Category: Uncategorized

Unlocking the Secrets: Navigating Company Confidential Information (CCI) in Clinical Trial Transparency

In the realm of clinical trials, transparency is not just a buzzword but a fundamental principle guiding the advancement of...

The EMA Policy 0070 and Health Canada Public Release of Clinical Information (PRCI) Anonymization Report

How the New Anonymization Report Template Impacts Study Sponsors Collaboration between Health Canada & EMA While Health Canada PRCI and...

Anonymization Primer - Health Canada PRCI: Personally Identifiable Information

Health Canada has published guidance documents for submitting new drug submissions and device applications. In particular, these guidelines provide direction...

Anonymization Primer: Adversaries - The Risk of Re-Identification

Health Canada has updated several policies to encourage transparency and data sharing in clinical trials, which in turn, will encourage...

Anonymization Primer: Participant Privacy Risks

Medical researchers from pharmaceutical industries and academia are increasingly engaging in the secondary analysis of unstructured data or unstructured clinical...

Research Ethics In Social Listening

In recent years, clinical researchers have adopted social listening as a technique while conducting social media studies to gain a...

Health Canada PRCI & EMA Policy 070. The shift toward Quantitative Risk Assessment.

Significance of data anonymization In the healthcare domain, regulatory authorities promote clinical trial transparency by providing reporting guidelines. These guidelines...

The “What” and “Why” of Health Data Anonymization and how Pharmaceutical Sponsors and Contract Research Organizations need to prepare

Do we really need to share health data?  The answer, when discussed across health care organizations varies. However, regardless of...

Recent Global Regulatory Trends in Health Data Sharing and Data Anonymization

Our industry is at an interesting crossroads.  On one hand, pressure to share clinical and real world data is increasing. ...

Applying Key Learnings From Health Canada PRCI to EMA’s Regulation EU CTR No. 536 and Policy 0070

We often receive questions from sponsors about Regulation EU No. 536 which is expected to take effect later in 2021....
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