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