Implementation, Evolution and Change Management Required for Remote Source Data Verification (rSDV)

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Webinar Details

Duration: 60 minutes
Speaker: Dr. Gavin H.R Boodoo, Remote Clinical Data Monitoring (RCDM) Manager, Quanticate

In this webinar, you will learn how implementation, evolution and change management are critical for a successful remote monitoring program. But how does a remote monitoring program harmonize with current Source Data Verification practices?

Remote Source Data Verification (rSDV) is a well-­defined task within our industry by Sponsors, vendors and sites, but is a relatively new practice that due to its infancy has a multitude of definitions and applications. The practices proposed, explored and piloted, range from reviewing fax transmitted source documents to video recording and archiving patient visits. The term remote Source Data Verification needs to be both defined and standardized across the industry to create a common and targeted dialog that explores the impact of different practices and technologies on both cost and achievable data integrity. 

Key Areas included in this webinar:

  • Innate weaknesses of on-site monitoring
  • Advantages of remote monitoring/rSDV
    • Increased accuracy
    • Reduced time to submission
    • More focus to enhance CRA activities
    • Cost savings
    • Improved recruitment
  • Internal change management required
  • Advantages of rSDV to fulfil ICH E6 addendum
  • New Job functions required

 

About Our Speaker 

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Dr. Gavin H.R Boodoo, Remote Clinical Data Monitoring (RCDM) Manager, Quanticate


Dr. Gavin Boodoo joined Quanticate in 2016 as Remote Clinical Data Monitoring (RCDM) Manager 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.

    

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