That's a quite a shock to hear…surprisingly a lot of companies fail to define its core competencies and follow jump into outsourcing bandwagon quite bluntly. Anne Maria Ylisaari, head of In- and Outsourcing feels functions like trial planning, design and writing of the outline, designing the case report forms (CRF), writing the monitoring plan and statistics should be done in house. She feels that functions like protocol writing, feasibility study, printing of CRFs (case report forms) and consultancy on the protocol design, regulatory submissions and recruitment plan should be outsourced. She has given some more suggestions on this. You can get it here. Must say, quite a comprehensive guide for all the pharmaceutical managers.
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