IDEO Interactive DEcision Oncology Phuse EU Connect 2020 - DV05 - IDEO Charlotte Cheinin Programming Project Leader [email protected]
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IDEOInteractive DEcision Oncology
Phuse EU Connect 2020 - DV05 - IDEO
Charlotte CheininProgramming Project [email protected]
•Clinical decision context• Initiative•Data flow•Demonstration
Agenda
Phuse EU Connect 2020 - DV05 - IDEO
Phuse EU Connect 2020 - DV05 - IDEO
• Complex data• Various sources• Multiple stakeholders• Sequential steps
Complex
Phuse EU Connect 2020 - DV05 - IDEO
• Complex data• Various sources• Multiple stakeholders• Sequential steps
Complex
• Fixed database• Static Tables/Figures/Listings
Decision
Phuse EU Connect 2020 - DV05 - IDEO
• Complex data• Various sources• Multiple stakeholders• Sequential steps
Complex
• Data availability & decision: weeks/months• Years from early development to
market
Time
• Fixed database• Static Tables/Figures/Listings
Decision
Ø Accelerate decision making process in oncology
Biostatistics & Programming initiative
Phuse EU Connect 2020 - DV05 - IDEO
Ø Accelerate decision making process in oncology
• Faster statistical deliveries• Interactive• Quality-control• Regulatory & standards
Biostatistics & Programming initiative
Phuse EU Connect 2020 - DV05 - IDEO
Ø Accelerate decision making process in oncology
• Faster statistical deliveries• Interactive• Quality-control• Regulatory & standards
• Focus• Early oncology• Efficacy (RECIST)• Safety (lab, AEs)
Biostatistics & Programming initiative
Phuse EU Connect 2020 - DV05 - IDEO
IDEO
IDEO in the Sanofi Data Flow
Phuse EU Connect 2020 - DV05 - IDEO
SourceRaw Data
eCRFdata
External Data
STDM hybrids
Data
Bridge
IDEO
Statistical Programmer
Phuse EU Connect 2020 - DV05 - IDEO
SourceRaw Data
eCRFdata
External Data
STDM hybrids
Data
Bridge
IDEO
Statistical Programmer
OutsourcedSTDMs
OR
IDEO in the Sanofi Data Flow
Phuse EU Connect 2020 - DV05 - IDEO
SourceRaw Data
eCRFdata
External Data
SDTMs* ADaMs*STDM hybrids
Data
Bridge
Statistical Programmer
SAS
OutsourcedSTDMs
OR
IDEO
IDEO in the Sanofi Data Flow
Phuse EU Connect 2020 - DV05 - IDEO
SourceRaw Data
eCRFdata
External Data
SDTMs* ADaMs*STDM hybrids
Data
Bridge
IDEO
Statistical Programmer
RShiny
SAS
* Using minimal prerequired variables following CDISC & Sanofi oncology standards
OutsourcedSTDMs
OR
IDEO in the Sanofi Data Flow
IDEOInteractive
DEcisionOncology
Phuse EU Connect 2020 - DV05 - IDEO
DEMO
Phuse EU Connect 2020 - DV05 - IDEO
• RShiny• Interactive statistics• User-friendly
• SDTM/ADaM• Standards• Minimal prerequisites
• Quality
• User access control• Regulatory
IDEOInteractive
DEcisionOncology
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