Niamh McGuinness, PhD
Associate Director, Safety, Regulatory & Transparency
Transparency-by-Design: Build Efficiencies into Your Clinical Document Disclosure Process
Date of Event: March 7, 2024
Location: Virtual Event
8:00 AM or 11:00 AM Eastern Standard Time
Duration: 30 minutes
Since the 2023 relaunch of EMA’s Clinical Data Publication Policy (EMA Policy 0070), clinical trial sponsors have seen a marked uptick in regulatory requirements for clinical document publication.
As these documents contain dense personal and commercially confidential information (CCI), protecting this information—through redaction or statistically derived transformation—can pose a significant challenge.
With public document disclosure becoming integral to the clinical trial lifecycle, you can reduce this burden by incorporating best practices in writing transparency-friendly clinical documents.
Join Niamh McGuinness, Associate Director, Safety, Regulatory & Transparency, to find out:
Sign up for either session (or both) to see a short presentation followed by a chance to ask your most pressing questions about EMA Policy 0070 and transparency-friendly clinical documents.
Niamh McGuinness is an expert in clinical trial document submissions and a senior member of the Privacy Analytics team, focused on Clinical Trial Transparency (CTT). She has personally managed many successful projects, with documents representing hundreds of clinical trials. Under her watch, no client has ever missed a regulatory submission deadline or a deadline to make their trial data publicly available.
Niamh’s team works with a variety of clinical trial sponsors that have turned to Privacy Analytics to meet the stringent requirements of regulations such as EMA Policy 0070, Health Canada Public Release of Clinical Information (PRCI), and EU CTR.
Niamh McGuinness, PhD
Associate Director, Safety, Regulatory & Transparency
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.