Project Delivery Excellence

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Moses Ward
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1 Project Delivery Excellence Raising the bar in project success 1 ICONplc.com

2 Contents Raising the bar in project success 03 Tailored training and development 04 Project planning and management for predictable delivery 04 Optimised balanced resourcing 04 Smart start 06 Proactive risk detection and mitigation 08 Next steps 10 2

3 Raising the bar in project success Metrics that matter The escalating complexity of clinical trial projects is threatening the ability of many sponsors to complete programmes on time and within budget with quality 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 hurdles that arise during the course of modern clinical trials is the only way to increase project success. ICON s methodology for project delivery gives clients a 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 to deliver project commitments. Tailored staff training and development programmes A range of innovative technologies and tools for real time data analytics Continuous business process improvement Governance models suited to clients individual priorities ICON s project delivery is driving industry leading metrics today: 3.5 months median cycle time from Protocol Approved (PA) To First Site Initiated (FSI). Beating industry median of 4.2 months ** 25% potential reduction in monitoring costs with Patient Centric Monitoring - Deployed successfully in 45+ studies 90% of trials meet or beat Last 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 3

4 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. 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. 4

5 Project Management 90% of Projects Meet LPR 5

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.

6 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 streamlined processes and procedures to advance site activation: Reduced site selection time through the provision of specially designed databases and tools Introduced efficiencies in contract negotiation (Clinical Trial Agreements) process Enhanced study start-up planning capabilities and 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 handoffs 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. Leading edge technology and tools ICON applies a leading edge purpose-built software solution that automates many study start-up activities. It provides country-specific workflows to guide study teams to complete the specific documents and tasks 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 single area for exchanging documents, recording 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 industryleading tools in study start-up, ICON saves clients time and cost in their development programmes, with reduced cycle times in study start-up 6

7 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 7

8 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 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 Patient Centric Monitoring is ICON s methodology for 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, multicentre 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 deployment and the potential to reduce monitoring costs by up to 25%. 8

9 Patient Centric Monitoring 25% Potential Reduction in Monitoring Costs 9

10 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 on the back page. 10

11 By focusing on the improvement of metrics that matter we are already delivering economic value to our clients. Metrics that Matter TIME Metrics Study Start-Up Cycle Times QUALITY Metrics Customer Satisfaction COST Metrics Monitoring Cost Last Patient Randonmised 11

12 Corporate Headquarters South County Business Park Leopardstown Dublin 18, Ireland Tel: +353 (1) Fax: +353 (1) ICONplc.com Version 1 April 2016

CGMA Competency Framework

CGMA Competency Framework Technical skills CGMA Competency Framework 1 Technical skills : This requires a basic understanding of the business structures, operations and financial performance, and includes