“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...
To comply with the European Union Medical Device Regulation (MDR), medical device manufacturers are required to conduct...
Introduction During the conduct of a study, there may be instances where the study protocol is not...
In a dynamic manufacturing environment, changes are inevitable. Ensuring medical device safety is very crucial, particularly when...
Introduction The development of quality system procedures or standard operating procedures (SOPs) for conducting clinical trials of...
In a previous blog post, we highlighted the essential role of surface characterization in ensuring the biocompatibility...
Hippocratic Oath The Hippocratic Oath was likely written between the 5th and 3rd centuries BCE. Its purpose...
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...
Within the last five years, there has been significant advancement in chemical analysis and toxicological risk assessment...
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