Training Course on Essentials of Clinical Study Management
Venue: Marriott Rive Gauche Hotel
|Event Date/Time: Nov 02, 2011||End Date/Time: Nov 04, 2011|
Featuring an esteemed European training faculty with over 100 years of combined experience in phase I-IV clinical trial management at big pharma, biotechnology firms, CROs and SMEs, as well as academic clinical research centres.
The success of a clinical study is very much dependant on its efficient preparation and effective conduct. Study managers should be knowledgeable about required quality and regulatory standards, roles and responsibilities of team members, and be able to select and oversee internal and external resources. Study managers also should be able to anticipate potential problems offer creative solutions and develop strategies to mitigate risk.
This training course provides a comprehensive overview of the essential elements of study management and the clinical study environment in the context of the overall drug development process. After successful completion of the training course, the participants will be able to plan, execute and manage a clinical study from protocol to final report.
Drug Development Process
Quality Management System
Essentials of Site Management
Investigational Product Handling
Risk Management & Safety Reporting
Study Evaluation & Reporting
This course will provide proven strategies for preparing, launching and managing a clinical study from protocol to final report.
At the conclusion of this course, participants should be able to:
Describe the role of the study manager in reaching the study objectives.
Explain clinical research phases in drug development and describe basic concepts of study design.
Explain the regulatory framework in which studies are conducted and how compliance with the applicable regulations is achieved.
Identify the activities involved in study planning and start-up, including feasibility and budgeting.
Qualify, select and oversee vendors and external resources for the study.
Identify various types of clinical trial communication plans.
Describe the data management and statistical evaluation process and be able to manage the final study report preparation.
Recognise European safety reporting requirements.
Describe the quality management system.
Discuss risk management and contingency planning.
Junior/Intermediate Level Clinical Research Professionals.
This course will particularly benefit those newly appointed to, or interacting with, a clinical study management position, e.g. clinical research professionals with some basic experience in the field of clinical research, who need a broader understanding of the principles of clinical study management. This course will also benefit study managers in an academic research setting who interface with industry.