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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....

Making Sense of Novel Real World Data to Improve the Development of Patient Relevant Endpoints: A New Framework

As part of achieving drug approvals and patient access, momentum is shifting from traditional methods of collecting and analyzing clinical...

Natural Language Processing Uses and Applications in Healthcare.

Natural Language Process (NLP)  Although human languages follow specific structures and patterns, they pose challenges for machines. In the early...

Social Media and Patient Communities

Social media has been around for about eighteen years now. More and more patients are using social media as an...

The Upcoming Clinical Trial Regulation and EMA Policy 0070 Restart? Are You Ready?

The conduct of clinical trials in the EU is expected to change greatly once the Clinical Trial Regulation 536/2014 comes...

FDA Regulations and Social Media Patient Experience Research

During drug development and later in health care research, researchers study patient experiences and behaviors to better design patient-centered care....

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...
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