Partnership Philosophy
We collaborate exclusively with multi-specialty clinical practices that demonstrate commitment to research excellence. Our boutique network approach ensures dedicated resources, specialized training, and sustained engagement throughout study duration.
Clinical Leadership: Founded and led by experienced clinical research professionals with 20+ years operational expertise and established thought leadership in the field.
Operational Excellence: Comprehensive site support including feasibility assessments, regulatory submissions, automated invoicing systems, and integrated technology platforms.
Our Network
Multi-Specialty Clinical Partners: We collaborate with established clinical practices that integrate research as a core component of patient care. Our network includes:
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Primary care and family medicine practices
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Specialty clinics (infectious disease, cardiology, endocrinology)
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CLIA-certified laboratories (waiver through moderate complexity)
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FWA-registered research sites
Network Capabilities
Geographic diversity across key metropolitan and rural areas
Regulatory compliance infrastructure in place
Established IRB-approved protocols for prospective collection and remnant retention.
Human Factors and In Vitro Diagnostics: Two sides of the same coin. Diagnostic devices are operated by humans: clinicians, technicians, medical assistants and lay users. We have found that our Diagnostic Device clients get the maximum benefit from our partnership when the clinical studies have effective overlap with requisite Human Factors studies. Clients and sponsors should be sure to ask us about this unique and novel collaborative approach.
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Our Approach
ClinicaGen Bio bridges sponsor objectives with clinical site capabilities through three core competencies: specialized personnel who understand non-interventional research requirements, meticulously planned processes that harmonize research with existing clinical workflows, and innovative technology solutions designed specifically for minimal-risk studies.
Novel and Beneficial Approach:
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Historically, biospecimen research and procurement has been perceived as a small, nearly insignificant, contributor to the clinical research industry ecosystem.
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Advancements in medicine through clinical research hinge on qualified site engagement in the clinical trial process.
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ClinicaGen Bio only selects and trains sites that will dedicate their clinical expertise, lab resources, and intellectual curiosity to the goal of contributing quality biospecimens and associated clinical data to the clinical research sphere.
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These sites understand the necessity of accrual rates meeting deadlines and with our consulting, our clients receive samples within the time frame projected.
Leadership
Missy Farrell, BSN, RN,
Registered nurse with over 20 years of clinical research experience across diverse healthcare settings. Provided strategic consultancy to clinical sites, CROs, IRBs and industry sponsors. Previously served as Senior Director of Clinical Operations in the biotech/CRO sector. ACRP CCRC certified and published author with ACRP and SOCRA.
Linda Hernandez, MHA
Linda Hernandez, MHA is Senior Director of Clinical Research at CGB with over a decade of experience in clinical research, specializing in vitro diagnostics for infectious diseases. She has led numerous clinical trials, providing regulatory oversight and site management across all study phases. Ms. Hernandez holds a Master of Health Administration and is committed to advancing diagnostic innovations while fostering collaborative research environments.
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