Bioanalytical Services

Our expert scientists will analyze your Research or Development study specimens (according to the applicable regulations), help you anticipate scientific or regulatory challenges, offer strategic solutions to enable you to make critical strategic decisions, and report your results in an appropriate format.   Our scientists have developed, validated and run multi-analyte methods containing up to 80 analytes (plus internal standards).   Specimen management services are also provided, including preparation of clinical specimen collection kits.

Method Development

For more than a decade, we’ve been developing analytical methods that meet (or exceed) our clients needs, including specificity and detection limits.   While quantification by HPLC-MS/MS is our specialty, we also have other capibilities, including UV and flow cytometry.

Bioanalytical Method Validation

Bring your own method or have us develop one for you, and we’ll validate it to your industry’s applicable bioanalytical standards.   Since 2008, we’ve validated more than 100 analytical methods.

Bioanalysis

We’ll analyze your specimens for exogenous (e.g., administered drugs) or endogenous (e.g., steroid hormones) compounds in our state-of-the-art laboratory with the finest instrumentation.   Specimen options include capillary blood collection (e.g.,using our patented amasse™ device) in addition to traditional venous blood/serum/plasma, urine, saliva, tissues and other media like H295R Human Adrenocortical Carcinoma Cells.

Compliance

We perform bioanalytical work in accordance with GLP and Electronic Records and Electronic Signatures regulations, and Bioanalytical Method Validation Guidance for Industry. We are inspected regularly (typically multiple times per year) by client and regulatory (FDA-CDER and EPA) auditors, and have an excellent inspection record.

We have more directed FDA inspections than the average CRO (one or more per year), because greater than 90% of clinical trial data we generate are submitted to FDA in support of bioequivalence.