PATTERN_BLUE_1320x780_3 Blogs
Read article Pharmacokinetics at KCAS: An Orchestrated Approach

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…

PATTERN_AMBER_1320x780 Blogs
Read article Applying GLP Standards to Sub-Ambient Sample Storage at KCAS

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…

PATTERN_ORANGE_1320x780 Blogs
Read article Flow Cytometry: Tailored Solutions without Additional Qualification

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…

PATTERN_ORANGE_1320x780_2 Blogs
Read article Common Rule – Who decides what happens to your samples?

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…

KCAS-blog-thumb_David-vs-Goliath Blogs
Read article Boutique CROs: Being David in a land of Goliaths

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…