Project Delivery

Excellence
Raising the
bar in project
success

Contents
Raising the bar in project success 02

Tailored training and development 03

Project planning and management for predictable delivery 03

Optimised balanced resourcing 03

Smart start 04

Proactive risk detection and mitigation 05

Next steps 06

ICONplc.com
1
Raising the bar in project success ICON’s project delivery is driving
Metrics that matter industry leading metrics today:
The escalating complexity of clinical trial projects is

3.5
threatening the ability of many sponsors to complete
programmes on time and within budget with quality

months
data. Pressures such as stricter regulations, changing
technologies and globalisation are stressing current
operational models and information infrastructure to the
limits. As these pressures will only intensify, applying
a rigorous methodology to anticipate and navigate the median cycle time from Protocol
hurdles that arise during the course of modern clinical Approved (PA) To First Site Initiated
trials is the only way to increase project success. (FSI). Beating industry median of
4.2 months**
ICON’s methodology for project delivery gives clients a

25%
novel, best-in-class approach to improve cycle times,
constrain costs and reduce risks amid the intricacies
of today’s clinical trials.

Our methodology combines the following components potential reduction in monitoring costs
to deliver project commitments. with Patient Centric Monitoring
- Deployed successfully in 45+ studies
– Tailored staff training and development programmes

90%
– A range of innovative technologies and tools for real
time data analytics
– Continuous business process improvement
– Governance models suited to clients’ of trials meet or beat Last
individual priorities Patient Randomised (LPR)

Tufts research* has found, that a 10%

improvement in cycle time and success rates
can shave $634 million off the total capitalised
cost of $2.6 billion required, on average, to
bring a new drug to market.

*Tufts - Innovation in Drug Development Process Remains a Key Challenge 2015

**KMR - Industry median 4.2 months
2

Project
Management
Academy
Tailored training and development
Skills development with distinction
Our specially designed training and development
programme supports ICON’s project managers to
attain the competencies that are essential to
consistently exceed expectations amid the increasingly
intricate environment of today’s clinical trials. The
programme develops the capabilities to anticipate and
navigate the hurdles that may arise during the course
of a project.
A behavioural skills assessment taken by each project
manager informs the development of a customised
training programme that addresses a wide array of
critical situations and governance models. This instils
an agility to adapt to unique organisational structures
and to manage a scale of varying projects, from single
service to complex global programmes.
The programme covers key competencies including:
– Cross-Functional Leadership
– Communication
– Project Planning, Organisation and Control
– Risk Management
– Execution and Performance
– Customer Relationship Management
– Drug Development Knowledge
ICONIK - A powerful integrated information
platform consolidates, standardises and
visualises operational and clinical data from
multiple sources to provide a single holistic
view of study information.
90%
of Projects
Meet LPR
Project planning and management for
predictable delivery
Using big data analytics and innovative tools
The project manager is equipped with big data
analytics for project planning and early risk detection
to help them develop plans that address potential
problems specific to the client’s programme.
With access to ICONIK, the project manger is able
to monitor progress in near real-time, enabling rapid
decision making, ongoing risk identification and to
proactively mitigate and reduce risk through adaptive
responses. Issues, big and small, can be addressed
before they impact on project success leading to more
predictable delivery for our clients.
Optimised balanced resourcing
The right people in the right places
Conventional models for trial resource management
often fail to anticipate the balance of staff necessary
which can lead to insufficient or unsuitable resources
being assigned.
ICON operates an advanced model, based on
predictive analytics and a longstanding initiative for
continuous improvement, to resource projects with
the right capacity in appropriate locations and with the
right balance of expertise in indication and function.
Our project managers create and maintain resource
demand plans and submit timely requests according
to project requirements. The Planning and Resource
Management (PRM) team at ICON centralises
global oversight for clinical resourcing to provide
clients with highly qualified and therapeutically
aligned staff. PRM assesses availability of staff and
forecasts future staffing needs, making specific hiring
recommendations to meet project obligations.
Applying targeted recruitment allows our team to
identify skills and expertise demand, assess staff
competencies, and provide clients with the optimal
balance of indication and monitoring experience
across each study team. PRM fulfills resource
requests within 5 working days 97% of the time.
3
Smart start
Pushing efficiency in study start-up

Inefficient processes in study start-up can impede progress that can

lead to loss of valuable time and impact the overall delivery schedule.
Accelerating study start-up is essential to increase the likelihood of
meeting key project milestones.

