Re-engineering Clinical Trials: Best Practices for Streamlining the Development Process - Rilegato

Rilegato

ISBN 10: 0124202462 ISBN 13: 9780124202467

Casa editrice: Academic Pr, 2014

Riassunto

The pharmaceutical industry is currently operating under a business model that is not sustainable for the future. Given the high costs associated with drug development, there is a vital need to reform this process in order to provide safe and effective drugs while still securing a profit.  Re-Engineering Clinical Trials evaluates the trends and challenges associated with the current drug development process and presents solutions that integrate the use of modern communication technologies, innovations and novel enrichment designs. This book focuses on the need to simplify drug development and offers you well-established methodologies and best practices based on real-world experiences from expert authors across industry and academia. Written for all those involved in clinical research, development and clinical trial design, this book provides a unique and valuable resource for streamlining the process, containing costs and increasing drug safety and effectiveness.

• Highlights the latest paradigm-shifts and innovation advances in clinical research
• Offers easy-to-find best practice sections, lists of current literature and resources for further reading and useful solutions to day-to-day problems in current drug development
• Discusses important topics such as safety profiling, data mining, site monitoring, change management, increasing development costs, key performance indicators and much more

Su questo libro

Recensione

"...a good overview of problems facing the pharmaceutical industry in the design and conduct of clinical trials, especially within the current regulatory framework. Score: 74 - 3 Stars" --Doody's

L'autore

Peter Schüler is Senior Vice President, Global Medical & Safety Services, ICON Plc. Peter is board certified in neurology (1996; German Medical Board) and in Pharmaceutical Medicine (2001; Swiss Medical Association). In 1999 in obtained a Certificate in Business Administration by Henley Management College, UK. After his medical education he started is professional career in 1987 at the Medical Imaging Application Center of Siemens AG Medical Solutions. The same year he started at the Department of Experimental Neuropsychiatry of the Neurological University Hospital Erlangen, Germany. During the coming 8 years he was involved in basic and clinical CNS research. He held the position of Secretary General of the German section of the International League Against Epilepsy (ILAE; 1991-1995) and was awarded two scientific awards (Alfred-Hauptman epilepsy prize and ILAE Young Investigator Award). In 1995 he joined Pharmacia. During that period, he participated in the launch of two NCEs in the indications Parkinson’s and major depression. In October 2000 he moved into the CRO business, building a department for Medical Affairs and also taking over responsibilities for clinical operations in Germany, Austria and Switzerland. In 2007, Peter joined ICON, now overseeing over 360 people located in 11 major offices in Argentina, Brazil, Germany, India, Japan, Latvia, Mexico, Poland, Singapore, UK and US. He issued several publications on drug safety and authored an eBook about clinical trial design and conduct (Zenosis Ltd publisher) and continues to lecture Pharmaceutical Medicine at the Universities of Duisburg-Essen, Germany and Aveiro, Portugal.

Dettagli dell?edizione

• Editore: Academic Pr
• Data di pubblicazione: 2014
• ISBN 10: 0124202462
• ISBN 13: 9780124202467
• Rilegatura: Copertina rigida
• Lingua: Inglese
• Numero edizione: 1
• Numero di pagine: 360
• Redattore: Schueler Peter, Buckley Brendan