The Future of Clinical Document Submissions: 3 Strategies to Protect Your Brand

The Future of Clinical Document Submissions

3 Strategies to Protect Your Brand

The Future of Clinical Document Submissions: 3 Strategies to Protect Your Brand

Date of Event: March 4, 2021

Location: Virtual Event

Thursday March 4th, 2021 2PM EST (7PM GMT)

In this session, we’ll 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, BPharm, PHD, Senior Analyst, Clinical Trial Transparency, Privacy Analytics 
Lukasz Kniola, Principal Analyst – Data Sharing, Biogen
Sabrina Brown, Expert Transparency Manager, Novartis Pharmaceuticals Corporation

Event registration is now closed.

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

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