Services
Our focus is to provide medical/clinical affairs consulting expertise to medical device, IVD and Pharma (especially with companion diagnostics) companies on medical risk determinations and pre-submission expertise for new IVD assays.
We have experience in the design and execution of over 30 clinical trials spanning Pharmaceutical (phase 1-4), medical device (IDE) and IVD (IDE and PMA). This experience helps our clients solve complex clinical/regulatory challenges that they encounter. Our experience spans a wide array of products, across a wide array of therapeutic areas.
Our therapeutic experience includes cardiovascular, anesthesia/pain, critical care, infectious disease, oncology and maternal-fetal medicine.
New Product Development
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Clinical needs assessment:
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Target product profile
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User needs
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Product requirements
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Regulatory strategy – clinical plans
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Risk management plans
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Including, on-market product safety
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Clinical Trial Strategy
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Clinical development plans
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IND, IDE and PMA
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Protocol design
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Medical monitoring
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Clinical data analysis
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Clinical study report preparation
Clinical Marketing
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Clinical value proposition
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Competitive market analysis
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Voice of customer research
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Advisory board development
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Publication planning
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Post-market study planning
New Ventures
New Ventures
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Due diligence support for business development activities
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Startup creation and operation
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New venture funding