dh04 -manage tfls development in life science analytics
TRANSCRIPT
Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.
DH04 - Manage TFLs Development in Life Science Analytics Framework 5.3 using SAS and R code
Jean Marc Ferran, Stijn Rogiers
PHUSE US Connect 2021
Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.
Biography
DH04 - Manage TFLs Development in Life Science Analytics Framework 5.3 using SAS and R code
Stijn Rogiers• Pr. Industry Consultant in the SAS Global Health and Life Sciences Practice group• Joined SAS in 2015 providing industry expertise and strategic support.• 20 years of experience both at CRO and Pharma industry.• Member of the European CDISC Coordinating Committee (E3C).
Jean Marc Ferran• Principal Consultant & Owner at Qualiance• Helps customers implementing SCEs. Works with LSAF/SAS DD since 2005• 20 years of experience in the Life Sciences Industry• Appointed Member of the EMA Technical Anonymisation Group and Health Canada Reference
Group on Public Release of Clinical Information
Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.
Agenda
• The Business Case
• TLF module within SAS Life Science Analytics Framework 5.3
• Life Cycle Management Prototype
• Conclusion
Manage TFLs Development in Life Science Analytics Framework 5.3 using SAS and R code
Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.
Flow of activities
CreationReports
using APIs & Metadata
Conduct Programming & Validations
tasks
Kick OffStudy Level Workflows(UI or APIs)
Assignmentof Users, Level of
Validation, Workflows.
Re-Use TLF Metadata @Study Level
DefineGlobal TLF
Metadata & Workflows
Overview
Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.
Global - TLF Metadata
Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.
LSAF 5.3 and the TLF moduleGlobal TLF Metadata (1/3)
Configurable Global TLF Metadata
Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.
LSAF 5.3 and the TLF moduleGlobal TLF Metadata (2/3)
Configurable Global TLF Metadata
Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.
LSAF 5.3 and the TLF moduleGlobal TLF Metadata (3/3)
Configurable Global TLF Metadata
Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.
Incl. assignment of users/user groupsIncl. level of validation
Study Level - TLF Metadata
Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.
Life Cycle Management PrototypeDefine your Study-Level TLF Metadata (re-use from global/previous study) (1/3)
Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.
Life Cycle Management PrototypeDefine your Study-Level TLF Metadata (re-use from global/previous study) (2/3)
Programmer,Validator
and Reviewer Assignment
Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.
Life Cycle Management PrototypeDefine your Study-Level TLF Metadata (re-use from global/previous study) (3/3)
Level of Validation
Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.
Life Cycle Management PrototypeExport TLF Metadata using APIs
Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.
Study Level Workflows
Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.
Life Cycle Management PrototypeCreate Workflows for each Output using AutoFlow (or API) functionality
Development of workflows done in Eclipse(bpmn standard is required)
Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.
Life Cycle Management PrototypeCreate Workflows for each Output using AutoFlow (or API) functionality
Different Workflowfor each
Level of Validation
Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.
Life Cycle Management PrototypeAutomated actions triggered from e-Signature using Jobs within Workflow
Programs are automatically moved from Dev to Prod and Description (status) is updated
Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.
Life Cycle Management PrototypeWorkflow documents reason for changes after validation
Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.
Full traceability & reproducability
SAS & R programs integrated
Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.
Life Cycle Management PrototypeR programs and jobs can be integrated and follow same Life-Cycle Management
Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.
Life Cycle Management PrototypeR programs and jobs can be integrated and follow same Life-Cycle Management
Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.
Leveraging APIs and Metadata
Creation of Reports
Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.
Life Cycle Management PrototypeReporting using the APIs
Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.
Life Cycle Management PrototypeReporting using the APIs (Example code)
Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.
Conclusion
Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.
ConclusionManage TFLs Development in Life Science Analytics Framework 5.3
using SAS and R code
Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.
Conclusion
• TLF module can be used for planning purpose AND to capture outputs metadata.
ü TLF module can be configured
ü Export output metadata to a SAS dataset (using API or UI) to support the reporting of each TLF
Manage TFLs Development in Life Science Analytics Framework 5.3 using SAS and R code
Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.
Conclusion
• TLF module can be used for planning purpose AND to capture outputs metadata.
• It is possible to manage outputs supported by both SAS and R code
ü Integrated within SAS Life Science Analytics Framework; no need to work outside system for dev. nor execution
ü Traceability and Reproducability for both SAS and R programs
Manage TFLs Development in Life Science Analytics Framework 5.3 using SAS and R code
Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.
Conclusion
• TLF module can be used for planning purpose AND to capture outputs metadata.
• It is possible to manage outputs supported by both SAS and R code
• Setting up of Workflows can be automated using APIs and tailored to each company’s internal process
ü Workflow can be triggered on eSign activities & trigger next steps accordingly (e.g. move from DEV to PROD area)
ü It is possible to document after the validation state is reached any reason for change (e.g. change of specs)
Note: It is not possible to write back into the TFL module. Custom reporting is still required. Work in progress.
Manage TFLs Development in Life Science Analytics Framework 5.3 using SAS and R code
Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.
Documentation for your referenceLSAF APIs
https://support.sas.com/kb/65/943.htmlhttps://support.sas.com/kb/57/862.html
Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.
sas.com
Thank you for yourgreat contribution @
Ben Bocchicchio, Sandeep Juneja
Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.Copyr ight © SAS Inst i tute Inc . Al l r ights reserved.
sas.com
Any Questions ?
https://www.linkedin.com/in/jeanmarcferran/[email protected]
https://www.linkedin.com/in/stijnrogiers/[email protected]