The Future of Clinical Document Submissions

The Future of Clinical Document Submissions

3 Strategies to Protect Your Brand

 

About this webinar

In this session, we discuss the three strategies you need to consider when planning your approach to submitting clinical trial documents in 2021.

As privacy concerns continue to make headlines in the pharmaceutical space, sponsors face growing pressure to meet ever stricter regulatory requirements to anonymize clinical trial document submissions. To stay resilient, your organization must employ an approach that shields it from further regulatory shifts.

Featured Topics:

  • Globally accepted best practices for document anonymization
  • How to produce insight-rich clinical documents that are safe for public sharing
  • The role of knowledge exchange in protecting against unforeseen regulatory demands

Learning Objectives:

  • Recognize what statistical anonymization is and how it can be applied to clinical documents
  • Evaluate whether do anonymization in-house, with software, or through a service provider
  • Identify the strategic benefits of joining an engaged community of thought leaders

Presenters

Niamh McGuinness, PhD, Senior Analyst, Clinical Trial Transparency, Privacy Analytics
Lukasz Kniola, Principal Analyst – Data Sharing, Biogen
Sabrina Brown, Expert Transparency Manager, Novartis Pharmaceuticals Corporation

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 CTT Analyst

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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