Clinical Trial Services

CIrIOn is a Contract research Laboratory and a leading provider of Global Central Laboratory and r&d services for assay development & validation for Global Clinical Trials and pre-Clinical studies. The company offers a complete range of project management and logistical services, a broad portfolio of safety and esoteric assays, including biomarkers, and high level scientific expertise. CIrIOn has over 14 years experience in developing and validating assays in a GLp environment. The company is accredited by the College of American pathologists (CAp), the Centers for disease Control (CdC) and the nGsp.

ciRion clinical trial services inc.

Our mission is to provide unsurpassed excellence in services through our state-of-the-art Global Central Laboratory which is enhanced by the scientific capabilities and know-how of a highly skilled research laboratory team. Our expertly trained scientists work in an environment supported by high-tech computerized management systems and laboratory equipment.

Our expert team is committed to quality assurance exceeding industry standards to ensure reliable results and uncompromised service.

global, Full service central laboratory:

• Global project management and Logistics • Management of complex studies • International Site Support • Worldwide Shipment Management and Tracking • IATA-Compliant Specimen Collection Kits • Customized Study Material • Analytical Services with rapid turnaround time • Broad Portfolio of Specialized Assays and Biomarkers • GLP-Compliant Specimen Storage • Flexible Reporting Capabilities • Data Management with Real-Time Data Cleaning • Web Tools and Remote Data Access

Development & Validation services

scientific partners for your development programs. Our scientific team support GLp and non-GLp services:

expertise/large Molecules:

Biologics/Biosimilars: we can support your product development, pre-clinical and clinical development by getting involved early in the development process: • PK assays (including ISR) • Immunogenicity testing (ADA, Nab) : Screening, Confirmatory and neutralizing activity antibody Biomarkers: In this area, for small or large molecules, CIrIOn’s scientists have gained expertise from various technologies with solid knowledge. method planning can be adapted depending on your study protocol: • Exploratory assay • Partially GLP validated assay • Full GLP validated assays

technologies:

mass spectrometry: • LC-MS/MS (QTrap) • Seldi-Tof ProteinChip System Cell based assays: • Neutralizing antibody assay (Nab) • Activity/Potency assay • Cell proliferation • Cell Line conditioning and characterization Immunology: • RIA, IRMA, EIA, ELISA, ELISPOT and binding assays • Single and multiplex assays by Electrochemi-luminescence (ECL) (meso scale® platform) • Single and multiplex assays by xMAP technology (Luminex® platform) • Immunophenotyping by Flow Cytometry • Biosensor technology on Biacore® platform Molecular Biology: • DNA and RNA extractions • Real time RT-PCR • Viral quantification microbiology: • Antibiotic susceptibility (MIC assay and E-test) • Microorganisms identification (API test)

By-the-Book Quality:

• Strict adherence to GCP & GLP regulations • CAP/CDC Accredited