The last 10 years have seen a seismic shift in therapeutic product development and testing. In both the pharmaceutical (both small and large molecule) and medical device sectors, the vast majority of testing and evaluation of products is not performed within innovator companies, but rather has been outsourced to a growing universe of commercial organizations. The authors both have more than 30 years experience in this field, and both have worked within innovator companies, for CROs, and as consultants in the field. Contract Research and Development Organizations: Their Role in Global Product Development has been crafted by these authors to provide a how to guide for all aspects of working with CROs in selecting, working with and ensuring the best possible desirable outcome of having the R&D function, or substantial parts of it, outsourced. It uses as the exemplary case nonclinical safety assessment, biocompatibility and efficacy testing which are to be performed to select the best possible candidate compound, device or formulation and then moving the resulting regulated therapeutic medical product into and through the development process and to marketing approval. But also covered are the contract synthesis of drug substances and corresponding manufacture of biologics and manufacture of products, formulation development, clinical evaluation, regulatory and document preparation support, and use of consultants. Included in the volume are an exhaustive listing of those CROs in the (drug and device) safety evaluation sector and their contact information and capabilities, and extensive similar listing for the other types of contract service providers. Also included are guidances on how to monitor ongoing work at contract facilities and audit check lists for GLP, GMP and GCP facilities. These listings are international in scope, and a specific chapter addresses working with some of the newer international CROs.

‘Making It’ as a Contract Researcher examines the contemporary experience of research employment in universities from the perspective of a significant yet often invisible group: temporary or contract researchers, who make up a substantial, and ever-growing, proportion of the academic research workforce. A critical, pragmatic and international account of the contemporary research career, this book explores the question of what it means to ‘make it’ as a contract researcher in academia, and how individuals and organisations in higher education might seek to do things differently. Providing the reader with practical and realistic strategies for improving the experience of being a contract researcher and achieving and sustaining an academic research career, this book guides the reader on a range of topics, including: Charging fairly for your work Building a publication track record Finding the next contract Sustaining your network Feeling like you belong Moving beyond contract research. Using a combination of current research, interviews and reflective writing, the book is written specifically for and by contract researchers in academia, offering unique and extremely valuable advice for all new and current contract researchers, including PhD students, early career researchers, and any party interested in pursuing a research career in academia. The ‘Insider Guides to Success in Academia’ offers support and practical advice to doctoral students and early-career researchers. Covering the topics that really matter, but which often get overlooked, this indispensable series provides practical and realistic guidance to address many of the needs and challenges of trying to operate, and remain, in academia. These neat pocket guides fill specific and significant gaps in current literature. Each book offers insider perspectives on the often implicit rules of the game – the things you need to know but usually aren’t told by institutional postgraduate support, researcher development units, or supervisors – and will address a practical topic that is key to career progression. They are essential reading for doctoral students, early-career researchers, supervisors, mentors, or anyone looking to launch or maintain their career in academia.