Specialised CLIA-certified clinical testing services for pharmaceutical customers
We offer specialised CLIA-certified clinical testing services for pharmaceutical customers throughout their ongoing late-stage and multi-year clinical trials for cancer therapies, which require dedicated trial management services and logistics.
We undertake biomarker studies of various scope and scale ranging from pre-clinical or Phase I exploratory studies to large international Phase III/IV pivotal trials. This includes LDT development, which can be used for patient enrollment and/or monitoring, as well as clinical trial design and trial site support, which includes sample management and data management/reporting.
Clinical Trial Service Capabilities
Our team has experience performing mutation detection, copy number variation, structural variants, gene expression and protein tissue expression through immunohistochemistry (IHC), leveraging a complete range of both RUO and FDA IVD cleared platforms. These services include tissue processing, embedding and sectioning, data interpretation, digital imaging and reporting, custom IHC assay development, and biorepository and sample storage.
We have an established framework for bringing a prototype clinical trial assay along the codevelopment continuum into a companion diagnostic. With more than a decade of experience working with different clients, ICON Specialty Laboratories has the facilities and skilled intellectual capital to work together as a cohesive team.
Each client’s programme, consists of a tailored project management team assembled from relevant functional areas, depending upon the scope and requirements of the study. Our dedicated project managers facilitate collaboration between sponsors, clinical trial investigators, regulatory teams and subject matter experts to ensure trial success.
Our regulatory team routinely submits data and filings to the FDA and ex-US regulatory agencies:
- Study Risk Determinations (SRD)
- Investigational Device Exemptions (IDE)
- Premarket Approval Submissions (PMA)
- Health Canada
CAP/CLIA Certified Laboratories
Our two CAP-accredited / CLIA-certified laboratory sites, located in Cambridge, MA and Portland, OR, track patient samples, providing chain of custody from accession, extraction, testing, data management and results reporting. All stages of the process are conducted internally and information can be made available at a sponsor’s request.
We offer customised test report formats and distribution capabilities designed to meet the needs of clients, investigators and regulators. We support patient specimen collection with custom collection kits and shipping logistics.
State certifications for the Portland lab include California, Florida, Maryland, New York, Pennsylvania and Rhode Island. The Cambridge lab maintains Massachusetts state certification.
Discover more about ICON's certifications, licenses and accreditations.