ICON has adopted a range of Leading edge technology and tools

streamlined processes and procedures
to advance site activation:
– Reduced site selection time through the provision of teams to complete the specific documents and tasks
specially designed databases and tools
– Introduced efficiencies in contract negotiation
(Clinical Trial Agreements) process
– Enhanced study start-up planning capabilities and single area for exchanging documents, recording
oversight to ensure milestone achievement
– Introduced a Critical Document Pack quality
management system to track and identify root
causes for quality issues
– Simplified the operational model to minimise hand-
offs and provide greater accountability
for deliverables
– Invested in industry-leading technology to enable
workflow and document collection
By automating time consuming activities we have also
fostered enhanced communication between sites and
project teams.
ICON applies a leading edge purpose-built software
solution that automates many study start-up activities.
It provides country-specific workflows to guide study
required for site activation, whilst tracking progress
automatically. Providing status updates and critical
path reports in real-time, it enhances collaboration
between study teams and sites by providing a
and updating tasks, monitoring submissions and
communicating updates for study start-up.
ICON also uses analytic tools to provide real-time
visibility into start-up across multiple studies and
regions. This enables the project team and clients to
discover meaningful patterns in study start-up data
and also quantify study team performance.
By combining streamlined processes with industry-
leading tools in study start-up, ICON saves clients
time and cost in their development programmes, with
reduced cycle times in study start-up

3.5 Months
median cycle time
from Protocol
Approved (PA) to
First Site Initiated. Beating industry
median by almost
a month*

* Industry median 4.2 months according to KMR, a global

leader in benchmarking, analytics and performance
4
Proactive risk detection and mitigation
Patient Centric Monitoring

A primary driver of costs can be attributed to site and patient monitoring.

While monitoring methods such as 100% source data verification (SDV)
have long been the standard in clinical trials,TransCelerate has evidenced
the limited value of the practice: only 7.8% of total queries and 2.4% of
critical data queries were identified using these methodologies.

Recent technological advances in Patient Centric Monitoring is ICON’s methodology for

electronic data, and regulatory guidance
regarding data quality, enable clients
to choose a more targeted, risk based
approach to site monitoring and data
handling beyond prior standards.
Experience in 45+ studies in multiple
therapeutic areas
the design and execution of an adaptive risk based
monitoring strategy using ICONIK data analysis. The
approach focuses on risk detection, mitigation and
the prevention of errors by focusing on activities which
have the greatest potential to improve patient safety
and data quality.
Highly skilled professionals proactively identify and
manage the range of risks that arise in modern, multi-
centre clinical trials using proprietary technology and
tools; ICONIK for real-time data analytics and ECAT
(Error Capture & Analysis Tool) for detecting risks
earlier so that root cause analysis and human factor
characterisation assessment can be performed.

Patient Centric Monitoring also enables the rapid

identification of site-specific solutions, such as
allocating additional resources or addressing
underlying cultural serial factors that would not be
resolved with other risk based monitoring offerings.
This proactive early detection and mitigation of
risk brings the benefit of more effective resource
25% deployment and the potential to reduce monitoring
costs by up to 25%.
Potential Reduction
in Monitoring Costs

Patient
Centric
Monitoring

5
Next steps:

We understand the strategic impact that project delivery has on your business. That’s why we have
developed effective project management processes that measure the risks highly and monitor
progress to ensure your projects are delivered in line with your organisational priorities.

With more than 25 years of experience helping a range of organisations successfully achieve their project objectives
across a wide variety of therapies, we have the capability to deliver your project on time, within budget and to the
highest quality.

If you would like to learn more about our approach and discuss your next project please contact us, using the
details below.

By focusing on the improvement of metrics that matter we are already delivering economic value to
our clients.

Metrics that Matter

TIME QUALITY COST

Metrics Metrics Metrics

– Study Start-Up – Customer Satisfaction – Monitoring Cost

Cycle Times

– Last Patient
Randonmised

Corporate Headquarters
South County Business Park
Leopardstown
Dublin 18, Ireland
Tel: +353 (1) 291 2000
Fax: +353 (1) 291 2700
Enquiries@iconplc.com

ICONplc.com Version 1 April 2016

6