vendor-sponsor successful communication · transfer of obligations cro responsibilities cro applies...

Vendor-Sponsor Successful Communication

Nathalie Dutil

Nov 2012

Lack of communication Miscommunication

It’s all about setting expectations….

Presentation overview

• Strategic Sourcing

• Oversight Model

• Trust & Verify Relationship

• Oversight components

• Communication Plan

• Country Management Plan

Why outsource?

Strategic Sourcing

• What is Strategic CRO Sourcing Achieve optimized outsourcing operating model

while maintaining quality and advantageous economics

Objective Build a best-in-class advanced model for outsourcing to drive

improved

– Study delivery

– Quality

– Cost efficiency

Principles of Strategic CRO Sourcing

Features of the CRO Strategic Sourcing Model

CRO Strategic Sourcing – Key Characteristics

• Governance

– Acceptance Criteria and partnership metrics

– Strategic and Management Operating Committee

• Transfer of Obligations

– Functions transferred to CRO

– Utilize CRO SOPs/systems

CRO Strategic Sourcing – Key Characteristics

• Utilization of Sponsor Resources

– Efficient utilization of sponsor resources

– Functional plans/Service Level Agreements

– Reduction in Effort and Time

• No competitive bidding

• Milestone based contracting

• Reduce change orders

Sponsor Responsibility CRO Responsibility

The Other party verifies

the activities to confirm

that actions required to

achieve the outcome were

taken and outcome has

been achieved

Trust and Verify Relationship

One party to the

agreement undertakes

various activities

designed to achieve a

mutually agreed outcome

Concept used to describe a relationship in which

SPONSOR – CRO: Trust and Verify Relationship

The concept serves as the framework within which

• the partnership processes, tools, templates are designed • key performance indicators are defined

Embracing Trust

Collaboration with the CRO requires that the Sponsor builds trust by partnering effectively

For Sponsor, trust is contingent upon: •CRO success in meeting timelines •Producing quality data •Resolving issues through solution focused action plans

For CRO, trust depends on: •Sponsor engaging in a sincere partnership •Sponsor providing critical responses and information to CRO •Timely and in a decisive manner •Collaboration in sharing best practices in issue resolution

Components of Strategic Sourcing Model

Budget

Timelines

Deliverables

Items Evaluated During Oversight

Quality

Financials

Supported by:

Scope

Transfer of Obligations & Master Services Agreement

Strategic Sourcing Model: Components

CRO applies standardized tools & trackers

CRO controls / manages day-to-day activities

CRO collates issues with proposed solution strategies

CRO uses internal processes & expertise

Performance measure

Enables the Sponsor and CRO teams to

initiate a protocol with an understanding of

CRO accountability and responsibility for

protocol deliverables and in accordance with

the scope documents

Master Services Agreement And Transfer of Obligations (ToO)

Master Services Agreement & Transfer of Obligations

CRO applies standardized tools & trackers

CRO controls / manages day-to-day activities

CRO collates issues with proposed solution strategies

CRO uses internal processes & expertise

Performance measure

Quality Agreement - MSA

• Operational Principles

• Project Management

• Qualifications of CRO Personnel, Training Expectations

• Procedural Requirements

• Monitoring Activities

• Study Files/Documentation

• Third Party Vendor Qualifications Process

• Quality Metrics

• Audit Process

• Sponsor/CRO QA Collaboration

• CRO QA Internal Audit Program

• Inspection Readiness

Master Services Agreement & Transfer of Obligations

CRO Responsibilities

CRO applies standardized tools & trackers

CRO controls / manages day-to-day activities

CRO collates issues with proposed solution strategies

CRO uses internal processes & expertise

Performance measure

Apply standardized

tools & trackers

Control/manage day-

to-day activities

Collate issues &

propose solutions

Use internal

processes

Ensuring Strong Performance and Continuous Improvement: Tools

• Trust and verify points

• Governance structure

• Portal access to Sponsor Advisory teams to view:

- Sponsor selected status reports

- key lab and clinical data

• Dashboard metrics

• Acceptance criteria

• Quality agreement

• Planning and Strategy sessions (between CRO and BMS)

• Safety Monitoring Plan

• Database quality audit

• Medical Management Plan

Performance Measures

Master Services Agreement & Transfer of Obligations

CRO applies standardized tools & trackers

CRO controls / manages day-to-day activities

CRO collates issues with proposed solution strategies

CRO uses internal processes & expertise

Performance measure

Data quality audits

Query rates

Number of protocols violations/serious breaches

Enrollment rates

Low enrolling sites

Compliance audit findings

Monitoring Visit Frequency

Report metrics

Effective communication through detailed communication plan

Building a strong virtual team where everybody is aware/valued

Clear process for escalation and resolution of issues

Communication Plan = Quality Relationship

Communication Plan

• Governance – Responsibility for Oversight

• Local Points of Contact Network – At Sponsor and CRO

• Operational Execution – Feasibility and Site Selection

– Study Start-Up

– Regulatory Operations

– Project-Specific Information Management

– Local Medical Oversight

– Inv. Product and Ancillary Supply Logistics

• Quality and Training

• Local Sourcing

Country Management

Study Start-up

• Local Sponsor-CRO kick-off meeting

– Country/site feasibility

– Site Selection process

– Site Start-up activities

– Health Authority submissions

Study Start-up: What could go wrong?

• Site selection by CRO not aligned with sponsor recommendation

• Number of sites not clearly defined

• Challenges with site contracts

Sponsor Responsibilities

• Site Selection process

• Define Protocol deviations

• Clinical Drug supply packaging, labeling & randomization

• Health Authority submissions

CRO Responsibilities

• Finalize country/site feasibility

• Site Start-up activities/Contracts with sites

• Initiate discussions with Sponsor Legal

• Develop project plan/charter

• CRO portals and management trackers/tools

Patient Enrolment, Treatment, Data Clean-up

• Country and Site Activation

• Patient Recruitment

• Data Collection, review and cleaning

• Safety monitoring

• Site monitoring/management

Patient enrolment: What could go wrong?

• Patients difficult to recruit

• GCP/Quality issues at sites

Sponsor Responsibilities

• Continued operational and data management oversight

– Monthly review

– Ad hoc meetings

– Quality Oversight visits

• Lessons learned forum/ Regular face-to-face meetings

CRO Responsibilities

• Patient recruitment implementation

• Data Review

• Communicate risk/issues

Local sponsors & local CRO team members must know each other = trust

Schedule planning & strategy meetings with cross-functional stakeholders early

Mutual sharing of information / guidance documents (country library, CRO portal)

Hold Lessons Learned meetings with local CRO at major study milestones

Escalation of risks/issues

Road to Success

Thank you!