GBC Partners with Boudicca DX to Become a One Stop Global Shop for Strategy and Execution for Medical Device & In Vitro Diagnostic Companies

See press release here: https://lnkd.in/e8tBZd6Z


February 12, 2025. Boudicca DX a global precision medicine consulting firm with
operations in the United States (Boudicca DX, LLC) and Ireland (Boudicca DX Limited) is
excited to announce its partnership with Global BioClinical, a boutique Clinical Research
Organization (CRO) that has successfully executed over 30 global medical device (MD), in
vitro diagnostic (IVD), and pharmaceutical clinical trials for over 14 biotech and pharma
companies with broad experience in autoimmune diseases, chronic diseases, infectious
diseases, and oncology. Dr. Kelly Gordon, Chief Executive Officer and Founder of Boudicca DX, stated:


“After evaluating multiple CRO organizations, we selected Global BioClinical
as our preferred CRO partner based on their deep expertise and understanding
of medical device and in vitro diagnostic global clinical trials. Our emerging
clients need a CRO that is budget-conscious, efficient and qualified to ensure
that all clinical, quality and regulatory compliance requirements are met
during clinical study set-up and execution since our emerging clients only have
one shot on goal. This partnership will bring comprehensive clinical operations
support to our current and prospective clients that is complementary to our
quality, regulatory and translational support.”


Neil Mucci, Founder of Global BioClinical, stated:


“The Global BioClinical team is pleased to announce its partnership with
Boudicca DX to offer complementary services to support product
development, clinical validation and utility studies. We aim to leverage our
operational and execution-oriented capabilities alongside Boudicca DX’s
quality, regulatory strategy, and translational expertise to provide a
comprehensive service solution. This collaboration is designed to enhance
client return on investment and expedite candidate products to the market.”


Boudicca DX’s established quality, regulatory, and translational team will work in tandem
with the Global BioClinical team to provide comprehensive and seamless support to global
MD and IVD clients, reducing both time and financial burden for clients setting up clinical
feasibility, validation, and utility studies to generate the data needed to get their precision
medicine products to the market and to support reimbursement. Global BioClinical’s expert
team delivers a comprehensive, cost-effective CRO solution, offering full-service support for
clinical study documentation, data management, and IRB and Ethics Committee
submissions, as well as clinical site management services including qualification, initiation,
training, monitoring and close-out.