Managing Clinical Trials

Event Information
Product Format
Prerecorded Event
90 Minutes
Product Description

Does Your Staff Conduct a Compliant Clinical Trial?

This is the first in a series of training sessions intended to understand the essence of a managed clinical trial. Now, one way for hospitals, clinics and CROs to increase revenues is to do more clinical trials. In order to do this they must prepare their staffs to be ready to do clinical trials.

This is a 90 minute enlightening session that anyone in a hospital, clinic or CRO who might be involved in conducting a clinical trial should take. If they have never been involved they will learn what one is, if they have done clinical trials it will be useful to put everyone on the same level as far as terms and operations. The session will take them through the things to watch for that will need attention during the trial. They will see the different aspects that need to be managed.

Here's a look at what Richard will cover:

  • What is a Clinical Trial? What to watch for, size - large vs small, managing the trial – people, schedule and follow the protocol
  • The Study: Planning, costs, execution, completion and other things
  • Insights on how to manage large trials
  • What makes up a Clinical Trial? – Subjects, sites, length of trial, collect/observe subject values
  • What difference does size make & what to do about it
  • Detailed project template
  • Potential Issues: Enrollment, computer/data collection, central lab(s), drug supply, equipment
  • Enrollment: IRB approval, site enrollment, subject enrollment, training review, review site procedures and is drug, data entry, equipment available and working?
  • Planning – Computer, central labs, drug supplies
  • Other Issues :
    1. 1. Are all "Required" analyses complete?
    2. 2. Sponsor has a regulatory requirement to perform analyses that could benefit the Subjects in the trial, even if the results had no “revenue” interest for the company.
    3. 3. Were "extra" samples taken – e.g. genetic samples? Many companies now take Genetic samples for “further” analyses.
    4. 4. There are a variety of legal and ethical questions surrounding the analysis of these samples and these change
    5. 5. Were Sub-studies Performed?
    6. 6. Was the extra data managed properly?
    7. 7. Were the analyses performed properly?
    8. 8. When and where will the results be published?
  • And much more…

Who should attend? Nursing staff, Physicians, Clinical Pharmacists, Lab Technicians, Finance/Accounting, IT, Marketing personnel, Clinical Research Associates, Biometric Specialists, Data Managers, Medical Writers, Regulatory Affairs Specialist, Statisticians and Contracting Professionals

Order Below or Call 1-866-458-2965 Today

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About Our Speaker

Dr. Richard Chamberlain - Pharma Compliance Expert

Dr. Richard Chamberlain has provided executive consulting services to numerous Pharmaceutical, Biotechnical, Medical Device companies, and international Contract Research Organizations in the areas of strategic planning project management for the development of computerized project management tools and Computer Systems Validation.

managed large-scale clinical projects from the project planning phase until project closure. He has taught numerous public and in-house courses on various topics such as: Computer Systems...   More Info
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