Transparency-by-Design: Build Efficiencies into Your Clinical Document Disclosure Process

Transparency-by-Design

Build Efficiencies into Your Clinical Document Disclosure Process

About this webinar

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.

Watch this presentation, hosted by Niamh McGuinness, Associate Director, Safety, Regulatory & Transparency, to find out:

  • What makes a clinical document transparency-friendly?
  • How do you incorporate best practices into your current initiatives?
  • How can our complete solution help you satisfy 3 key requirements – EMA Policy 0070, EU CTR, and Health Canada’s PRCI?

Presenter(s)

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

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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