Abby McDonell
Senior Clinical Trial Transparency Program Manager
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Transparency-by-Design: Build Efficiencies into Your Clinical Document Disclosure Process
Date of Event: November 7, 2024
Location: Amsterdam Marriott Hotel, Amsterdam, The Netherlands
Abby McDonell, Privacy Analytics’ Senior Program and Project Manager, Clinical Trial Transparency, will be presenting at the Conference on Thursday, November 7 (10:00am–10:30am CET)
Since the introduction of EMA’s Clinical Data Publication Policy, sponsors have been grappling with a unique problem – the timely and accurate capture and protection of personal and commercial data contained in clinical trial documents. As this information is often dense, varied, and buried in lengthy unstructured text, its post-hoc protection through redaction or statistically derived transformation can pose a significant challenge.
As public document disclosure becomes an integral part of the clinical trial lifecycle, sponsors could proactively reduce this burden by incorporating best practices in writing transparency-friendly clinical documents. Join Abby McDonell, Sr. Program Manager with IQVIA’s Clinical Trial Transparency Team (powered by Privacy Analytics) to gain some actionable insights on how to optimise your medical writing processes to simplify downstream disclosure and transparency initiatives whilst ensuring participant and commercial data privacy remains protected.
As a Senior Clinical Trial Transparency Program Manager with IQVIA’s Privacy Analytics, Abby leads an international team leveraging AI-enabled technology to deliver world-class anonymization services, meeting the disclosure and data-sharing needs of Top 10 Pharma customers. Drawing from an extensive academic research background, Abby ensures her expert team deliver to the highest standards of regulatory compliance whilst fostering an environment of continuous improvement and operational excellence. Abby also leads the PHUSE Good Transparency Practice working group, lending her expertise in developing industry standards for increasing safe and responsible clinical data publication across the trial lifecycle.
Abby McDonell
Senior Clinical Trial Transparency Program Manager
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.