Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite.
By Zach Weingarden
Clinical trial transparency is quickly emerging as a critical function within sponsor and academic organizations, as its importance in the pharmaceutical, biotechnology, and medical device industries increases. Understanding data anonymization techniques and tools is an important part of adhering to increasing regulation.
In the last five years alone, we have seen the introduction of numerous country-specific transparency regulations, industry guidelines, and requirements, including EMA Policy 0070 and FDAAA 801, for instance.
In the imminent future, even more regulation, such as the full implementation of the EU Clinical Trial Regulation and associated Clinical Trial Information System (CTIS), and increased scrutiny and focus on data transparency are expected.
These changing and increasing requirements force sponsors to adapt quickly, especially when it comes to data anonymization. Those who are not able or willing to do so face increased public pressure, the potential of penalties for non-compliance, and issues le...
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