BioVasc Inc. is a clinical development consultancy, accelerator and startup incubator for emerging BioPharma|Biotech|Medtech|Nutratech companies.
Many biomedical startups are seeking to rapidly obtain robust, meaningful clinical data on their technologies, greatly enhancing their valuations, without breaking the bank (we speak Startups!). Services include protocol development and active study execution for human proof of concept (POC) and first-in-human (FIH) studies, alignment of preclinical and nonclinical studies to support FIH (we speak Science!), execution of active phase clinical studies, and safety and medical monitoring of human studies (we speak Clinical!). Cross-coordination with other functions including regulatory affairs, data management, business development and other key project stakeholders for harmonization of objectives.
Special expertise in preclinical, translational and clinical development of new therapeutic products (biomolecules, small molecule drugs and medical devices), with notable expertise at the opportunity-rich convergence of biopharma & medical devices.
Protocol development and design; I speak science (molecular pharmacology background) and engineering (med device experience), facilitating interfaces with preclinical and nonclinical R&D teams for effective translation to human POC studies.
KOL and Advisory Board identification, interface and integration into strategic discussions, protocol and post-study analysis input, and study execution.
IRB (institutional review board) and DSMC (drug/device safety monitoring committee) onboarding, approvals, participation.
Clinical studies: first-in-human (FIH), human proof of concept (huPOC), PK, biomarker response, early stage (Ph1,2) safety, tolerability and efficacy studies.
BioVasc Inc. has not received any reviews.
BioVasc Inc. has not received any endorsements.