alignment, and the ins and outs of RFP Creation. Learn more about how Seuss+ can help you at our website www.seuss.plus

1. Top 5 best practices in CRO
selection for biotechs
Webinar

2. Selecting the best-fit CRO
is like choosing the right member for
your band

3. Welcome!
 Who is Seuss+
 What are the 5 Best Practices in CRO Selection for
Biotech
 Key Takeaways
 Seuss+ Vendor Selection

4. THE 5 Best Practices
4
Envision
Define yourself and
identify your trusted
partner
Team
Alignment
Understand each other's
needs and problems to
help create trust and
strength
RFP with Clear
Comparison
Create an RFP with
comparable data
Clinical Trial Success
Trust and Transparency
Structured
Process
Define the facts and then
follow your feeling
Risk
Assessment
Look to the future and
realise what can go wrong
and how to handle

5. Helping Biotech
companies strengthen
their assets, to prepare
for commercialization
or sale.

6. Life Science Consulting
Accelerate
Assets
We offer the complete spectrum of vendor
selection, vendor management,
governance, oversight, contract
negotiations, compliance, risk, marketing,
and strategy.
Organizational Development
Growth and
Change
Our multifaceted team of expert trainers
and organizational consultants navigate
you through the complex evolution of your
life science organization.

7. Health Economics and Management
European Director CRAcademy
Co-Founder and CEO of Seuss+
Global Director Business Development
Passionate about: Outsourcing Partnerships in Clinical Trials
Hello, my name is Kieran

8. Facts about outsourcing clinical partnerships
8
Source.clinicalleader.com & contractpharma.com
Top Challenges of a Sponsor-CRO Relationship
Sponsor: Transparency & Communication
CRO: Unrealistic Deadlines & Insufficient Information
64%
of clinical development services
OUTSOURCED

9. Outsourcing models
9
Sponsor Oversight
Sponsor Control
FSP / Multi-
Party
Subcontract Full Service
Insourced /
Freelance
In-House
Most Frequent Models for our Biotech Sponsors

10. CREATE THE
VISION OF
YOUR
IDEAL CRO

11. Cultural fit
11
SPONSOR
Map out the key milestones on
the critical path to filing
Identify CRO’s desired
personality traits
Reflect on your
company culture
Identify your Trusted Partner
CRO

12. Selection criteria
12
MEDICALMONITORING
SITE&COUNTRYSELECTION
[INDICATION]EXPERIENCE
PROJECTMANAGEMENT
DATAMANAGEMENT
15%
10%
30%
20%
10%
REGULATORYAFFAIRS
5%
QUALITY
5%
CRITERION&QUANTIFY
Provide guidance to the CRO
Frame the needs that lead
to clinical trial & business
success
Help maintain consistent focus
on the important attributes

13. Reality check
13
Are the behavioural
traits of the CRO
realistic?
Is the previous
experience of the
CRO realistic?
Define preliminary KPIs and
provide these in the RFP.
How will you measure if the
selection criteria are met?

14. TEAM
ALIGNMENT

15. A misaligned sponsor team = unclarity
15
Identify and
capture main risks
Create team
engagement for
informed decision
making
Unify the vision,
action and
language

16. ONE ALIGNMENT METHOD
16
Roles
Respon
sibilities
Balance, alignment & expectations
Accurate Costing
360-degree Strategy
Define scope & envision future activities
RACI

17. STRUCTURED
PROCESS

18. Bring the Brain & heart into harmonious
alignment
18
Brain
Heart
Kick-off
Meeting
Q&
A
RFP
Evaluation
Bid
Defence
Contract
Signed
Evidence-based
and informed
decision-making
First, find the CROs
with the right facts,
Then, trust.

19. Create A process that infuses value
19
2. MARKET RESEARCH
3. RFP CREATION
4. RFP ANALYSIS
5. BID DEFENCE
6. DECISION TIME
7. CONTRACT
NEGOTIATION
8. PARTNERSHIP
MANAGEMENT
1. ALIGNMENT MEETING
Time Quality Cost Scope

20. RFP
CREATION

21. Create an RFP that SELECTS AND STIMULATES COMPARISON 21
Do you have experience with asthma
studies?
Please list your specific Asthma Phase III
study experience since 2012.
Question:
Traditional RFP Process RFP Process within our Practice
Answer: We have extensive experience in conducting
national and international clinical trials in a wide
variety of therapeutic areas, including Asthma.
With this experience, we have many best
practices and lessons learned that we plan to
apply to this study. Over the past five years, we
have conducted over 5 Asthma trials involving
more than 2,400 patients at over 400 sites globally
[…]
Proportion of
“Symptoms X” 8/18 1/8
2/4 2/5
Proportion of
“Method Y” Studies
1/18 1/8
1/4 1/5
Paediatric
patients
13/18 5/8
3/4 4/5
Number of
[Indication] Studies 18 8
4 5
Mock Data
• Much information, and at times irrelevant
• Difficult to draw data-driven conclusions
Outcome:
Primary
Indication/
Secondary
Indication
Route of
administra
tion
Severity Level # of Sites
# of
Patients
Services Awarded
Year
started
Year
completed
Paediatric
patients
included?
Asthma
Inhaled,
pulmonar
y
Mild to
Moderate
persistent
18 45 CO, PM 2014 2016 Yes
Asthma
Inhaled,
pulmonar
y
Mild to
Moderate
120 200
CO, PM, Clinical Logistics, Patient
Recruitment, Site Initiation and Qualification
2013 2016 Yes
Asthma
Injectabl
e,
subcutan
eous
Severe 510 5,970
CO; DM; PM; MM; PV; RA Biostatistics;
Clinical Logistics; Electronic Data Capture;
Feasibility; IVRS; Medical Writing; Patient
Recruitment; PI Customer Care; PI Portal;
Publication; RTSM; Site Qual/Init
2009 2017 No
Asthma
Injectabl
e,
subcutan
eous
Severe 200 1,751
CO; DM; PM; MM; PV; RA Biostatistics;
Clinical Logistics; Electronic Data Capture;
Feasibility; IVRS; Medical Writing; Patient
Recruitment; PI Customer Care; PI Portal;
Publication; RTSM; Site Qual/Init
2010 2015 Yes

