Archive for April 2022

AARDEX® Group adds etectRx’s Smart Pills to their MEMS® Adherence Hardware ecosystem 

Smart Pills

The partnership sees the integration of AARDEX’s adherence analytics software with etectRx’s ingestible adherence sensor smart pill. Liege, Belgium (APRIL 28, 2022) – Belgium-based AARDEX Group, the leader in measuring and managing medication adherence in clinical trials today announced a strategic partnership with etectRx, Inc. This new collaboration combines etectRx’s smart pill, the ID-Cap™ System, and AARDEX Group’s MEMS Adherence…

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FDA Issues Draft Diversity Guidance to Improve Enrollment of Participants from Underrepresented Patient Populations

FDA Diversity Guidance

Diversity in clinical research is a growing concern for sponsors as many factors can influence how an individual may react to certain drugs: age, biological sex, disabilities, chronic comorbidities, geographical location, gender identity, race, and ethnic background.  Thus, if the investigational product is to be scrutinized for safety and efficacy effectively, a diverse population of…

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Optimizing Study Design to Tackle Protocol Deviations in DCTs

Protocol Deviations in Decentralized Trials

Decentralized Clinical Trials (DCTs) are here to stay, as demonstrated by international regulators’ recent commitments to the model. But while the approach offers a multitude of benefits, from expanding access to increasing cohort diversity, it can also serve to magnify existing protocol deviations such as poor adherence to the dosing regimen. If we are to…

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Harnessing Digital Health Technology to Bolster Study Power

In a world of big tech, data is king. This slogan is far from news for the Biopharmaceutical Industry, but clinical trials are lengthy, complex, and expensive, meaning precious information isn’t always utilized to its maximum potential. In recent years, a slew of Digital Health Technologies (DHTs), designed to collect and share data remotely, have…

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