Contract Research and Development Organizations-Their History, Selection, and Utilization

This book provides a comprehensive update of previous volumes on CROs, including history, study directors, principal investigators, electronic reporting requirements, consultants, and common problems and solutions. It includes directories to testing labs and other support establishments worldwide and checklists for qualifying labs and manufacturing facilities. It is directed at those in industry and research organizations, as the industry, regulations, and actors have evolved and changed rapidly in the past 10 years.

Format: Paperback / softback
Length: 519 pages
Publication date: 18 July 2021
Publisher: Springer Nature Switzerland AG

This comprehensive volume offers a thorough update of all the materials covered in previous volumes on the subject, encompassing current directories to testing labs and other support establishments worldwide. Additionally, it includes substantial new content on various topics, such as:

A historical overview of CROs, including snapshots of CROs and a genealogy chart that elucidates their origins and evolution.

An in-depth exploration of study directors and principal investigators, their roles, and responsibilities.

A detailed account of the intricacies involved in conducting studies, including key performance indicators and electronic reporting requirements (such as SEND and eCTD, which are essential for NDA, BLA, ANDA, and IND submissions).

An expanded examination of consultants and their crucial roles in research projects.

A comprehensive analysis of common problems and their effective solutions.

In addition to providing comprehensive directories to testing labs and support establishments worldwide, this book includes checklists for qualifying labs and manufacturing facilities, as well as for auditing studies and projects at such facilities. It is specifically designed for individuals in the industry, particularly those working for companies utilizing CRO services. However, scientists and administrators in research organizations will also find this volume invaluable due to the rapid evolution and changes in the field, regulations, and actors (CROs) over the past decade.

Given the significant reliance of companies on outsourcing services, the contents of this new work are of utmost importance to the target audience. While earlier texts remain the sole source of their kind (paper or electronic) on the subject, this volume serves as a complete update, ensuring that readers remain well-informed and up-to-date with the global industry.

Weight: 694g
Dimension: 210 x 148 (mm)
ISBN-13: 9783030430757
Edition number: 1st ed. 2020