22. Types of questions
22
Quantitative /
Table format
Case study questions with
lessons learnt
Challenge us, as
critical thinking area
Easy to compare
Insight into CRO experience
Display how CRO adapt to situations
Shows understanding of study’s challenges
CRO is able to teach & provide recommendations
CRO not able to tell their story
Difficult to compare between CROs
Uncertain about the actual lessons learnt
No comparison possible between CROs
Create a mix of different type of questions & cross-comparison
Use quantitative questions to crystallise prior experience
Open questions can be useful to capture strategy and learnings

23. Bid grid 23
0 40
30
20
10
Number of roles
listed
0 16,000
12,000
8,000
4,000
Hours worked
$0 $2.8 M.
$2.1 M.
$1.4 M.
$0.7 M.
Total cost ($M.)
Biggest expenses Time (hrs.) Cost ($)
Monitoring Visits 7,759 $1.309 M.
Site Communication 2,313 $0.388 M.
TMF Maintenance 1,462 $0.117 M.
Clinical Team Com. 699 $0.101 M.
Consult. for Safety Issues 318 $0.098 M.
Biggest expenses Time (hrs.) Cost ($)
Monitoring Visits 5,200 $0.887 M.
Site Communication 2,966 $0.405 M.
Rev. of Monitoring Reports 1,657 $0.306 M.
CRF Rev. & Query Mgmnt 1,213 $0.20 M.
Add. Monitoring Visits on
Site
903 $0.147 M.
Biggest expenses Time (hrs.) Cost ($)
Site Communication 4,772 $0.701 M.
Monitoring Visits 1,702 $0.279 M.
Central Monitoring Units 1,418 $0.228 M.
Clinical Team Com. 782 $0.126 M.
Payment of Investigators - $0.082 M.
$2.17
M.
$2.22
M.
$1.45
M.
13,4 K
hrs.
14,4 K
hrs.
8,9 K
hrs.
CRO 1 CRO 2 CRO 3
CRO 1 CRO 2 CRO 3
Compare apples
with apples
Overview of CRO
strategy
Create trust in your
decision
Easy to present to
board

24. RISK
ASSESSMENT

25. Embracing risk to grow &
innovate
25
What can be the specific reasons
this trial will FAIL?
Develop cross-functional risk assessment,
establishing consistency across studies in a
programme and throughout its life cycle
Identify and assess protocol-level risks, aligning
your expectations about CROs contribution and
mitigation plan

26. Vendor management 26
Governance
Framework
Consistent Process
& Automation Tools
Risk Management Cicurlarity
Ensure consistency in the
process from the RFP promise
through the execution and final
delivery. Use automation tools
for oversight to stay on top of
your game.
Classify your vendors and
intergrate the risk management
across the journey - not only at
the beginning and end. Assess
the value of your vendors
consistently and invest in
strategic relationships.
Operate, oversee, optimise
throughout the study or
programme life cycle to learn,
grow and innovate.
Start with a governance plan,
determining your vision and
articulating your vendor
management plan & overight to
all parties involved.

27. KEY
TAKEAWAYS

28. Key takeaways / Return on investment
28
Vision
Team Alignment
Structured Process
RFP with
Clear Comparison
Risk assessment
5
4
3
2
1
Be in full control
Focus on the essence
Be ICH E6 (R2) compliant
Trust
&
Transparency

29. Seuss+
Vendor
Selection

30. Seuss+ vendor selection
30
Support & Coordinate the CRO evaluation, utilizing a
robust process geared towards putting the Sponsor in the
driver’s seat.
Provide clear guidance through
analysis and the creation of
visually strong documentation to
identify best-in-class vendors.
Facilitate Sponsor-CRO decision making by defining critical
selection criteria, creating team alignment and providing a
clear selection process.
CLARIFY & ALIGN SUPPORT & ORCHESTRATE ANALYSE & DOCUMENT

31. 31
Seuss Consulting 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.
Christian Meyer, MD, PhD -
Chief Medical Officer at uniQure
Seuss Consulting was more than 100%
engaged in setting up a very professional
vendor selection process. The thorough
preparation based upon a very pleasant
collaborative interaction and good
understanding of the clinical operational
field as well as a rigid follow-up during the
process resulted in a strong evidence-
based decision for selecting the final
vendor.
Peter Suenaert, MD, PhD -
Chief Medical Officer at Immunicum

32. THANK YOU
www.seuss.plus
Seuss+ hello@seuss.plus
Watch the full webinar replay for free right now:
https://www.seuss.plus/blog/webinar-5-best-practices-
in-cro-selection-for-biotech/

33. “We believe that building
a robust partnership
model is grounded in the
identification of trusted
vendors and long-term
partners who share your
values, strategic goals,
and ambitions.“

34. Seuss+ is a collaborative and trusted
international life science consultancy. We
creatively solve complex business challenges
so our clients can focus on what they do
best—science.
We support drug development program
success and organizational growth through
our unique partner approach and portfolio
of tailored and strategic business solutions.
Unraveling complex business
challenges in life sciences

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36. Webinar
Top 5 best practices in CRO
selection for biotechs