outsourcing send conversions a case study · standard for exchange of non-clinical data (send) data...
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Outsourcing SEND ConversionsA Case Study
April 10th, 2018
Joanne Tyas MRQA, RQAP-GLP
Director Quality Assurance
ITR Laboratories Canada Inc.
Vince D'Angelo FRQA
VP Global Quality Assurance
Instem
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Standard for Exchange of Non-clinical Data (SEND)
Data standard developed
by CDISC - Clinical Data
Interchange Standards
Consortium
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Standard for Exchange of Non-clinical Data (SEND)
Specifies a way to
present non-clinical data in
a standard way
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Standard for Exchange of Non-clinical Data (SEND)
Required by FDA as part
of a submission for drug
approval
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Benefits of SEND in the Drug Approval Process
Efficient
Faster
Improved Data Review & Analysis
Create Data Warehouses
Data Mining and Analysis
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Converting Non-Clinical Data to SEND Format
CRO Sponsor FDA
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Factors Influencing the Decision to Outsource
Tools & Resources for
Conversion
Knowledge &
Expertise of SEND
Time
Cost
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Why ITR Selected Instem as the Service Provider
Previous
experience of
working with
Instem
➢ Provantis ®
Solution for the
conversion
process
➢ SubmitTM
Reputation ISO9001:2015
accredited
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Key Dependencies
Data Integrity Data Security
Privacy
Expertise &
Knowledge
Quality Timeliness
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Qualification Process
Request for
Information
Desktop Audit
Remote Audit
➢ Instem personnel
➢ Processes and procedures
➢ Review of documentation
Conducted a Pilot
Conversion Study
➢ ITR’s study data
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Pilot SEND Conversion Study
Responsibilities
Data Management Standard Operating
Procedure
Resources
Timelines
Service Agreements
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Quality Considerations
Quality Control
Quality Assurance
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Key Area Identified
Data hosted in a data warehouse owned by a third party
Evaluate controls in place to mitigate risks
Risk Mitigation
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Going Live
First Commercial
Conversion
November 2017
Several Conversions Since
Increase in Demand
Continue to Assess Services
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Lessons Learned
Collaboration Is Key
Pilot Study a
Valuable Exercise
Must Be Adaptable
Not to Underestimate CRO
Time and Resources
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Future
Continue to Review &
Improve Process
Collect data in a SEND
Compliant Manner
Automate Data CaptureSEND Files a Valuable Tool
➢ Study Data Evaluation &
Interpretation
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Is Your Team SEND Ready?
Questions?
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