Project Management of Clinical Trials

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Paul Naybour
Paul is a project management consultant and account manager with particular expertise in the analysis, process development, and implementation of change program management, risk management, earned value management, and bespoke project management training development and delivery. Paul is the Business Development Director of the company Parallel Project Training

I had an interesting trip to Barcelona last week to the PCMG (Pharmaceutical Contract Management Group) conference. They asked me to present of value management and who it has helped other sectors to improve cost performance on projects. It is really interesting to see the similarities between clinical research and other sectors. The sponsors who fund the project and the suppliers who run the trial do not collaborate during the feasibility stage of a project. Hence the Sponsor makes loads of assumptions. During a short tender stage there is insufficient time for the CRO to complete a proper feasibility study. Invariably the protocol for the project changes or fails to work in the most effective way. The result is delay and additional cost, disappointment and disillusionment of both sides.
There has to be a better way to plan and execute clinical trials projects. The focus must surely be on value and not cost. The trick is to find a way to bring the knowledge of the sponsor and the experience of the CRO to bear on the feasibility study. This has been done in other sectors, and has produced significant savings on cost. One approach would be to use to tools of value management to share the knowledge and experience. The next step is to work out how this can be implemented while maintaining a competitive environment.
Watch this space for a new clinical trials project management training course

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