Developing and maintaining strong relationships between the Sponsor and the selected CRO can make or break a clinical study. In this webinar, two experts with experience managing clinical programs from both a CRO and a Sponsor perspective provide tips and strategies for optimizing these relationships using real world examples.

1. Optimizing
Sponsor/CRO
Relationships

2. Introduction: Kristen Snipes
Experience:
• 18 years in Drug Development
• 13 years experience at CRO in various roles in both
clinical operations and project management
• Over 10 years of project management experience
• Experience managing analytical method development,
formulation, IND filings (including CMC) and Phase 1-4
clinical trials at a Sponsor Company
• Focus in CNS, cardiology, and dental indications

3. Introduction: Jamie Arnott
Experience: 22 years in healthcare as a
practitioner and in clinical research
• 12+ years in project management
• 10 years experience at CRO in clinical operations and
project management
• 6 years experience as Director, Clinical Trial Operations at
a Sponsor company
• Focus in oncology, orphan indications, and infectious
diseases
• Experience managing and providing oversight for all
clinical activities for multiple concurrent INDs

4. Overview
The Ideal
Relationship
Communication The Conversation
Oversight Reporting
Financial
Management
Case Studies Keys to Success

5. Key Factors in CRO- Sponsor
Relationships
Communication
Reports
Financial Management
Oversight

6. Ideal Relationship
Characteristics that make up good,
healthy working relationships
Trust
Mutual respect
Mindfulness
Welcoming diversity
Open communication
Single point of contact

7. Manners/Business Etiquette
Be on time
Be responsive and reliable
Follow through
Appropriate technology use
Business writing
Phone usage
Body language

8. Sponsor Needs
Clear communication pathways
Points of escalation
Timelines
Risk identification
Confirmation of key staff
Transparency
Information for upward reporting

9. CRO Needs
Clear directives
Point of contact
Unified messaging
Collaboration
Identification of stakeholders and decision makers
Whose SOPs/processes are we following?

10. Communication
Method
Format requested by Sponsor
Concise and accurate
Appropriate frequency

11. Preparing for the Negotiation
Consider communication styles and adapt if necessary
Define the exact outcome you want
Consider the likely desired outcome of the person you’re working with
• What do they say they want? What do they really want?
Consider the underlying interests of those involved
• Why do they want what they want?
• What lies behind the position they are stating?
Create a list of the interests of those involved and prioritize

12. How to Identify Interests
Understand each
perspective
Listen
Ask Open Ended
Questions
• Why? What? How?
Listen
Consider which
interests might
stand in the way of
agreement
Listen

13. Open Ended Questions
Why is that
important to you?
What is important
to you about
that?
What will having
that do for you or
the project?
What is
meaningful to
you about having
that?
Why do you think
that would be
best?
What impact will
that have on you
or the project?

14. The Conversation
Establish
Rapport
Create comfortable
environment for
discussion
Build Trust
Discuss the
Problem
State your
understanding of the
situation
Ask open-ended
questions to gain
understanding
Start with general
questions to find
common interests
Demonstrate your
understanding of the
interests of others
Propose
solutions
Suggest solutions that
address key interests
Be clear about options
Remain open to fresh
ideas
Advocate your interests
and listen

15. The Conversation, continued
Establish
Agreement
Identify general
solutions both
can agree to
Discuss and
agree to specific
actions
Ensure goals are
SMART
Confirm
Commitment
Define actions
needed and who
is responsible
Agree how to
monitor progress
and evaluate
Conclude
Conversation
Highlight
successes of
discussion
Emphasize
common
interests that
lead to
conclusion

16. What if something goes wrong?
• Ask more general open questions
• Go back to common ground
No Agreement
• Ask other person for their assessment
• Suggest continuing another time
Conversation
seems stuck
• Pause; take a deep breath
• Consider ending conversation
Discussion
becomes
heated

17. Communication Summary
Identify objectives/task owners
Give input/feedback
– Don’t always agree
– Alternative options
– Be involved in developing the study plan/strategy
Be transparent
Be prepared to say no if a request will NOT be met
– Don’t say yes because it’s easy at the time
– Evaluate alternative options
– Evaluate what is limiting the team from saying yes
Be respectful and professional

18. Oversight
ICH E6
Sponsor
Requirements
Balance
Project plans
Visibility is key
for all parties

19. Documentation of Oversight
Communication:
• Team effort
• Not micromanaging
• Not clean handoff and walk away
• Reassess Project Plans
Documentation:
• How will you demonstrate?
• How is this proven to regulatory
authorities?
• Escalation and risk identification
• Revise Project Plans as assumptions
change

20. Reporting
What’s
standard
What’s needed
Frequency Format

21. Reporting Process
Determine study reporting requirements
Implement study reporting process
Complete periodic re-evaluation of study
reports
Adjust reporting frequency or content
Implement revised reporting process

22. Financial Management

23. Pharmaceutical R&D Spending
• A recent estimate took large pharma’s R&D budgets divided by drugs
approved 1997-2011 give costs ranging from $3.7 Billion per Drug (Amgen)
to $11.8 Billion per Drug (AstraZeneca) InnoThink Center for Research in Biomedical Innovation
$11.8 BILLION !

24. Budget
Review assumptions in study budget
Be aware of key program drivers
Identify stakeholders and process for change
orders
Transparency and clear communication

25. Case Study: PM Parental Leave
• Good standing relationship in place
between PM at Sponsor and CRO
• PM to head out of parental leave
• Interim PM assigned
Change in Primary contact for 6
months

26. Case Study: To the Rescue!
• CRO has been awarded a rescue study
pulled from another CRO
• Timelines are crunched
• Site frustration
• Site confusion regarding point of contact
for study activities
• Sponsor unhappy
Sponsor awards rescue study

27. Case studies: Site Selection
• Needing to add sites to boost
enrollment
• Budget implications
• Timeline impact
Enrollment boost needed

28. Case Study: Unfavorable
Outcomes
• After 2 year enrollment and treatment,
data results are released and aren’t
favorable
• Relationship critical to weather bumpy
results
• Confidence in execution and data
deliverables
• Work to determine additional analyses
required
Study Results are released

29. Case Study: Client Management
• SIVs before IRB approval
• Site staff may differ
• Sites forget study once it is time to enroll
• Retraining = $
• Lack of focus on your study = $
• Create study plans with draft protocol
• Rework = $
• Confusion/mistakes
Impact when Sponsors do things out
of order

30. Keys To Success
Make personal connections
Active listening
Stay informed
Key factors
– Cost
– Quality
– Time