The Selection and Use of Contract Research Organizations

ISBN-13: 9780415299039 / Angielski / Twarda / 2003 / 188 str.

Shayne Cox Gad;Shayne Gad

Opis

Choosing the right contract research organization (CRO) can make the difference between getting a product to market quickly and cost-effectively, and wasting valuable time and money. The myriad of CROs out there is increasing all the time, all making impressive claims. How do you pick the right one for your project? This guide for personnel in the pharmaceutical and medical device industries to making this important decision covers: guidance for selection, protocol and contract development, project management and monitoring of work; common pitfalls and problems - how to avoid them and how to solve them if they do occur; how to integrate efforts between groups to achieve the greatest cost effectiveness while maintaining quality and not losing time; prototype forms and templates for the use in the above process; and operative regulations and laws.

Recenzje

"[This book] is recommended for medical practices and libraries, and academic libraries with relevant programs of study or research areas."
- E-Streams, Vol. 7, No. 5, May 2004

Spis treści

IntroductionThe Pharmaceutical Development ProcessThe Medical Device Development ProcessFunctions and Types of CRO'sSelection of CROPricing and CostMonitoring WorkCommon Problems and their SolutionsAppendix Labs List Miscellaneous Labs and ServicesAnalytical LabsGMP Contract FacilitiesFormulationDosage FromClinical TestingRegulatory ServicesAudit Checklist

O autorze

Shayne C. Gad