Vendor-Sponsor Successful of Obligations CRO Responsibilities CRO applies standardized tools trackers CRO controls / manages day-to-day activities CRO collates

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  • Vendor-Sponsor Successful Communication

    Nathalie Dutil

    Nov 2012

  • Lack of communication Miscommunication

    Its 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!