Contract Research and Development Organizations-Their History, Selection, and Utilization (PDF)
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· The history of CROs, including snapshots of CROs and a genealogy chart making clear where they came from and where they went.
· Study directors and principal investigators.
· The nuts and bolts of study performance.
· Electronic reporting requirements - SEND and eCTD (required for NDA, BLA, ANDA, and IND submissions).
· Consultants and their roles.
· An expanded examination of common problems and their solutions.
This book boasts complete directories to the global universe of operating labs - where they are, how to contact them, and what they do (including special capabilities). Additionally, checklists for qualifying labs and manufacturing facilities - and for auditing studies and projects at such facilities - are included. It is directed at those in industry (specifically directed at those working for companies using CRO services) but will also be of interest to scientists or administrators working in research organizations themselves.
In this case, the contents of this new work are essential to the target reader because the work, regulations, and actors (CROs) have evolved and changed at a rapid pace in the 10 years since the earlier volume that the author published. Likewise, the companies using these services have come to all be almost completely dependent on outsourcing. The earlier texts remain the only source of their kind (paper or electronic) on the field and the only noncommercial guide to the global industry and this volume provides a complete update.Dr. Spainhour has amassed approximately fifty years of experience in the pharmaceutical industry. For his first fifteen years Bart worked at a company known then as Smith Kline & French Laboratories and now as GlaxoSmithKline Corp., where he held positions in both the discovery and the development segments of the drug development process. Specifically, on the research side Dr. Spainhour's activities involved the areas of phosphodiesterase inhibition,
Dr. David Serota has over 43 years of experience as a toxicologist, with the first 40 years all in the preclinical contract research industry as both a senior scientist and as a senior leader. He has served as a Study Director on over 1000 studies involving most routes of compound administration in all common animal models and involving a large variety of clinical indications. He spent his first 15 years at Hazleton Laboratories in Vienna, Virginia where he served as a Senior Study Director and Director of Laboratory Operations. Moving to Southern Research Institute in Birmingham, Alabama in 1991 as Director of Toxicology, he left to join the staff of a new contract research organization, MPI Research in Mattawan, Michigan in 1997. During his 20 years there, he played a critical role in leading MPI Research to unprecedented success by becoming the third largest CRO in he world with the largest single site facility in the world (over one million square feet and approximately 600 animal rooms). He held numerous scientific and leadership roles there, retiring in 2016 as Senior Principal Study Director, Senior Vice President, and Director of Research. Following his retirement, Dr. Serota created an independent toxicology consulting company, 7th Inning Stretch Consulting LLC, which focuses on assisting companies in working with preclinical contract research organizations, including study designs and interpretations, and study monitoring. Dr. Serota received a B.S. in Pharmacy from Auburn University in 1969, a doctorate in toxicology from the University of Tennessee Center for the Health Sciences in 1976, and became a board-certified toxicologist in 1981, re-certifying every five years since. He is a 30+ year member of the Society of Toxicology and a 40-year member of the American College of Toxicology, where he served as President in 2012, and received the organization's Distinguished Service Award in 2015. Dr. Serota is considered an excellent public speaker and has presented a wide range of scientific topics at numerous forums. Over the years, Dr. Serota has remained engaged with numerous educational and philanthropic organizations and has contributed significantly to these organizations in terms of time and money. He currently serves on the Dean's Advisory Council at Auburn University's School of Pharmacy and on the local SPCA Board of Directors where he is a past president.
- Autoren: Shayne C. Gad , Charles B. Spainhour , David G. Serota
- 2020, 1st ed. 2020, 519 Seiten, Englisch
- Verlag: Springer-Verlag GmbH
- ISBN-10: 3030430731
- ISBN-13: 9783030430733
- Erscheinungsdatum: 17.07.2020
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- Dateiformat: PDF
- Größe: 6.02 MB
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