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Page 1: Impact of Food and Drug Administration’s (FDA) final guidelines for risk based monitoring on clinical trials | Beroe Webinar Presentation
Page 2: Impact of Food and Drug Administration’s (FDA) final guidelines for risk based monitoring on clinical trials | Beroe Webinar Presentation

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Page 3: Impact of Food and Drug Administration’s (FDA) final guidelines for risk based monitoring on clinical trials | Beroe Webinar Presentation

Panel Members:

Dr. Rajesh Jain Clinical Research Consultant Independent Consultant Dialing in from:

India

Moe Alsumidaie President & Chief Scientific Officer Annex Clinical Dialing in from:

USA

Ashwini Tripathi Senior Research Analyst Beroe Inc. Dialing in from:

India

Host

Panel Members for the Webinar

Sharan Ramesh Engagement Manager Beroe Inc. Dialing in from:

India

Moderator

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Page 4: Impact of Food and Drug Administration’s (FDA) final guidelines for risk based monitoring on clinical trials | Beroe Webinar Presentation
Page 5: Impact of Food and Drug Administration’s (FDA) final guidelines for risk based monitoring on clinical trials | Beroe Webinar Presentation
Page 6: Impact of Food and Drug Administration’s (FDA) final guidelines for risk based monitoring on clinical trials | Beroe Webinar Presentation
Page 7: Impact of Food and Drug Administration’s (FDA) final guidelines for risk based monitoring on clinical trials | Beroe Webinar Presentation
Page 8: Impact of Food and Drug Administration’s (FDA) final guidelines for risk based monitoring on clinical trials | Beroe Webinar Presentation
Page 9: Impact of Food and Drug Administration’s (FDA) final guidelines for risk based monitoring on clinical trials | Beroe Webinar Presentation
Page 10: Impact of Food and Drug Administration’s (FDA) final guidelines for risk based monitoring on clinical trials | Beroe Webinar Presentation

Release of Guidelines

Page 11: Impact of Food and Drug Administration’s (FDA) final guidelines for risk based monitoring on clinical trials | Beroe Webinar Presentation

15-25%

>35%

15-25%

Page 12: Impact of Food and Drug Administration’s (FDA) final guidelines for risk based monitoring on clinical trials | Beroe Webinar Presentation
Page 13: Impact of Food and Drug Administration’s (FDA) final guidelines for risk based monitoring on clinical trials | Beroe Webinar Presentation

CRAs will be enabled with analytical skills to identify problematic, missing

data before visiting a site.

41%

On site Monitoring

22%

Off site Monitoring

19%

Travel

13%

Administrative tasks

5%

Training

Page 14: Impact of Food and Drug Administration’s (FDA) final guidelines for risk based monitoring on clinical trials | Beroe Webinar Presentation
Page 15: Impact of Food and Drug Administration’s (FDA) final guidelines for risk based monitoring on clinical trials | Beroe Webinar Presentation
Page 16: Impact of Food and Drug Administration’s (FDA) final guidelines for risk based monitoring on clinical trials | Beroe Webinar Presentation

Lack of proven methodologies can impact the Engagement Model

between sponsor and the service providers

Page 17: Impact of Food and Drug Administration’s (FDA) final guidelines for risk based monitoring on clinical trials | Beroe Webinar Presentation

Source: CMR International Pharmaceutical R&D Factbook, 2012

Page 18: Impact of Food and Drug Administration’s (FDA) final guidelines for risk based monitoring on clinical trials | Beroe Webinar Presentation

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Page 21: Impact of Food and Drug Administration’s (FDA) final guidelines for risk based monitoring on clinical trials | Beroe Webinar Presentation

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