How to Protect Your Company’s Commercial Interest Under EU CTR

How to Protect Your Company’s Commercial Interest Under EU CTR

A complete solution for your clinical document submissions

 

About this webinar

As a clinical trial sponsor, you’re under pressure to be transparent, but how do you ensure your clinical study documents don’t reveal confidential trade secrets when published by regulators?

Starting January 31, when mandatory compliance with EU Clinical Trials Regulation (EU CTR) comes into effect, you’ll need to submit documents for eventual publication much more quickly than you did under EMA Policy 0070 and do under Health Canada PRCI – even if you choose the less-desirable option of deferral.

To help with this, Privacy Analytics offers a complete solution for your clinical document submissions, enabling you to meet your regulatory submission deadlines while protecting patient privacy and identifying and protecting commercially confidential information (CCI).

Join Niamh McGuinness, Senior Advisor, Clinical Trial Transparency and Privacy, to find out how Privacy Analytics can help you:

  • Avoid publication deferral
  • Identify and protect CCI
  • Shorten feedback cycles with regulators
  • Build an aligned transparency team

Presenter

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

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

Do you need help...

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

Do you need help...

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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