Data Science Institute-Industry-Innovation Seminar:Johnson & Johnson
Thursday,
November 21, 2019
11:00 AM - 12:30 PM
Online
Enhancing the Analyses of Data from Audits and Inspection of Clinical Trials to Enable Learnings and Drive Change
Abstract:
There are opportunities to enhance the analysis of data from audits and inspections of clinical trials to create learnings and change in the performance of clinical trials. These opportunities may be limited in the drugs and regulatory industry, due to the lack of suitably skilled personnel and analytics tools and methodologies. This session will include discussion of the following elements;
• Overview of current situation:
– types of audits and inspections performed in the pharmaceutical R&D environment
– data Analytics tools and methodologies
• What are some of the data analytics techniques by which we could optimize audit, inspection and clinical trial performance?
• What could the future be? Could we:
– delve deeper?
– give insights which guide actions?
– create more holistic views of findings and their outcomes?
– extend the data/sources analysed to give more holistic insights?
– be less focussed on looking back in time that we miss the looming risk areas?
– be more data driven in decisions?
– define what is truly a ‘signal’ versus ‘noise’ and prioritise those for action(s)?
Speaker:
Joanne North, Analytics Team Lead (Metrics, Analytics and Reporting)
Quality Analytics
BioResearch Quality and Compliance
Janssen R&D
Speaker Bio:
I joined Jannsen (part of the Johnson and Johnson group of companies) in September 2017, and lead a Data Analytics Team within BioResearch Quality and Compliance (a department which is involved in the conduct of audits of differing aspects of pharmaceutical activities, e.g. audits of clinical trial activities at hospitals). My team is responsible for a range of data analytics, including descriptive, predictive and prescriptive analytics on data from audits and inspections of clinical trials.
Previously I worked within the Clinical Quality Assurance team at GlaxoSmithKline R&D, where I set up and managed a Data Analytics function for 2 years, where I recruited and built the data analytics team and developed the analytics strategy.
I have several years experience in the conduct and management of audits and inspections of clinical trial related activities in GSK Pharmaceuticals, Vaccines and Consumer Healthcare businesses.
Abstract:
There are opportunities to enhance the analysis of data from audits and inspections of clinical trials to create learnings and change in the performance of clinical trials. These opportunities may be limited in the drugs and regulatory industry, due to the lack of suitably skilled personnel and analytics tools and methodologies. This session will include discussion of the following elements;
• Overview of current situation:
– types of audits and inspections performed in the pharmaceutical R&D environment
– data Analytics tools and methodologies
• What are some of the data analytics techniques by which we could optimize audit, inspection and clinical trial performance?
• What could the future be? Could we:
– delve deeper?
– give insights which guide actions?
– create more holistic views of findings and their outcomes?
– extend the data/sources analysed to give more holistic insights?
– be less focussed on looking back in time that we miss the looming risk areas?
– be more data driven in decisions?
– define what is truly a ‘signal’ versus ‘noise’ and prioritise those for action(s)?
Speaker:
Joanne North, Analytics Team Lead (Metrics, Analytics and Reporting)
Quality Analytics
BioResearch Quality and Compliance
Janssen R&D
Speaker Bio:
I joined Jannsen (part of the Johnson and Johnson group of companies) in September 2017, and lead a Data Analytics Team within BioResearch Quality and Compliance (a department which is involved in the conduct of audits of differing aspects of pharmaceutical activities, e.g. audits of clinical trial activities at hospitals). My team is responsible for a range of data analytics, including descriptive, predictive and prescriptive analytics on data from audits and inspections of clinical trials.
Previously I worked within the Clinical Quality Assurance team at GlaxoSmithKline R&D, where I set up and managed a Data Analytics function for 2 years, where I recruited and built the data analytics team and developed the analytics strategy.
I have several years experience in the conduct and management of audits and inspections of clinical trial related activities in GSK Pharmaceuticals, Vaccines and Consumer Healthcare businesses.
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