Risk Management – Good vibrations › phuse › 2017 › ma › MA01_ppt.pdf · Aligning Metrics...

© Copyright 2017 Chaucer / www.chaucerlifesciences.com 1 / CONFIDENTIAL© Copyright 2017 Chaucer / www.chaucerlifesciences.com CONFIDENTIAL

Risk Management – Good vibrationsPhUSE 2017

© Copyright 2017 Chaucer / www.chaucerlifesciences.com 2 / CONFIDENTIAL© Copyright 2017 Chaucer / www.chaucerlifesciences.com 2 / CONFIDENTIAL

Risk Management • The art of good vibrations

© Copyright 2017 Chaucer / www.chaucerlifesciences.com 3 / CONFIDENTIAL

A risk under the magnifying glass

Based on

uncertaintyExist in the

future

More things

might happen

than will happen


Risks vs Issues

Risks

• Might happen

• Uncertainty

• Pro-active

Issues

• Is happening

• Certainty

• Re-active

• Can become an issue

• Can be a former risk

impact on

objectives


Elements of a risk – The risk bow tie

Cause

Cause

Consequence

Consequence

Consequence

Consequence

Risk event

What can trigger the risk? What can happen if the risk occurs?

Proactive actions Mitigation actions

Recovery actions


Probability Impact Severity

Understanding the risk


Risks are not individual problems in a confined space

Risk

Risk

Risk

Risk


The key to success is a well-crafted web


The elements of a risk spider web

Risk Appetite Statement

Risk Culture

Risk Management Strategy

Risk Management Plan


Risk Management is a effort


Benefits of a great working spider web

Increase the likelihood of realising objectives

Build confidence

Comply with relevant legal and regulatory requirements

Improve resilience and quality

Optimise allocation of resources

Improve organisational learning


Risk Management is the art of

good vibrations

© Copyright 2017 Chaucer / www.chaucerlifesciences.com 13 / CONFIDENTIAL© Copyright 2017 Chaucer / www.chaucerlifesciences.com 13 / CONFIDENTIAL

Risk Management in Clinical Trials


ICH E6 (R2) – New Good Clinical Practice


ICH E6 (R2) – our challenges

The regulators don’t have a consistent understanding of risk

The industry doesn’t understand what risk is and how to manage it.

Agencies will mature their own interpretation over time .

Everyone is starting from a different place

Cultural change takes longer as we have a history of managing issues rather than risks

Each organisation has their own interpretation of the guidance


Risk Management as an Opportunity

ICH E6 (R2) is an opportunity to implement risk management

Through risk management we can prevent unpleasant surprises

It is not just about being compliant

Increase the quality of our programmes through Quality by Design

Take control over cost and resources when risks turn into issues

Learning cycles will support improved process and trial design


RISK MANAGEMENT needs to become part of our DNA


Interpreting ICH E6 (R2)

System Level

• CROs & Vendors• SOPs• Computer Systems• Facilities • Study Design

• Protocol Development• Investigators Role

Trial Level


Risk Breakdown Structure (RBS)

Aligning Metrics with business need

Data, Metrics &Performance

Quality Management System

Aligning Standards

OrganisationStructure

Documentation

On-Boarding BusinessProcesses

Audit &Compliance

CROSelection

Clinical Trial Conduct

InspectionReadiness

• Social• Technological• Economic• Environmental• Political• Legal• Ethical

CRO GCP Quality Risk

Macro –Environment

Factors


Pro-active management enables efficiency

Low

High

Time

Proactive Risk Management

Cost of implementation

Potential for mitigation


Rev

iew

5.0.6 Risk Review

Co

ntr

ol

5.0.4 Risk Control

Adapted Process Flow ICH Q9 (consistent with Addendum ICH E6)

Risk Management Framework – Learning Cycle

Co

ntr

ol

Res

po

nd

Ass

ess

Create Risk Breakdown Structure

Risk Identification

Risk Analysis

Risk Evaluation

Risk Reduction

Risk Acceptance

Output / Results of RM Process

Review Events

Ris

k C

om

mu

nic

atio

n a

nd

Rep

ort

ing

Ris

k M

anag

emen

t To

ols

Un

acce

pta

ble

5.0.1 Critical Process and Data Identification

5.0.2 Risk Identification

5.0.3 Risk Evaluation

5.0

.5 /

7 R

isk

Co

mm

un

icat

ion

an

d R

epo

rtin

g


Different levels of risk

• Social• Technological• Economic• Environmental

CLINICAL PROGRAM

BUSINESSLEVEL

MACRO ENVIRONMENT

• Business Objectives• Operational Objectives (Cost, Quality, Time)

• Study Set-up• Study Conduct• Study Closure

• Political• Legal• Ethical

Risk is at the heart of what we do

TIME

COST

QUALITY


The Risk Bow Tie – an example

Trai

nin

g

Reputation

$$$

Power of Trial

Tho

rou

gh

inve

stig

atio

n

What can trigger the risk? What can happen if the risk occurs?

Controls / Proactive actions

Mitigation actions

Recovery actions

Insufficient Systems

Another cause

Syst

em

up

dat

es

Po

licie

s

Ch

ange

m

eth

od

s

Take

ou

t in

vest

ig.

Tigh

ten

d

etec

t.

met

ho

ds


Multiple connection points, many people

handling data

Sensitive data is disclosed

Vendors’ use of service providers

Loss of sensitive customer data

Regulatory fines

Classifying data for business or regulatory use

Causes

Early warnings for data compromise

Preventative actions / controls

Mitigation Actions Consequences

Risk example

Human error in documenting data

Limited options for vendor selection

Data loss prevention techniques (DLP)

3rd parties to adopt data controls on safeguarding

Vendor assessment process

Data encryption controls

Employee training and refresher education

Checking & verification processes in place

Review sourcing strategy

FDA approvals delayed

Integrity of trial compromised

Time contingency plans

Evidence of oversight in TMF

Extend clinical trial


25

20

15

10

5

Risks over time

Time related information will support better prediction of risk…

Time


Technology in Action – the Risk Bow Tie


Heatmaps Provide a Great Focus for Clinical Teams


Risk has many facets


Taking full advantage of ICH E6 (R2)

…of processes to effectively identify and evaluate risk

STANDARDISATION

Implementation of an aligned framework

RISK MGTFRAMEWORK

INDEPENDENT MANAGEMENT

across you as the sponsor and your vendors/CRO’s.

risk register, presentation of risks,

profiles and risk scores.

TOOLS

methods and toolset

TRAINING

Employee involvement towards proactive risk

management

CULTURE


In the middle of difficulty

lies opportunity. Albert Einstein

Risk Management – Good vibrations › phuse › 2017 › ma › MA01_ppt.pdf · Aligning Metrics...

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