Some clients share with us that what keeps them up at night is how much of their projects (and what type of platforms/technologies) their bioanalytical lab can reliably perform. Some clients invest years of time in engineering & characterizing reagents, researching sample storage & transportation, and performing the methods – all with the focus of transferring those methods to a CRO.
Utilizing a single CRO to supply your sample collection kits, run your PK, PD, Biomarker and ADA assays should be considered when making decisions for pre-clinical and clinical trials. The list of benefits in placing all your assays and sample analysis with a single CRO offering a full portfolio of services includes:
- minimize sample volumes required to run all assays
- consolidate shipping
- limit project management burden for study directors as they interact with fewer labs
- facilitate collaboration between groups running different assays
- consistency throughout your program
Multiple sites require multiple sample aliquots, which can increase sample volumes to be shipped multiple times. Those sites often don’t have integrated systems and you end up dealing with multiple project managers. One can imagine a scenario where copious amounts of time and energy is lost managing multiple sites.
KCAS has worked hard to stand out in the market as a CRO that offers pre-labeled collection containers and shipping containers, single point of receipt and inventory with real-time notification of receipt to study sites and sponsors as well as laboratorians, coordination of study sample processing through various labs from dose form, LCMS PK and PD, protein LCMS or ELISA PK and PD, Biomarker analysis by ELISA, flow cytometry, or protein LCMS to anti-drug antibody analysis.
While the critical information for a GLP-Tox study is the pharmacokinetic and perhaps the anti-drug antibody data, there will be additional biomarkers which are indicative of efficacy; flow cytometry is one such biomarker that is often overlooked. Peripheral blood cells can be equally representative of drug mechanism of action which are easily obtained and phenotyped for this purpose. Regulation of specific surface or intracellular proteins, phosphorylation of specific proteins, modulation of protein expression as well as cell cycle, mitochondrial function and other cellular physiologic markers can be utilized for this pharmacodynamic measurement. Placing the flow cytometry studies with the same CRO as the PK and ADA work will allow the principle investigators to discuss mechanism of action, kinetics of the drug and facilitate complementary data integration.
Placing your study with a CRO like KCAS can minimize sample volumes required to run all assays, consolidate shipping, limit project management burden for study directors as they interact with fewer labs, and facilitate collaboration between groups running different assays. Your data can be harmonized from discovery to clinical trials providing consistency throughout your program. For the last several years we have been tactically focused on growing our services lines and expanding our current services. We have numerous business metrics to understand our capacity in order to ensure you can SAFELY and CONFIDENTLY place all your bioanalytical “eggs” in one basket …and get the results you need.