Outsourcing Clinical Research Projects
This book discusses the decision-making process of out-sourcing and provides a model of the process. It covers topics associated with finding an appropriate Clinical Research Organisation, including: the feasibility process, types of contracts, legal documentation and the working relationship between client and sub-contractor.
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Address Address Appendix approved in writing bid grid Chapter clinical research projects clinical trial COIN budgets competitive bid contract modifications CRO Pricing Model decision to outsource defined deliverables developing different CROs disclosing party example feasibility final protocol approved finance and project fixed price fixed unit price Fixed-price contracts important independent contractors investigator meetings documented involved Key Performance Indicators KPIs legal documents Liverpool Business School Mind Mapping number of investigator outsourcing decision outsourcing in clinical pass-through costs patients recruited payment schedule pharmaceutical company principal/agent problems project finance project management project progress Project Risk proposal receiving party recruitment rates relationship requirements resource risk analysis Risk Management Plan risks and opportunities Roger routine monitoring visit Scandinavia scope Scope creep select vendors sponsor stage stakeholders strategic outsourcing sub-contractor supplier tactical outsourcing tasks therapeutic experience travel and accommodation type of contract unit price contract variable contracts