What is the value of a comprehensive and detailed literature review? Once all the articles are collected, how do you analyze the information in manageable pieces? How do you assess the quality of the information you have collected? How do you summarize the findings to ensure you have represented both the positives and negatives? Then how do you incorporate this information into your clinical study report?

Whether it is for a device, drug or food product, there is immense benefit to be had from conducting a strategic literature search. However, it can be a huge undertaking, dependent upon the subject matter and the information publically available. It can feel like an overwhelming demand on time with very little return, when, in fact, in many cases it is quite the opposite.

This presentation takes a step-by-step approach to conducting a well-designed literature review, looks at how to translate the findings into a clinical evidence report that has scientific merit, and also how this information can be used in your clinical study report. Our speaker also discusses when the review and reports should be completed to aid your product development/stage gate or claim substantiation process, and how creating standard procedures in your clinical quality systems to outline the required steps can be an immense aid.

This audio conference covers:

• How to conduct a comprehensive and detailed literature search
• Methods to evaluation of the literature acquired
• Development of a scientifically valid clinical evidence report
• Incorporating the evidence into clinical study reports
• When it is most beneficial to conduct the review
• How to include the process in your clinical quality systems

About the speaker:

Joy Frestedt, PhD, RAC, CCTI is President & CEO of Frestedt Incorporated, a novel virtual network with 50 experts meeting client needs in regulatory, clinical and quality affairs. Dr. Frestedt has 30 years of scientific, clinical and regulatory experience in the health care, pharmaceutical, medical device and food industries including work at University of Minnesota, Mayo Clinical Trial Services, Johnson and Johnson, AstraZeneca, Orphan Medical, CNS Therapeutics, Medtronic and others. Dr. Frestedt holds a Ph.D. in pathobiology from the University of Minnesota Medical School and she is a member of ASCO, AAPS, ACRP and she currently Chairs the Ethics Committee for the Regulatory Affairs Professionals Society.

Who should attend?

• Directors of Clinical Affairs
• VPs & Directors of Regulatory Affairs
• Manager of Quality Systems
• VPs, Vigilance and Safety Reporting
• Clinical Research Coordinators & Associates
• Document Administrators
• Corporate Librarians