Clinical Outsourcing Strategy & Approach -

back to basics for effective delivery and

oversight

Rupert Dixon

Director Clinical Development

Clinical Operations, Global Medicines Development

FSO Model with Multiple Partners

Outsourcing in Clinical Trials UK 2015

Topics

AstraZeneca delivery landscape and scope

Where did we want to get to?

Back to basics approach

Progress to date

What next?

2

AstraZeneca Delivery Landscape

Patient Safety

Regulatory

Analysis

Reporting

Data Mgmt

Many Support Service Providers e.g. Labs, IVRS etc....

CRO Monitoring

Pharma Company Monitoring

CRO Full Service Number /type of CRO partners dependent on a pharma companys clinical outsourcing

strategy

Clinical Trial Supply Pharma & external partners

Many interfaces requiring collaboration and different levels of governance

SD CSP FSI Value Chain LSI DBL CSR

AROs & Collaborative Groups (CGs)

Deliver Design Decide

The Brief

Single, defined model and pool of providers for all full-service outsourcing through CROs

End-to-end service, from study set-up to report writing and submission-ready study deliverables. Some activities out of scope (labs, ECG etc)

Late stage interventional studies including oncology and immuno-oncology, infection, neuroscience and all paediatrics.

Flexibility to include studies in other TAs

4Q 2013

4

5 5 5

Where We Were - Q4 2013

Baseline organisational

capability

Outsourcing Strategy & Operating

Model

Processes

People

Significant AZ resource

being applied to FSO delivery

CROs not empowered to use

own Processes &Technology

AZ oversight variable

User experience (AZ & CRO) of

existing FSO model variable, and not

universally positive

AZ -Perceived lack of flexibility and

control

CRO Lack of empowerment

Variable confidence

that studies will

deliver to time & cost

Quality is fit for

purpose

Lack of consistent,

transparent

performance

measurement

6 6

Desired Future State: 2016

Leading capability

Outsourcing Strategy and

Operating Model

Processes

People

Goal: maximise the speed, quality and cost

effectiveness of clinical trials delivered by our

CROs . Studies consistently delivering upper

quartile performance

Maximise use of provider

processes & technology

Optimise AZ resource

requirements, focus on right level

of oversight

Key interface roles with appropriate

skills, behaviours & capacity

Consistent and positive AZ customer

experience

CROs view AZ as a sponsor of choice

Evidence of value adding innovation

delivered via collaborative working

Model that evolves to meet

changing requirements

Smart allocation of work to

providers in competitive,

performance-based relationships

Commercial framework that

drives performance with better

value

7

Allocation

Provider capabilities

Project requirements

Delivery

KPIs

Healthchecks

New

Providers

Discontinued

Providers

Feedback

Baseline provider

distribution

Potential future

provider distribution

Clear work allocation process, driven by performance and capability

Competition and incentivisation built in, to drive value and delivery, and to access innovation

Transparent sharing of portfolio and performance

Dynamic, Performance-driven model with

multiple providers and smart work allocation

Underpinning Principles

Back to Basics

Ensure requirements are clear and agreed

Good Governance

Clear, objective measures. & actions

Early engagement

Simplification

Partnership behaviours = treat people the way that you would want to be treated

8 Author | 00 Month Year Set area descriptor | Sub level 1

Ensuring Requirements are Clear and Agreed

Know who the customers are, as compared to stakeholders

Requirements are not wishes

Requirements are what not how - You are paying provider for expertise & capability

9 Author | 00 Month Year Set area descriptor | Sub level 1

Dynamic, Performance-driven Model with

multiple providers and smart work Allocation

Good Governance

. ensure that an organisation or partnership fulfils its overall purpose, achieves its intended outcomes for service users [customers], and operates in an effective, efficient and ethical

manner*

10

Study level oversight

Day to day operational oversight (time, cost and quality)

Risk and issue management

CRO

(AZ/CRO Governance)

Portfolio level oversight for each CRO (ie.time, cost , quality, relationship health and continuous improvement)

Risk & issue management

FSO

Cross-functional

Governance Team

Active management of FSO model, work allocation, performance and alignment to principles

Refresh CROs

FSO Dashboard

Balanced Scorecard

Health check (two-way)

Study level Performance/issues

Customer feedback

INFORMATION FLOW

Changes in requirements

Continuous improvement

Innovation priorities

INFORMATION FLOW

Portfolio forecast

Issue escalation

Study level innovation

* Independent Commission on Good Governance in Public Services (!)

Clear targets and measures leading

& lagging across time, cost, quality &

customer/supplier satisfaction

Collaboration to drive performance is

essential

Decisions on work allocation based on

objective performance data -

commercial consequences

11

Customer/Supplier satisfaction

% milestones achieved

meet upper quartile intervals targets

% budget variance

evidence of cost management

% delivery of critical to quality requirements

audit findings

Clear, Objective Measures. & Actions

Early Engagement

Maximises opportunity to optimise relationship

12

Applies at model and study level

Opportunity to clarify & challenge your requirements

Tap into expertise and experience

Requires desire to use provider input

Simplification

External Provider Management

Team Manual

Provider MSAs, Study Contracts

AZ SOPs and OPIs

Provider MSAs, Standard Description

of Services and Study Contracts

AZ SOPs and Guidance Docs

Procedural Simplification and

Standardisation

Manual Decommissioning

Schedule 1:

Description

of Services

Clinical Operations Other Functions Clinical Operations Other Functions

Standard Description of Services (DoS)

Before After

Minimum Requirements

for Oversight, Processes,

Standards & Systems

CO PS B&I Reg Etc

20 Process Topics

MSA per CRO Study Contracts Scope of Services per

CRO

DoS

Navigator

Partnership Behaviours

Grounded in AZ organisational values

14 Author | 00 Month Year Set area descriptor | Sub level 1

15 15 15

Where are we now?

Building organisational capability in

Alliance Management

Outsourcing Strategy & Operating

Model

Processes

People

Guidance information &

documentation developed

Forum for best practice sharing and

highlighting issues

Agreement to measure health of

relationships

Performance driven Operating

model implemented

3 Providers on-board

>30 Studies underway

Governance model designed &

implementation underway

Performance Measures & targets

agreed across all CROs

Commercial framework designed

& MSAs executed

Single Description of Services

agreed across all CROs

staged, planned refinement

Provider processes & technology

under adoption

Whats next ..Change Management

16 Author | 00 Month Year Set area descriptor | Sub level 1

What next?

Help realise the benefits

Drive Change Management

Assess Governance Effectiveness

Improve access to user friendly guidance material

Drive consistent performance data

Develop & deliver just-in time education

Revisit the customers is model meeting expectations?

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Thank you,

Questions?