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Impact of Food and Drug Administration’s (FDA) final guidelines for risk based monitoring on...

Date post: 03-Jul-2015
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Current clinical research methods allocate monitoring resources (primarily Clinical Research Associates (CRAs)) uniformly among the clinical trial sites. Through the use of existing and new technologies, risk-based monitoring is expected to allocate resources across clinical trials based on their level of risk while maintaining data quality and patient safety. This is expected to reduce the trial monitoring cost by 10-20%. We have also attached the Webinar video where Beroe’s Senior Research Analyst, Ashwini, discusses the Impact of FDA’s final guidelines for risk-based monitoring (RBM) on clinical research and role of suppliers/partners in this space with: Dr. Rajesh Jain – Independent Clinical Research Consultant Moe Alsumidaie - President & Chief Scientific Officer, Annex Clinical To know more about Beroe's Procurement intelligence services for Healthcare, contact us here http://www.beroeinc.com/contact (or) Email: [email protected]
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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

3

Page 4: Impact of Food and Drug Administration’s (FDA) final guidelines for risk based monitoring on clinical trials | Beroe Webinar Presentation
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Release of Guidelines

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15-25%

>35%

15-25%

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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
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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

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Low High

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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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