Introduction The underlying principle of a clinical study is to assess the safety and efficacy of an...
“What matters is this – will it help patients?” ~ Bill Cook Introduction To ensure that patients...
Introduction The third revision (R3) of the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) was...
In a dynamic manufacturing environment, changes are inevitable. Ensuring medical device safety is very crucial, particularly when...
In a previous blog post, we highlighted the essential role of surface characterization in ensuring the biocompatibility...
A clinical study process that is often underappreciated is close-out. Regardless if the study was completed or...
Great job on completing enrollment! Reaching this major milestone is a big accomplishment as it marks the...
Within the last five years, there has been significant advancement in chemical analysis and toxicological risk assessment...
In a clinical research trial, or study, various roles are crucial to ensuring the study’s success and...
Finding the least burdensome pathway to address biocompatibility requirements can be a challenge. Coupling our engineering and...
Clinical research for pharmaceuticals and devices follows the same general path. The first trial is a small...
Decentralized clinical trials (DCTs) are becoming increasingly popular, with the increased use of electronic systems and novel...
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