Product-based planning: the importance of project and project management deliverables in the management of clinical trials

Authors: Bryde, David James¹; Joby, Roger²

Source: R&D Management, Volume 37, Number 4, September 2007 , pp. 363-377(15)

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Abstract:

As the cost of clinical trials continues to rise organisations are looking at ways of managing this part of the drug development process as effectively and efficiently as possible. As a tactical response, many pharmaceutical companies outsource the management of clinical trials to clinical research organisations on a fixed-price contract basis. This paper presents an alternative approach based on the concept of Product-Based Planning. Key elements of the approach are the creation of a deliverables budget and the establishment of project management-related deliverables. The conceptual developments described in the paper are supported by a telephone survey of 10 UK practitioners. The survey confirms the prevalence and limitations of fixed-price contracts while highlighting a willingness to try a deliverable-based approach - initially through small pilot studies. The key barrier to implementing a new approach is resistance from key stakeholders, such as finance departments, which can be addressed through selling of the business case.

Document Type: Research article

DOI: http://dx.doi.org/10.1111/j.1467-9310.2007.00482.x

Affiliations: 1: Reader in Operations Management, Liverpool Business School, Faculty of Business and Law, Liverpool JM University, John Foster Building, 98 Mount Pleasant, Liverpool L3 5UZ, UK., Email: D.J.Bryde@livjm.ac.uk 2: Principal Consultant, 1to1to1, 34 Romans Gate, Pamber Heath, Hants RG26 3EH, UK., Email: roger.joby@btinternet.com

Publication date: 2007-09-01