Cook Clinical Studies Management

A Practical Guide to Success
1. Auflage 2004
ISBN: 978-1-135-49057-7
Verlag: CRC Press
Format: EPUB
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 128 Seiten

What if you were suddenly in charge? After the initial excitement of a "battlefield promotion" wears off, you need to get in the trenches and get the job done. And if you are already in the trenches, you need quick access to information that will make your job easier. A comprehensive desk reference and guide, Clinical Studies Management: A Practical Guide to Success provides the practical skills and methods required by project managers running clinical studies.

The author explains a framework for project management based on seven core themes: goals, budgets, time, resources, measurement, communication, and training. He solidly reviews how modern management theory can be brought to bear on the specialized demands of clinical trials. The book covers the practical how-tos of writing and costing a study, organizing an Investigator Meeting, and improving patient enrollment in your study. Divided into stand-alone chapters that make the information easy to find, the book presents a comprehensive overview of drug development processes and the trends that are driving change.

If you are new to study management, the book rapidly brings you up to speed. If you are an experienced study manager, it gives you a convenient and authoritative reference you will use on a daily basis. Whatever your level of experience, Clinical Studies Management: A Practical Guide to Success supplies the tools you need to manage your projects efficiently and effectively.

Zielgruppe

Pharmacological and CRO drug project managers, team leaders, CRAs, QA auditors, CRO business development staff, pharmacological and CRO drug development staff and trainers, physicians and clinical investigators, SMO staff, and drug development consultants

Autoren/Hrsg.

Cook, Simon

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie

Inhaltsverzeichnis

DRUG DEVELOPMENT AND INDUSTRY TRENDS
From Concept to Market
Industry Trends

CONTRACT RESEARCH ORGANIZATIONS
Outsourcing to CROs

THE ROLE OF THE CLINICAL STUDY PROJECT MANAGER
The Project Team
The Function of the Manager
High-Rise vs Hands-Off

GOALS AND STANDARDS
Objectives and Milestones
Clinical Research Standards
Writing a Study Protocol

BUDGETS
Where the Money Goes

TIME
The Cost of Time
Finding the Critical Path
The Proactive Approach

RESOURCES
Manpower
Drug Supplies

MEASUREMENT
Quality Tracking
Taking the Project Pulse

COMMUNICATIONS
Efficient Signalling
Team Meetings
Presentations

TRAINING
In Pursuit of Error-Free Work
Organizing an Investigators' Meeting

SURVIVING QUALITY ASSURANCE AUDITS
Quality Assurance in Clinical Research

TROUBLESHOOTING: A CASE HISTORY
Introduction
Problems
Prioritising Actions
Recruitment Enhancement
Getting Back on Track

CONCLUSIONS

References
Index