ICON is a global leader in addressing US FDA and European IVDD (IVD Directive) regulatory and clinical trial requirements for in vitro diagnostic devices and biomarker research.
Our experience includes work on more than 120 in vitro diagnostic (IVD) projects, ranging from traditional IVD assays to molecular diagnostics, and IVDMIAs. We specialise in all phases of diagnostic research, including discovery, development and validation, and commercialisation.
Identifying high-volume real-world sites, ensuring robust sample integrity, and rapidly and seamlessly processing samples is critical to IVD and biomarker research. ICON’s local knowledge of cultures, beliefs, and regulatory environments—and our relationships with physicians around the world—allow us to manage both large and small projects throughout the US, EU, and Asia-Pacific regions ensuring a cost-effective, streamlined global operational approach.
We consolidate, automate, and reduce manual effort with a central monitoring approach
Our unique central monitoring approach provides high-quality data that can be analysed and acted upon at the sample, patient, site, and project level, ensuring high sample viability. Our operational model maximises site participation, provides proactive support to potential high-volume and active sites, and uses real-time information to focus on the most important thresholds, triggers, and trends to help sponsors achieve their primary study objectives.
We’ve developed proven strategies to:
- Identify and select sites where known patient populations exist
- Ensure rapid study start-up
- Streamline site management and monitoring
- Manage samples and logistics efficiently
- Collect high-quality data
Timely and seamless global clinical trial testing and support
A well-defined plan for clinical trial sample collection, processing, and logistics is the only way to ensure high-quality study data. Our scientific experts use analytics to proactively follow the sample chain of custody processes to address issues early, allowing us to see trends of non-viable samples for mitigation. Our teams are also well-versed in import/export restrictions and local regulatory environments.
Our diagnostics therapeutic experience includes:
- ELISA assay for identification of Borrelia burgdorferi (Lyme disease)
- Point of care and laboratory diagnostics for detection of STDs
- H. pylori breath test (analyser and disposable)
- PCR amplification and detection system for infectious agent
- CD4/CD8 cell monitoring system for HIV status (analyzer and reagents)
- Independent positive and negative controls for infectious disease testing QC/QA
- Genetic markers for detection of lung, colorectal, and bladder cancers
- Companion diagnostic for colorectal cancer
- Melanoma detection
- Breast cancer diagnostic
- Cervical Cancer Screening System (analyser and reagents)
- Immunoassays for detection of tumor-associated antigens (analyser and reagents)
- Cardiac inflammation-marker
- ELISA assay for aid in diagnosing congestive heart failure (CHF)
- Diagnostic tools for management of cardiovascular risk factors
- Cardiac damage biomarker
Clinical Laboratory Test Systems, Reagents, and Instrumentation
- Hematology and immunology systems (analyser, reagents and controls)
- Point-of-care devices for hemoglobin testing
- Analyser and test system for detection of gynecological conditions
- Automated gene expression test system
- Molecular diagnostic test for single and multiplexed nucleic acid amplification assay
- Specimen collection and transport swabs and media
- DNA probe-based system for quantitative detection of specific nucleic acid sequences
- Cerebral Tissue Monitoring System (probe and accessories, analyser and reagents)
- Endotoxin Activity Assay (analyser and reagents)
- Genotyping assays for smoking cessation/IVD MIA