Niamh McGuinness
Senior Manager of Clinical Trial Transparency and Privacy
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The Future of Clinical Document Submissions
In this session, we discuss the three strategies you need to consider when planning your approach to submitting clinical trial documents in 2021.
As privacy concerns continue to make headlines in the pharmaceutical space, sponsors face growing pressure to meet ever stricter regulatory requirements to anonymize clinical trial document submissions. To stay resilient, your organization must employ an approach that shields it from further regulatory shifts.
Featured Topics:
Learning Objectives:
Presenters
Niamh McGuinness, BPharm, PHD, Senior Analyst, Clinical Trial Transparency, Privacy Analytics
Lukasz Kniola, Principal Analyst – Data Sharing, Biogen
Sabrina Brown, Expert Transparency Manager, Novartis Pharmaceuticals Corporation
In this session, we discuss the three strategies you need to consider when planning your approach to submitting clinical trial documents in 2021.
As privacy concerns continue to make headlines in the pharmaceutical space, sponsors face growing pressure to meet ever stricter regulatory requirements to anonymize clinical trial document submissions. To stay resilient, your organization must employ an approach that shields it from further regulatory shifts.
Featured Topics:
Learning Objectives:
Presenters
Niamh McGuinness, PhD, Senior Analyst, Clinical Trial Transparency, Privacy Analytics
Lukasz Kniola, Principal Analyst – Data Sharing, Biogen
Sabrina Brown, Expert Transparency Manager, Novartis Pharmaceuticals Corporation
Niamh McGuinness is a technical lead with Privacy Analytics’ Clinical Trial Transparency (CTT) business unit. Her team works with a variety of clinical trial sponsors that have turned to us to meet the stringent requirements of regulations such as EMA Policy 0070 and Health Canada Public Release of Clinical Information (PRCI). Drawing on her academic research background, Niamh has helped develop Privacy Analytics’ CTT methodology and our proprietary toolsets.
Niamh McGuinness
Senior Manager of Clinical Trial Transparency and Privacy
Situation: California’s Consumer Privacy Act inspired Comcast to evolve the way in which they protect the privacy of customers who consent to share personal information with them.
Situation: Integrate.ai’s AI-powered tech helps clients improve their online experience by sharing signals about website visitor intent. They wanted to ensure privacy remained fully protected within the machine learning / AI context that produces these signals.
Situation: Novartis’ digital transformation in drug R&D drives their need to maximize value from vast stores of clinical study data for critical internal research enabled by their data42 platform.
Situation: CancerLinQ™, a subsidiary of American Society of Clinical Oncology, is a rapid learning healthcare system that helps oncologists aggregate and analyze data on cancer patients to improve care. To achieve this goal, they must de-identify patient data provided by subscribing practices across the U.S.
Situation: Needed to ensure the primary market research process was fully compliant with internal policies and regulations such as GDPR.
Situation: Needed to enable AI-driven product innovation with a defensible governance program for the safe and responsible use
of voice-to-text data under Shrems II.
This course runs on the 2nd Wednesday of every month, at 11 a.m. ET (45 mins). Click the button to register and select the date that works best for you.