Optimizing Sponsor/CRO Relationships

Introduction: Kristen SnipesExperience:• 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

Introduction: Jamie ArnottExperience: 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

OverviewThe Ideal

Relationship Communication The Conversation

Oversight Reporting Financial Management

Case Studies Keys to Success

Key Factors in CRO- Sponsor Relationships

Communication

Reports

Financial Management

Oversight

Ideal RelationshipCharacteristics that make up

good, healthy working relationships

TrustMutual respect

MindfulnessWelcoming diversityOpen communicationSingle point of contact

Manners/Business EtiquetteBe on timeBe responsive and reliableFollow throughAppropriate technology useBusiness writingPhone usageBody language

Sponsor NeedsClear communication pathwaysPoints of escalationTimelinesRisk identificationConfirmation of key staffTransparencyInformation for upward reporting

CRO NeedsClear directivesPoint of contactUnified messagingCollaborationIdentification of stakeholders and decision makersWhose SOPs/processes are we following?

CommunicationMethodFormat requested by SponsorConcise and accurateAppropriate frequency

Preparing for the NegotiationConsider 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

How to Identify InterestsUnderstand

each perspective

ListenAsk Open Ended Questions• Why? What? How?

ListenConsider which interests might

stand in the way of agreement

Listen

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?

The ConversationEstablish 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

The Conversation, continuedEstablish

Agreement

Identify general

solutions both can agree toDiscuss 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

What if something goes wrong?• Ask more general open questions• Go back to common groundNo Agreement

• Ask other person for their assessment

• Suggest continuing another timeConversation seems stuck

• Pause; take a deep breath• Consider ending conversation

Discussion becomes heated

Communication Summary Identify objectives/task ownersGive input/feedback

– Don’t always agree– Alternative options– Be involved in developing the study plan/strategy

Be transparentBe 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

Oversight

ICH E6 Sponsor

Requirements

Balance

Project plansVisibility is key for all

parties

Documentation of OversightCommunication:• 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

Reporting

What’s standard

What’s needed

Frequency Format

Reporting ProcessDetermine study reporting requirements

Implement study reporting process

Complete periodic re-evaluation of study reports

Adjust reporting frequency or content

Implement revised reporting process

Financial Management

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 !

BudgetReview assumptions in study budgetBe aware of key program driversIdentify stakeholders and process for change

ordersTransparency and clear communication

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

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

Case studies: Site Selection

• Needing to add sites to boost enrollment

• Budget implications• Timeline impact

Enrollment boost needed

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

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

Keys To SuccessMake personal connectionsActive listeningStay informed Key factors

– Cost– Quality– Time