What you don’t know about how an off-the-shelf Biomarker kit is evaluated and qualified can significantly compromise your biomarker data. Running the kit using the manufacturer’s instructions without systematically testing the accuracy/precision (A/P), range of quantification (ROQ), dilutional linearity (DL), stability, and selectivity can jeopardized the interpretation of the results.

Like the old adage, “you get out of it what you put into it,” good study design is a prerequisite of good data. To boost the chances of generating accurate and informative facts over the course of a study, it is key to consider all of the supporting parameters that…

Finding a laboratory to successfully transfer and GLP validate your PK method can be a challenge. Yes sure the big labs can do it, but if you are not a preferred provider you may find yourself working with the B team that doesn’t move as fast as you need, and…

There is regulatory requirement that the cumulative time a frozen pharmacokinetic sample has been thawed – from the time it’s removed from the freezer to the time it’s returned – be documented. Freeze/thaw cycle data is not deemed sufficient alone, since a study sample might have been thawed for extended…

The challenges and obstacles to including flow cytometry in multi-center clinical trials are well-known. The solutions the KCAS team offers can eliminate risks commonly associated with lost or delayed shipments and allow for batching, which reduces the overall cost of conducting flow cytometric testing. As a result, our customers can…

The Department of Health and Human Services (HHS) has issued long awaited, comprehensive update on how medical research should be conducted. The Common Rule, 45 CFR 46 subpart A, issued 26 years ago and established basic protections for human subjects in research conducted by or supported by the HHS and…

In today’s drug development arena, massive, multinational CROs dominate the industry. They offer a “one stop shop” suite of services covering Early Development to Phase IV Clinical Trials and everything in between. Although multinational…