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Choosing the right contract research organization (CRO) can make the difference between getting a drug or medical device to market quickly and cost-effectively and wasting valuable time and money. This book provides guidelines for selection, protocol, and contract development; discusses project management and monitoring of work; explores how to integrate efforts between groups to achieve the greatest cost effectiveness while maintaining quality and not losing time; and includes prototype forms and templates for use in the above processes. It covers common pitfalls, how to avoid them, and how to solve them if they do occur. The appendices contain contact information for hundreds of prominent service providers.
Introduction. The Pharmaceutical Development Process. The Medical Device Development Process. Functions and Types of CRO's. Selection of CRO. Pricing and Cost. Monitoring Work. Common Problems and their Solutions.
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