We provide analytical testing services to meet the research and development challenges of the pharmaceutical and biotechnology industry
Operating from our GLP/GCP-compliant laboratories in the US, we’ve provided bioanalytical support for over 4,000 studies for both small and large molecules.
Our responsive team of experts has earned a reputation for innovative method development as well as timely, high-quality analytical services that are personalized to meet each client’s specific application. We perform both stand-alone bioanalytical and immunoassay services, as well as the bioanalytical component of full-service packages across all phases of development.
Biomarker assays: Bioanalytical meets CLIA
Reliable diagnostic, prognostic, predictive, pharmacodynamic, and pharmacokinetic biomarkers are critical to assure correct patient selection, drug dosing, and monitoring to get a patient a drug that is going to work for them. How a biomarker assay is being applied to a drug's development will determine when an assay should evolve from research quality to a clinical diagnostic test. In this on-demand webinar we discuss biomarkers for use as exploratory, primary, and secondary clinical endpoints and the regulatory requirements associated with their context of use.
View the on-demand webinar
With over 1,500 assays developed in support of over 2,500 studies and with management experience averaging 21 years, ICON Development Solutions has the bioanalytical expertise and track record required to deliver rapid, dependable results.
ICON’s method development teams have extensive experience developing and validating robust bioanalytical methods in blood, urine and tissue specimens to support pre-clinical and Phase I through Phase IV clinical trials with an average method development/validation time of 12 days.
Through our dedicated and highly experienced Quality Assurance groups, we deliver QA approved data to our sponsors within 5 days of study completion or on a run-by-run basis if desired. All reports are produced to appropriate regulatory standards, either in the client’s own format or in the default ICON standard, and final QA reviewed study reports are available to sponsors within 12 days from study completion.
Facilities: Whitesboro, NY
This 48,000 sq. ft. facility in Upstate New York houses 7 laboratories, including a specially designed hazardous lab for the analysis of HIV & Hepatitis B infected samples. Opened in 1988; GLP compliant since 1989.