Deconstructing challenges faced with working with CROs and effective processes to overcome them Managing the process of relationship development with the right CRO to reduce unnecessary consumption of time Unveiling mistakes and understanding the best way to work with CRO’s to strengthen relationships with your current and new vendors Emphasizing the importance of coordination and communication and how that benefits your work load and organization of preclinical trials

1. Eyal S. Ron, Ph.D.
3rd Annual Preclinical Development Operations Summit 2018
November 14, 2018
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2. Agenda
 Deconstructing challenges faced with working with CROs and effective
processes to overcome them
o Managing the process of relationship development with the right CRO to
reduce unnecessary consumption of time
o Unveiling mistakes and understanding the best way to work with CRO’s to
strengthen relationships with your current and new vendors
o Emphasizing the importance of coordination and communication and how
that benefits your work load and organization of preclinical trials
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3. Overview
Pharma & Biotech companies learned how to focus on core competencies and
not focus on the parts that divert a company from cultivating its skills, parts
its vendors could make more efficiently
 Internal
Focus on those activities that are critical
to the core and that the company is
distinctively good at
• Outsourcing
o Outsource components where vendors
have a distinct comparative
advantage—greater scale,
fundamentally lower cost structure, or
stronger performance incentives.
o Use outsourcing as a means of
generating employee commitment to
improving performance.
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4. Challenges Faced with Working with CROs
 Multiple groups within the company pursue conflicting outsourcing
strategies (lack of coordination )
 Fear of being exploited by opportunistic vendors.
 Lack of an appreciation for the opportunity cost of resources (“we can
do it all” mentality, in effect, depleting the limited energy)
 Employees are concerned that outsourcing will “hollow out” the
company
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5. Managing the Process: Strategic and
Nonstrategic Relationship
 Identifying a high-quality vendors that are matched with the
organization (technically, culturally, size-wise, etc. )
 Which activities will be indispensable to the company’s competitive
position over subsequent product generations?
 Opportunity to interview key stakeholders and bridge the gap between
the vague aspirations that launch a project and the concrete,
measurable requirements that guide it to successful conclusion
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6. Request for Proposal (RfP)
A request for proposal (RfP) is a solicitation, often made through a
bidding process, by an agency or company interested in
procurement of a commodity, service or valuable asset, to potential
suppliers to submit business proposals. It is submitted early in the
procurement cycle, either at the preliminary study, or procurement
stage
https://en.wikipedia.org/wiki/Request_for_proposal
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7. Steps - the RfP Process
Internally:
o Establish the project's boundaries (define what you want to
achieve out of the outsourced relationship)
o Identify key stakeholders and advisors
o Define your project needs (protocol or protocol synopsis)
o Project timelines
o Date the RfP is issued
o When questions are due
o Pre-proposal conference date
o When suppliers’ responses are due
o Draft the RFP
▪ Create a draft of the scoring criteria
▪ Review with the team (stakeholders and advisors)
Externally:
o Select 3 – 5 vendors
o Submit RfP to the vendors
o Provide Project timelines
o When questions are due
o Pre-proposal conference date
o When suppliers’ responses are due
o Review and discuss the proposals (Externally &
Internally)
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8. The Vendor’s Prospective
 RFP's are a chance to look at clients and their project descriptions /
needs before any contracts are signed.
 Gives a vendor greater independence in choosing who to serve.
 Put Yourself in the Vendor’s Shoes
o Are there any gaps?
o What follow up questions might the vendor have?
 Hold a Pre-Proposal and Teleconference

9. Request for Proposal’s Specifications
 The RFP Should Make Introductions. The RFP should provide basic introductions to your company (who is
requesting the proposal)
 The RFP Should Present the Need. The RFP should provide a brief project overview, stating the business case for
the project and the need to be filled. (Project Description / Objectives)
 The RFP Should State Requirements. The RFP should state the service and technical requirements and
specifications upon which the proposed solution must be based. Every requirements statement should include a
"definitions" section to ensure that all parties share a common understanding of all business and technical needs.
▪ Questions and required information
o A “Killer” criteria
o Questions based on past experiences
▪ Technical items: eDC, Statistics, randomization, pre-selected sites, additional vendors (labs?), interim analyses, etc.
 The RFP Should Set Terms and Conditions. The RFP should state the expected terms and conditions for solutions
acceptance, including delivery requirements, payment terms, and regulatory requirements.
▪ Timeline (timeline for Proposal but also for Milestones / Deadlines)
▪ Fee structure
 The RFP Should Set Expectations. The RFP should describe the overall RfP bidding process, including response
submission requirements, "winning" evaluation and selection criteria, process deadlines, and related technical
procedures (response format, submission mechanisms and how to submit questions and feedback).
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10. Evaluation Criteria
Primary
 Quality of vendor
 Timeline
 Cost
Secondary
 Quality of communication
 Project leader
 Do they “get us”?
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11. Evaluate Proposals
by Alex Lichtenberger • Allgemein, IT Governance 11

12. Unveiling Mistakes and Understanding
the Best Way to Work with CRO’s
 Oversight Metrics / Benchmarks
 Risk Management
 Oversight Plan
 Risk Mitigation
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13. Oversight Metrics / Benchmarks
 Is the vendor doing what we hired it to do?
 Is the vendor adhering to the plan?
 Is vendor performance meeting or exceeding expectations?
 What issues should be escalated?
 Why are we behind schedule?
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14. Risk Management & Oversight
 Risk assessment
 Risk identification
 Risk analysis
 Risk control that includes decision
making to reduce and/or accept risks
“Not everything that can be counted counts, and not
everything that counts can be counted.”
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What might go wrong?
What is the likelihood (probability) it will go wrong?
What are the consequences (severity)?

15. The Importance of Coordination and
Communication
 Is having multiple vendors cheaper?
o Each vendor is cost effective when compared with a single multiple-
activities' proposal
o Strategic (key) specialized vendors - high value, low volume and sole-
source
o Some vendors may have a problem with working openly with others
thinking that sharing operational and financial information leaves them in
a weaker position
o Unifying SOP’s / operation maybe a challenge
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16. Outsourcing Overload
• Consider that:
o It is more difficult to nurture profitable vendor relationships with too many
vendors
o There maybe a poor or no focus on managing the performance
o Difficult to agree and set measures of tracking and therefore a lower chance
for improvements

17. Outsourcing Overload – Cont.
 Benefits of consolidation of vendors:
o Lower costs – limiting the number of vendors will increase the buying
power
o Time – managing vendor relationships takes a lot of time
o Decreased risk - more vendors means additional contracts. Managing
many contracts means a greater risk of non-compliance.
o Better service – when focusing on a limited number of preferred vendors,
they will be more serious about providing a higher level of service.
o Relationship – it is easier to focus on building a profitable vendor
relationships.

18. Ideal Vendor Number – a Compromise
 Consolidation of different vendors under a single preferred project
leader / vendor
 Define the goals that you want to achieve out of the consolidated
relationships
 Delegate project management responsibility to the preferred vendor
(and the contractual responsibilities)

19. Summary - Cultivating the Most
Beneficial Vendor Relationships
 The RfP Process is One Approach to Start a Constructive Vendor
Relationship
 Draft a Quality Agreement, Oversight Plan and Risk Management
Plan that Prescribed Standards, Expectations, and Responsibilities
 Outsourcing Overload? Consolidate the Different Vendors Under
a “Single Umbrella”
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20. MADASH, LLC.
THANK YOU
Eyal S. Ron, Ph.D.
eyal@madash.com
https://www.linkedin.com/in/madash
@EyalSRon
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