1. Dr Maria Ali Head, Medical and Safety Services George Clinical

3. Overview: Part I: Setting the stage Where - Environment
Why - Perceived benefits
What - Components
How - Enablers
Part II: CRO / ARO perspective
Experiences
Challenges

4. PART I

5. Where? Clinical trial environment
Number and complexity of molecules discovered / discovery methods
Number of trials
Complexity of trial design
Complexity of patient populations, more sites with less patients, wider geographic locations
Completion time and cost of trials

6. Where? Regulatory Environment
FDA
EMA
ICH
MHRA
ICH: (1996) E6 notes flexibility in monitoring approaches
MHRA: (2011) Medicines and Healthcare Products Regulatory Agency (UK)
Real Time Process Monitoring / Process Analytical Technology (FDA guidance for pharma manufacturing) – manufacturing industry – data points in isolation vs. data points in the context of other related data points

7. Where? Initiatives Public-private partnership
Over 60 organisations
Quality by Design
Clinical Trials Transformation Initiative
Collaboration of global biopharmaceutical companies
Risk Based Monitoring (one of 5 initial goals)
Transcelerate Biopharma
ICH: (1996) E6 notes flexibility in monitoring approaches
MHRA: (2011) Medicines and Healthcare Products Regulatory Agency (UK)
Real Time Process Monitoring / Process Analytical Technology (FDA guidance for pharma manufacturing) – manufacturing industry – data points in isolation vs. data points in the context of other related data points

8. Enhanced subject protection
Why RBM?
Enhanced subject protection
Improved data quality
Reduced trial costs

9. Centralised Monitoring
What is RBM?
Centralised Monitoring
Remote Monitoring
On-site Monitoring
Risk Assessment and Planning

10. EDC
EPRO
EHR/EMR
eSource
eICF
CTMS
How?

11. PART II

12. RBM experience at George Clinical
Risk based monitoring of commercial studies
Risk based monitoring of academic studies

13. Considerations and Challenges
BUSINESS CONTEXT
CRO size
Market
Geography
Resource investment
PEOPLE
Training
Change Management
Breaking silos
PROCESSES
Protocol Development: Access and involvement in process
Re-engineering traditional team structures
Communication Sponsor – CRO -Site
TECHNOLOGY
Enabling technologies
Sources of data
Choice of critical risk indicators few vs. many
Vendor / solution selection
CRA role – elevation of view point from ‘subject-level’ to ‘study-level’
Compliance groups and their concerns
IQRMP – Components of all plans to work in harmony, not executed in isolation
Importance of feedback loop and continuity of the process after monitoring has been executed