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.
- 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
- 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
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