What is a Project? A project is a temporary effort undertaken to create a unique product or service Temporary: Every project has a definite beginning and end. Unique: The product or service is different from all similar products or service. PMBOK, 1996
Types of Project Capital investment Service/supply contract delivery Research and discovery Product development (facilities, engineering, manufacturing etc.) Process/systems development (IT, health & safety, security, environmental etc.) Organisational change
Major Stakeholders Customer (Scope and Quality requirements) Multiple possible users Project manager Responsible for managing project Performing organization Supplier of work or services Investigators and sites Regulatory Others Contractors, suppliers, owners, agencies, pressure groups, media, etc.
Managing the project A clear focus on deliverables Direct involvement of sponsor and other stakeholders Structured scope of work and planning for execution Clear roles and responsibilities for team members Controlling activities and change control procedures Delivery within agreed parameters
Scope of Work (SOW) The Scope of Work (SOW) is the principal document for transmitting the customers project requirements. The SOW usually contains: Written description of the project requirements Assumptions on study deliverables, timelines, milestones Responsibilities of the Buyer (customer) and the Seller (PPD) Technical or performance specifications Deliverables and acceptance criteria Project budget and payment schedule Scope change (change order) process Communication requirements
Life-Cycle Definition Projects have a beginning and an end Projects are a sequence of tasks & activities This sequence is known as the Project Life-Cycle For management purposes, the life cycle is divided into phases Phases usually correspond to a deliverable and/or milestone
The Life Cycle and Project Management Processes Level of Activity Phase Start-up Phase Close-out Time Initiating Processes Planning Processes Executing Processes Controlling Processes Closing Processes PMBOK, 1996
Milestones Milestones represent a significant event in the project major interfaces between phases represent a single point in time (not duration) may be an event without which the project can not progress enable progress reporting when achieved provide feedback to the team
Review Project Closeout Hand-over to PM Project Start-up Win Bid Bid Process Project Implementation Hand over Business Development Project Manager Project Sponsor Board - policy formulation Management - planning & operations BUSINESS AS USUAL TIME Generic Project Lifecycle
Project Initiation RFP BD review bid/no bid Proposal document Timescales Budget Bid/Proposal Defence Finalized Proposal Scope of Work/ Final Budget Incorporate any appropriate changes BD HandoverFull and comprehensive handover of project to the Project Manager Project Manager takes full ownership of project PPD awarded the project Signed contract Contract Award ActivityMain TasksEnd Results Develop full proposal and budget PM Review and agree If Bid - Proposal strategy meeting Formal presentation of proposal to customer Initial project plan Proposal Produce feasibility document Obtain feasibility data from operational groups Feasibility Study
Five Types of Budget Fixed Budget (FIX) a risk that that CRO will complete work for which it will not be compensated Fee for Service Budget (FEE) least financial risk for CRO Fee for Service w/cap Budget (CAP) if CAP is going to be exceeded, Project Manager must ensure contract modified to include additional work
Six Types of Budget Unit Based Budget CRO is paid based on a completing a specific number of Units or tasks Outcomes Based Budget Greatest risk, but could be the greatest gain LOI
Stage I: Proposal and bid Defense Project initiation: Key clinical events: -Возможность проведения проекта- Capability and/or feasibility including potential regulatory and ethical risks Цель: -разработать стратегию проекта -идентифицировать риски -Определить реалистичное количество исследовательских центров/пациентов
Stage II: Planning and Site Identification Project Planning: Key clinical events: -Feasibility/Site ID Цель: -Финализировать прогнозы по набору пациентов -Финализировать количество стран и исследовательских центров
Stage III: Site Start Up and Activation Project Execution and Control Key clinical events: -Процесс селекции центров -Сбор документов для инициальной подачи(site and country level) LECs and SEC -Сбор IP release документов -Активности по подписанию контрактов -Митинг исследователей/CRA тренинг -Активности по импорту и экспорту -Визиты Открытия Центров (SIVs) - Цель: -Инициация первого центра согласно плану
Stage IV: Patient enrolment -initial progress Project Execution and Control Key clinical events: -1st patient in -Мониторинговые визиты (SMVs) -Внимание к ресурсам, соблюдение мониторингового плана по 1м визитам Цель: -Мониторинг начального прогресса включения центров/пациентов
Stage V: Patient enrolment Project Execution and Control Key clinical events: -Enrollment data analysis -Increase/decrease frequency of visits (if applicable) -Implementation of recruitment strategies, if any -Закрытие базы данных. Промежуточное и основное (DBLs) Цель: -Включение последнего пациента согласно графика
21 Why Focus on Recruitment? Did you know that….. 25% of sites open for enrollment NEVER enroll a single subject. 75% of sites open for enrollment enroll a maximum of
Stage VI: Project close-out and archiving Key clinical events: - Визиты закрытия центров (SCVs) - Архивация (office and site) Цель: -Соблюсти все временные рамки
Весь период проекта- Communication….. With Sponsor/Project team Investigators Third parties SPC/Ethics …….
Team member turnover. Investigative site compliance. Cost of required supplies. Inflation/exchange rates. Sub-contractor performance. Ineffective communication. Changing sponsor requirements. Common Sources of Uncertainty or Risk in Projects Scope of Work complexity. Accuracy of estimates. False assumptions. Regulatory approvals. Difficult to recruit patient population. Use of new technologies. Team skill levels and productivity.