Clinical trials can be large complex projects that take years to complete, involve many different resources, and are covered by extensive federal regulations. The goal of all of this is to document the Efficacy of the treatment and to assure the safety of the patient.
This requires that the study be conducted according to a plan that assures that all of the resources are being used properly, within a schedule and within a budget and the safety and efficacy of the patient is assured.
Why Should You Attend:
In order to be in compliance with regulations and to maintain the Quality and Integrity of the information, the clinical trial must be managed properly.
Areas Covered in this Webinar:
Developing Plans for Projects (Studies)
Estimation of time and resources
Phases in a Clinical Trial
Phase I to Phase IV, Phase 0 and 5 Clinical Trials
List of Different Deliverables
Reporting and managing Progress
What is Project Management?
What are Clinical Trials?
How do I apply the Project Management tools to Manage Clinical Trials?
Who Will Benefit:
Clinical Research Staff
Richard Chamberlain is the President, Executive Consultant Services, LLC Consulting with numerous Pharmaceutical, Contract Research Organizations, and Medical Device companies in the areas of computerized project scheduling, strategic planning and Computer Systems Validation. Managed large-scale clinical projects including development and validation of Remote Data Entry systems, Adverse Event reporting, Drug Supplies, project planning and supervision of staffs. Taught numerous public and in-house courses on various aspects of Computer Systems Validation and Auditing Computer Systems. Assisted in the development and validation of numerous computerized systems in all GxP environments. Assisted with the development of all varieties of Standard Operating Procedures and other required documentation for compliance to regulations.
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