Short presentation describing the key points of project planning and PMO basics.

1. Project Planning & Resource ManagementAn Introduction by Adrian Leibert

2. Why Plan? Answer: To deliver the desired outcome On Time and On Budget Statistics show that project overrun (in terms of both cost and time) remains a real issue across many industries. Average overrun within the IT sector is estimated to be 24% on original baselined schedule and budget.* By deploying the techniques of a strong Project Management Office the average project will save circa 12-19% of the original project budget. *Source: A Study in Project Failure (2008), Dr John McManus and Dr Trevor Wood-Harper According to Gartner, world-class organisations enjoy an IT project success rate close to 90 percent. These same organisations have also invested in project planning & resource management and are reaping the benefits.

3. Good project planning has a focus on information management I.e. ASSEMBLE ANALYSE DESSEMINATE For communication: so we understand interdependencies and timelines and we know what other people are doing. For success: So we all work to the same agreed objectives, using our total resources most effectively. For continuous improvement: so we share knowledge and experience, to provide consistency, a central repository of project information.

4. An accurate project plan will concentrate effort on those “critical” tasks that are rate limiting to program delivery Decide on Formulation and device Machine fill 13 wks Validate GMP equipment 2 mo Manufacture and release clinical supplies 2.5 mo Pack clinical Supplies 1 mo Set down on stability for CTA Develop Analytical Methods 3 mo T=1 mo stability data 20d 3 mo CTA and Ethics Approval Submit CTA and Ethics Obtain Device Parts 6 wks Testing and verification. of device 4 mo Supplies on site First Subject First Visit 8 months

5. Risks should be actively identified & managed and contingency built into project plans Risk Management Risk Grading Impurity levels too high or not matching reference Clinical approach not acceptable H Phase III study doesn’t show equivalence Device malfunction during trial Study fails to show equivalence Severity Low manufacturing yield M Delay to release of medical device impacts clinical timelines Shelf life not sufficient for clinical trials L H M L

6. Forecasting allows for advance warning of peaks and troughs and therefore: Movement of staff from project to project. Prioritisation of tasks Recruitment Planning for New Projects As resource forecasting is improved, costs and timelines for new projects will be improved. There will be less variation between ‘predicted’ and ‘actual’ resource requirements. Good project planning should be in combination with good resource forecasting

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