Infosys Benefit Risk Assessment · learning (ML), arti˜cial intelligence (AI) and natural language...
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Conclusion and Dissemination: Communicate results, gain consensus, provide an audit trail of the assessment process Planning: Understand critical issues related to a particular BRA, including the purpose and context of the assessment Exploration: Validate results with assumptions and uncertainties; consider impact or added value of risk minimization measures Evidence gathering and data preparation: Identify data sources; extract evidence relevant to the BRA using NLP, Classification, Deep Learning like SVM, Neural Networks, etc. Analysis: Data evaluation, data analysis using frameworks and algorithms such as BRAT, PrOACT-URL, ITC, MCDA, SMAA, etc., that are relevant to BRA; quantifying the magnitudes of benefits and risks and applying weightages. Visualize the analysis outcome through industry standard tools such as Tableau/ R-Shiny or create complex visualizations using Javascript libraries Key Solution Attributes/Tenets Decision-making with regard to the benefits and risks of drugs is fundamental and is often complex for both experimen- tal and marketed drugs. Current benefit risk analysis approaches are human effort intensive, taking up about a third of overall safety and medical affairs operations efforts. With the advancement in data analysis techniques using machine learning (ML), artificial intelligence (AI) and natural language processing (NLP), there is an opportunity to gain efficien- cies while successfully and continuously monitoring the benefit risk profile of medicines. The platform helps biostatisticians, epidemiologists, patient safety personnel and regulatory stakeholders to compre- hensively evaluate and monitor benefit risk profile of their drug through clinical development and post-marketing stages; it also helps in assessing the benefit risk profile of the drugs vis-à-vis those from competitors. Infosys is working towards automating the Benefit Risk Assessment (BRA) process using frameworks such as PROTECT http://protectbenefitrisk.eu/ to provide an integrated view across the 5 stages of benefit risk assessment roadmap. Outcomes External Document © 2017 Infosys Limited Infosys.com Industry Need BENEFIT RISK ASSESSMENT
Transcript of Infosys Benefit Risk Assessment · learning (ML), arti˜cial intelligence (AI) and natural language...
Conclusion and Dissemination: Communicate results, gain
consensus, provide an audit trail of the assessment process
Planning: Understand critical issues related to a particular BRA, including
the purpose and context of the assessment
Exploration: Validate results with assumptions and uncertainties; consider
impact or added value of risk minimization measures
Evidence gathering and data preparation: Identify data
sources; extract evidence relevant to the BRA using NLP,
Classi�cation, Deep Learning like SVM, Neural Networks, etc.
Analysis: Data evaluation, data analysis using frameworks and
algorithms such as BRAT, PrOACT-URL, ITC, MCDA, SMAA, etc., that are
relevant to BRA; quantifying the magnitudes of bene�ts and risks and
applying weightages. Visualize the analysis outcome through industry
standard tools such as Tableau/ R-Shiny or create complex
visualizations using Javascript libraries
Key Solution Attributes/Tenets
Decision-making with regard to the bene�ts and risks of drugs is fundamental and is often complex for both experimen-tal and marketed drugs. Current bene�t risk analysis approaches are human e�ort intensive, taking up about a third of overall safety and medical a�airs operations e�orts. With the advancement in data analysis techniques using machine learning (ML), arti�cial intelligence (AI) and natural language processing (NLP), there is an opportunity to gain e�cien-cies while successfully and continuously monitoring the bene�t risk pro�le of medicines.
The platform helps biostatisticians, epidemiologists, patient safety personnel and regulatory stakeholders to compre-hensively evaluate and monitor bene�t risk pro�le of their drug through clinical development and post-marketing stages; it also helps in assessing the bene�t risk pro�le of the drugs vis-à-vis those from competitors.
Infosys is working towards automating the Bene�t Risk Assessment (BRA) process using frameworks such as PROTECT http://protectbene�trisk.eu/ to provide an integrated view across the 5 stages of bene�t risk assessment roadmap.
Outcomes
External Document © 2017 Infosys Limited Infosys.com
Industry Need
BENEFIT RISK ASSESSMENT
