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Immunoassay kit for detection of sepsis
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Early-stage regulatory support to include study design, statistical analysis plan, and pre-IDE interactions with FDA.
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Prognostic assays for breast, colon, and prostate cancers with companion therapies
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Assist global manufacturer with strategic commercialization planning, including U.S. and international regulatory requirements, resource planning, and timelines.
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Assay for tissue typing
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Full clinical trial support for large U.S. manufacturer, including project management, resource planning, site selection and qualification, monitoring, data management, biostatistics, and report writing.
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Immunological assays for prostate, breast, and colon cancer
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Provide regulatory counsel and FDA interaction support for European manufacturer.
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Immunological and molecular diagnostics for use in in vitro fertilization
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Assist global manufacturer with strategic commercialization planning, to include regulatory affairs, resource estimation, and timelines.
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Blood-based assay for screening of colon cancer
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Provided regulatory counsel to venture capital group on likelihood, requirements, and merits of FDA IVD vs. CLIA pathways.
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Blood group reagents
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Filed BLA efficacy supplement for blood group reagents
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Immunological assay to detect neurodegenerative disease
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Assist European manufacturer with indications for use, regulatory pathway, and FDA interactions.
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Flow cytometry for stem cell enumeration
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- Clinical project management services for a manufacturer of IVD reagents and instrumentation
- Oversight and conduct of site selection and site qualification
- Protocol and case report form development
- Study conduct (monitoring and closeout)
- Serve as clinical operations representative for the manufacturer’s core development team and is responsible for working with staff to set and meet project timelines
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Immunohistochemistry assay to detect prostate cancer
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- Regulatory assessment and strategy
- Pre-IDE meeting
- Clinical trial (impending)
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26 monoclonal antibody-based blood grouping reagents;
2 anti-human globulin products;
13 reagent red blood cell products; and supplements to 3 previously licensed reagents
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- Earned multiple BLA and BLA supplement approvals (biologics license applications)
- Project management
- Quality assurance program
- CMC (chemistry, manufacturing, and controls) systems and procedures
- Process validation protocols and report writing
- Stability test protocols, test methods, and acceptance criteria
- In-process product testing plans and acceptance criteria
- Established product specifications such as potency, specificity, and microbial limits
- Facility and utility controls and prepared validation packages
- Statistical analysis of clinical data for final clinical report
- Served as client’s U.S regulatory contact for FDA interactions
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Instrument and DNA primers for K-RAS mutation detection kit
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- Regulatory assessment
- 510(k)
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Point-of-care test for counting blood cells and quantifying hemoglobin content
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Regulatory assessment on modifications to blood cell analyzer
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Assay to detect marker response to a drug therapy
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- Regulatory assessment
- Regulatory strategy
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HgB A1C point-of-care device
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- Site selection
- Data collection and management
- Study management
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Immunohistochemistry assay to detect breast cancer
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- Regulatory assessment
- 510(k)
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Genetic marker to detect human papillomavirus (HPV)
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Regulatory assessment
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Molecular genetics assay to detect cystic fibrosis
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- Site qualification
- Clinical monitoring
- Data management
- Statistical analysis
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Cell separation product
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- Full project strategy development
- FDA meeting preparation and participation
- Manufacturing validation and quality system support for antibody production
- Study management
- Clinical monitoring
- Biostatistics
- 510(k)
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Microarray-based karyotyping test
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Regulatory assessment to explore FDA pre-IDE path versus CLIA lab certification
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Numerous blood glucose monitors
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- Regulatory strategies
- CLIA waiver
- Numerous 510(k) submissions
- Quality systems implementation
- Study management
- Clinical monitoring
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Genetic screening for congenital indication
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- Project strategy
- Protocol
- IRB approvals
- Sample procurement
- Data management
- Clinical monitoring
- Statistical analysis
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Breath sensor array device for detection of lung cancer
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- Regulatory assessment
- Regulatory strategy
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Reagents for immunoassay analyzer — chemistry assays, hormone level assays, etc.
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- Product development team member (strategy development, review of testing documentation, labeling, etc.)
- Development and review of 510(k) submissions
- Development and review of international submissions (EU, Japan, etc.)
- Development and review of request for classification
- Development of regulatory documentation for support of international clinical study
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Reagent panel for ABO typing
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- Clinical site monitoring
- Clinical data management for 10,000 samples
- Clinical report generation for BLA support
- Preparation and review of BLA submission
- Quality system support for reagent manufacturer
- Manufacturing validation and quality system support for antibody production
- FDA meeting preparation and participation
- FDA inspection preparation and participation (two foreign facilities)
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Cancer tissue marker
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- Full project strategy development
- Review and development of 510(k) submission
- Clinical data management and report generation for 510(k) support
- FDA meeting preparation and participation (three)
- Clinical study protocol design for PMA clinical support
- Clinical data management for more than 2,000 subjects and samples
- Clinical site monitoring
- Quality system development, implementation, and support
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Hepatitis diagnostic
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- FDA meeting preparation and participation
- Product development team member (review testing, labeling, etc.)
- Regulatory submission strategy and review - PMA and 510(k)
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