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Gavin Boodoo

Gavin Boodoo

Dr. Gavin Boodoo joined Quanticate in 2016 as The Manager of Remote Source Data Verification (rSDV) bringing more than 17 years of experience in clinical trials to the company. He leads Quanticate’s global rSDV group, providing leadership and support to group operations within the rSDV area. Prior to joining Quanticate Gavin held senior clinical project managerial positions in medium sized and large publicly traded companies within the pharmaceutical and CRO service industries.

Author's Posts

ICHGCP E6 Addendum R2 - What do you need to know?

Gavin Boodoo



The ICH Guidelines for Good Clinical Practice (E6) has morphed into the international standard for clinical trial conduct since its inception twenty years ago. However, within that period, clinical research has changed dramatically and it is a credit to it’s authors that ICHGCP remains relevant today, with only one previous notable update seen in response to electronic data capture (EDC) technologies being widely utilized by the industry. 

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Topics: Good Clinical Practice (GCP), FDA, Remote Monitoring, Quality Assurance, Data Transparency, Additional Monitoring, Technology Trends, Risk Based Monitoring, Centralized Monitoring, ICHGCP E6

The Evolution of Risk Based & Remote Monitoring

Gavin Boodoo

With a growing trend towards the use of risk based monitoring, and with new technologies available to support this alternative to traditional onsite monitoring, there remains inertia to implement this approach. Having discussed remote monitoring capabilities with industry peers, we have identified the root cause of this reluctance as an intrinsic fear of flouting regulatory compliance within the conduct of a clinical trial.

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Topics: Regulatory Requirements, Clinical Trials, FDA, Remote Monitoring, Remote Data Capture, Source Data Verification (SDV), On-Site Monitoring, Risk Based Monitoring, Centralized Monitoring

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