Navigating Transparency Requirements Under the EU CTR with AI/ML-driven Solutions

Navigating Transparency Requirements Under the EU CTR with AI/ML-driven Solutions

How Can AI/ML Help with EU CTR?

As a clinical trial sponsor, the EU Clinical Trials Regulation (CTR) rules that become mandatory on January 31, 2023, will present new scalability challenges when it comes to ensuring that you maintain compliance and privacy protection throughout the clinical trial lifecycle.

This will be especially true during the trial setup and execution phases, which will require the publication of many documents not included in the scope of the previous EU Clinical Trial Directive.

In this webinar, David Di Valentino, PhD, AI/ML Solutions Lead at Privacy Analytics, shows you how AI/ML approaches combined with redaction and anonymization can help sponsors navigate the new transparency landscape under EU CTR.

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About this webinar

As a clinical trial sponsor, the EU Clinical Trials Regulation (CTR) rules that become mandatory on January 31, 2023, will present new scalability challenges when it comes to ensuring that you maintain compliance and privacy protection throughout the clinical trial lifecycle.

This will be especially true during the trial setup and execution phases, which will require the publication of many documents not included in the scope of the previous EU Clinical Trial Directive.

In this webinar, David Di Valentino, PhD, AI/ML Solutions Lead at Privacy Analytics, shows you how AI/ML approaches combined with redaction and anonymization can help sponsors navigate the new transparency landscape under EU CTR.

Presenter

David Di Valentino applies his expertise in data science and data analysis to help clinical trial sponsors maximize the analytical value of their data, while meeting global standards for patient privacy. Before joining Privacy Analytics, David had an extensive academic research career in particle physics. He published a number of papers, and gained expertise in software development, machine learning and data analysis.

David Di Valentino

CTT Data Scientist

Archiving / Destroying

Are you unleashing the full value of data you retain?

Your Challenges

Do you need help...

OUR SOLUTION

Value Retention

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.

Evaluating

Are you achieving intended outcomes from data?

Your Challenge

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OUR SOLUTION

Unbiased 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.

Accessing

Do the right people have the right data?

Your Challenges

Do you need help...

OUR SOLUTION

Usable and Reusable Data

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.

 

Maintaining

Are you empowering people to safely leverage trusted data?

Your Challenges

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OUR SOLUTION

Security / compliance efficiency

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.

 

Acquiring / Collecting

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

Your Challenge

Do you need help...

OUR SOLUTIONS

Consent / Contracting strategy

Client Success

Client: IQVIA

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

 

Planning

Are You Effectively Planning for Success?

Your Challenges

Do you need help...

OUR SOLUTION

Build privacy in by design

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.

 

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