{"title":"Product-Based Planning: The Importance of Project and Project Management Deliverables in the Management of Clinical Trials","authors":"D. Bryde, R. Joby","doi":"10.1111/j.1467-9310.2007.00482.x","DOIUrl":"https://doi.org/10.1111/j.1467-9310.2007.00482.x","url":null,"abstract":"As the cost of clinical trials continues to rise organizations 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 organizations 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.","PeriodicalId":408154,"journal":{"name":"BioRN: Clinical Pharmacology (Topic)","volume":"68 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2007-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114265382","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}