Dr Maria AliHead, Medical and Safety Services

George Clinical

Overview:Part I: Setting the stageWhere - EnvironmentWhy - Perceived benefitsWhat - ComponentsHow - Enablers

Part II: CRO / ARO perspectiveExperiencesChallenges

PART I

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

Where? Regulatory Environment

FDA

EMA

ICH

MHRA

Where? Initiatives

Public-private partnershipOver 60 organisations

Quality by Design

Clinical Trials Transformation

Initiative Collaboration of global biopharmaceutical companies

Risk Based Monitoring (one of 5 initial goals)

Transcelerate Biopharma

Why RBM?Enhanced subject

protection

Improved data quality

Reduced trial costs

What is RBM?

Centralised Monitoring

Remote Monitoring

On-site Monitoring

Risk Assessment and Planning

How?

EDC

EPRO

EHR/EMR

eSource

eICF

CTMS

PART II

RBM experience at George Clinical

• Risk based monitoring of commercial studies• Risk based monitoring of academic studies

Considerations and Challenges

BUSI

NES

S CO

NTE

XT •CRO size•Market•Geography•Resource investment

PEO

PLE

•Training•Change Management

•Breaking silos

PRO

CESS

ES

•Protocol Development: Access and involvement in process

•Re-engineering traditional team structures

•Communication Sponsor – CRO -Site

TECH

NO

LOG

Y

•Enabling technologies

•Sources of data•Choice of critical risk indicators few vs. many

•Vendor / solution selection