Niamh McGuinness, PhD

Niamh McGuinness, PhD,

Associate Director, Safety, Regulatory & Transparency

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Niamh McGuinness is an expert in clinical trial document submissions and 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, Health Canada Public Release of Clinical Information (PRCI), and, more recently, EU CTR. Drawing on her academic research background, Niamh has helped develop Privacy Analytics’ CTT methodology and proprietary toolsets.

In fact, Niamh was one of the first hires for our CTT practice, at a time when  Policy 0070 had just come into full effect. She describes that period as a “baptism of fire” for both trial sponsors and service providers like Privacy Analytics.

Drawing on her academic research background, Niamh has helped develop Privacy Analytics’ CTT methodology and our proprietary toolsets. These toolsets automate many of the more tedious aspects of anonymization so that she and her team can focus their time on delivering higher value service to clients.

Niamh has personally managed many successful projects, with documents representing more than 100 clinical trials, some all the way to publication on the EMA’s Clinical Data Portal. She also led our first dedicated Health Canada PRCI submission. Under her watch, no client has ever missed a regulatory submission deadline or a deadline to make their trial data publicly available.

Today, Niamh shares her expertise in risk-based anonymization of clinical trial documents by attending and presenting at international conferences and forums. Recently, she took a seat on the industry’s Policy 0070 Working Group. The Working Group includes global pharmaceutical companies and other anonymization service providers.

“No matter what deadlines you face or how complex your documents, we can help,” Niamh says. “My team has the experience and the commitment to see that every project is done right. .”

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Archiving / Destroying

Are you unleashing the full value of data you retain?

Your Challenges

Do you need help...

  • Unleashing the full value of retained data so they can be put to work safely and responsibly in line with privacy regulation?
  • Defining and implementing effective archival and disposal processes for personal data?

OUR SOLUTION

Value Retention

  • Retain the business value in your data through anonymization.
  • Ensure compliance in your retention & destruction strategy.
  • Maximize the reuse of information by removing what is personal.

Client Success

Client: Comcast

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.

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Evaluating

Are you achieving intended outcomes from data?

Your Challenge

Do you need help...

  • Optimizing the use / analysis of data to achieve your organization’s intended outcomes with measured success?

OUR SOLUTION

Unbiased Results

  • Reduce / minimize risk of bias in your data for machine learning.
  • Ensure transparency, fairness, and AI ethics / compliance.
  • Ensure data ethics & compliance in your data models and results.

Client Success

Client: Integrate.ai

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.

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Accessing

Do the right people have the right data?

Your Challenges

Do you need help...

  • Ensuring the right people have access to the right data at the right times?

OUR SOLUTION

Usable and Reusable Data

  • Enable internal access and / or external sharing of data for primary and / or secondary uses.
  • Ensure data are useful and reusable in alignment with FAIR principles.
  • Ensure data have the right level of privacy protection for the use.

Client Success

Client: Novartis

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.

 

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Maintaining

Are you empowering people to safely leverage trusted data?

Your Challenges

Do you need help...

  • Maintaining / processing data securely and efficiently to promote data enablement with auditable proof of compliance?

OUR SOLUTION

Security / compliance efficiency

  • Creating synthetic versions of data to be used for innovation / AIML.
  • Applying data minimization principles to reduce your risk exposure.
  • Transforming your data for secondary uses and access.

CLIENT SUCCESS

Client: ASCO’s CancerLinQ

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.

 

Visit ASCOPubs.org to read the full story >

Acquiring / Collecting

Are you acquiring the right data? Do you have appropriate consent?

Your Challenge

Do you need help...

  • Ensuring the acquisition / collection of the right data under the appropriate consent / contracts to maintain corporate integrity?

OUR SOLUTIONS

Consent / Contracting strategy

  • Developing a consent / contractual framework for collecting / sourcing.
  • Creating a comms strategy for internal / external stakeholders.
  • Ingesting and transforming data safely to earn trust.

Client Success

Client: IQVIA

Situation: Needed to ensure the primary market research process was fully compliant with internal policies and regulations such as GDPR. 

 

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Planning

Are You Effectively Planning for Success?

Your Challenges

Do you need help...

  • Defining a clear data strategy to achieve desired outcomes?
  • Getting it right at the start to avoid costly privacy missteps later?

OUR SOLUTION

Build privacy in by design

  • Building privacy into your data plan / platform / pipeline upfront.
  • Establishing a trusted data strategy (ethics, compliance, privacy).

Client Success

Client: Nuance

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.

 

Visit Nuance.com to read the full story >

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