Worldwide Clinical Trials' Bioanalytical Laboratory

WHAT SETS OUR BIOANALYTICAL LAB APART?

We deliver uncommon value. From discovery to post-marketing, we partner with your team to develop a custom method, transfer/optimize and validate an existing method, identify liabilities and de-risk a regulated assay, or adapt a method to increase efficiency and cost-effectiveness. The keyword here is partnership – you’re more than a molecule to Worldwide! We know your early phase development comes with high stakes, and we take that seriously.

One way we demonstrate our commitment to customers is by focusing on quality. Our inspection history from 2011 to present-day has consistently resulted in no observations, attesting to our focus to provide the highest quality data possible.

We know that cost will always be a factor for your organization – but not at the risk of quality. Our team provides quality service with rapid turnaround at a competitive cost. You can rely on strong scientific expertise at our Bioanalytical Laboratory in Austin, TX. Our scientists routinely analyze more than 30,000 samples per month and have demonstrated capability up to 45,000 samples per month.

With state-of-the-art instrumentation and more than 2,400 validated assays, we are at the forefront of the industry in the development of bioanalytical methodology.

Our bioanalytical work meets all regulatory standards, including:

• FDA Regulations (US Code of Federal Regulations, 21 CFR) for Good Laboratory Practice, Good Clinical Practice (GCP), Bioavailability and Bioequivalence Requirements, conduct of clinical trials, and human subject protection.
• European Clinical Trials Directive 2001/20/EC and Commission Directive 2005/28/EC.
• UK Medicines and Healthcare Products Regulatory Agency (MHRA) requirements. Our quality assurance and quality control processes add another level of oversight. Let us demonstrate our excellence!