Enhancing the CRO-Sponsor
Collaboration to Ensure High
Quality of Clinical Data
May 17,2011 | Beijing, China
Charles Yan, PhD
Shanghai Clinical Research Center
Agenda
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Potential Advantages and Risks for Outsourcing
Outsourcing for Clinical Data Management
Considerations in Selecting a CRO
Key Factors for High Data Quality
Best Outsourcing Relationship
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Potential Advantages for CROs
• Reduce:
– Time to develop and commercialize a new drug
– Sponsor’s fixed costs with personnel, equipment and facilities
needed for its clinical development
• Provide:
– Ready access to needed expertise and/or technology
– Greater access to potential investigators
– Knowledge of regulatory climate in foreign markets
Drug Information Association
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Potential Risks of Outsourcing to CROs
Reduced control of the clinical trial process by the Sponsor
– Delays in completion of studies
– Lost or poor data quality
– Regulatory infractions produce indirect consequences
• FDA regulations/GCPs
• Fraud and Abuse
– IP
Outsourcing for Clinical Data Management
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Data Management Plan
CRF Design, Annotated CRF
Database Setup and Edit Check Development
Data Entry and Discrepancy Management
Lab Data Management
AE/SAE Management
Coding (MedDRA + WHO DD)
Database Locking
QC and QA
Electronic Data Capture
Site User Training, Administration and Support
EDC： Site Guides
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Considerations in Selecting a CRO
• Company information
– Historical overview of the organization,
– Length of time in the industry,
– Financial stability of the organization
– Organizational structure
• Products and services
• Experience
• Product demonstration
• Commercial
– Business sustainability
– Cost of services
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Considerations in Selecting a CRO
• Compliance
– Understanding of global regulations(FDA, SFDA, etc)
– Archiving system
– Quality systems and proof of compliance to their quality requirements
– Quality assurance
• Documentation of system validation for regulated processes
• Evaluation of the vendor’s QC/QA process
• Disaster/contingency plan(s) to protect business operations
• Adaptation to sponsor’s SOPs
• Results of previous regulatory inspections
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Considerations in Selecting a CRO
• Capacity and Flexibility
– Expansion with changing needs
– Resources to deal with uncertainties
– Handling additional assignments
• Capability and Credibility
– Diversity of experience
– Experienced people
– Adequate facilities
– Training and incentives for people
• Confidentiality
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Considerations in Selecting a CRO
• Documentation change control processes
• Review of required accreditation
• Personnel qualification, job descriptions, organizational charts,
training plans etc.
• Data transfer process
• References from previous customers
• Outcomes of previous regulatory inspections
• Security of physical locations where services are provided (server
rooms, file rooms, etc.)
• The number of sponsors or studies currently supported by the
available CRO staff
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www.diahome.org
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Key Factors for High Data Quality
• Detailed start-up meetings （ face-to-face）
– Overview of the whole program
– Ensure that processes for both companies are described in detail (SOPs
and training)
– Define the roles and responsibilities for sponsor and CRO
– Discuss expectations of both teams in regard to deliverables, timelines and
resource
– Communication and decision-making strategy
– Issue resolution process
– Budget planning and management
– Expectations and performance metrics
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Key Factors for High Data Quality
The Most Common Sources of Conflict
In recent industry survey, both Sponsor and CRO agree that the top
sources of conflict are related to mismatched expectations.
– Pharma: 88% agree
– Service Providers: 92% agree
For Sponsor
For CRO
Expected innovation does not materialize
Expected volumes do not materialize
Scope changes lead to additional costs
Changes in requirements lead to
increased & unrecoverable costs
Off-contract purchasing undermines
expected savings
Customer does not provide committed
resources
Project delays due to supplier
Project delays due to customer
Quality problems
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Key Factors for High Data Quality
Define Acceptable Metrics in Data Management
（Time, Cost, Quality and Quantity)
Data Management Process
KPI
Study prepare phase
—CRF design duration
—Database setup duration
Study conduct
—CRF received->Data entry
—Data entered -> query generated
—Query generated-> query reviewed
—Query resolution time
—LPLV-> database lock
Study closeout
—Error Rate (data entry, CRF vs database)
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Key Factors for High Data Quality
At Study Setup Phase
To clearly define the roles and responsibilities for DM CRO
Data Management
Task Description
Sponsor
CRO
Data Management Plan
CRF Design and Annotated CRF
Database Setup
Validation Program
CRF tracking
Data Entry
Discrepancy Management
Coding (MedDRA or WHO DD or both)
. ..
Drug Information Association
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Key Factors for High Data Quality
At Study Conduct Phase
To have a good communication channels (weekly basis or as needed)
CRO
Sponsor
Report any findings during study conduct Decision maker on any issues reported
Or approval for the actions
Submit weekly progress report
―Summary data quality
―CRF pages received
―CRF pages entered/cleaned
―Missing and/or expected CRFs
―Queries sent/outstanding/resolved
As reviewer
―Focus on QA or QC
―Safety and efficacy data
Interim Analysis
Timeline
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Key Factors for High Data Quality
At Study Closeout Phase
To follow database lock procedures and to lock database on time
CRO
Sponsor
Database lock
Timeline for Database lock
Prepare DB lock checklist
―All data entered
―Any open query
―SAE reconciliation
―Coding
―QC
―…
—Special query handling
—Data quality review
—SAE reconciliation resolving
—Database locking approval
Lock database and dataset
transferring
Check all docs completed and signed
―Paper CRF
―Datasets
―DMP
―…
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Best Outsourcing Relationship
• Understand, learn and respect each other
– Careful selection and detailed contract vital for a long term successful
relationship
– Sponsors need to carefully assess the requirements of CRO
– CRO needs to understand expectations of sponsor
– Mutual benefit from the relationship
– Support from senior management
• Set measurable goals and objectives
– Performance measurement and feedback
– Periodic, formal and fact-based relationship
– Progress review process in place
• Communications and conflict resolution process
• Feedback and evaluation
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Thank you!
Q&A
Contact info: chongchao.yan@scrcnet.org
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