impact of food and drug administration’s (fda) final guidelines for risk based monitoring on...
DESCRIPTION
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]TRANSCRIPT
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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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Release of Guidelines
15-25%
>35%
15-25%
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
Lack of proven methodologies can impact the Engagement Model
between sponsor and the service providers
Source: CMR International Pharmaceutical R&D Factbook, 2012
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TransCelerate
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