3 Ways to Safely Accelerate Your Clinical Document Submissions

3 Ways to Safely Accelerate Your Clinical Document Submissions

Find out which tech-enabled solution is best for you

As a clinical trial sponsor, you were already facing tight timelines and resource constraints in handling regulatory requirements for document anonymization and redaction.

Now, with increasing pressure to protect commercially confidential information (CCI) and mandatory compliance with EU Clinical Trials Regulation (EU CTR) coming on Jan 31, 2023, you’ll need to handle increased transparency demands on top of existing requirements under Health Canada Public Release of Clinical Information (PRCI) and future requirements under EMA Policy 0070.

The good news is we can help you safely accelerate submissions and protect the CCI you’ve identified for the broader range of clinical document types you now need to address throughout the trial application process.

Watch the replay of this webinar with Niamh McGuinness, Senior Manager of Clinical Trial Transparency and Privacy, Privacy Analytics, to learn about three solution options to help you meet your regulatory submission deadlines while protecting patient privacy and CCI. You’ll also see a demo of Mirage software, the natural language processing-powered tech behind each solution.

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About this webinar

As a clinical trial sponsor, you were already facing tight timelines and resource constraints in handling regulatory requirements for document anonymization and redaction.

Now, with increasing pressure to protect commercially confidential information (CCI) and mandatory compliance with EU Clinical Trials Regulation (EU CTR) coming on Jan 31, 2023, you’ll need to handle increased transparency demands on top of existing requirements under Health Canada Public Release of Clinical Information (PRCI) and future requirements under EMA Policy 0070.

The good news is we can help you safely accelerate submissions and protect the CCI you’ve identified for the broader range of clinical document types you now need to address throughout the trial application process.

Watch the replay of this webinar with Niamh McGuinness, Senior Manager of Clinical Trial Transparency and Privacy, Privacy Analytics, to learn about three solution options to help you meet your regulatory submission deadlines while protecting patient privacy and CCI. You’ll also see a demo of Mirage software, the natural language processing-powered tech behind each solution.

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

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Client: Comcast

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Evaluating

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Accessing

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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

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OUR SOLUTION

Build privacy in by design

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Client: Nuance

Situation: Needed to enable AI-driven product innovation with a defensible governance program for the safe and responsible use
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