CHIMunomics, Ltd.
Consultancy and clinical-trial services focused on infectious diseases. Services include design and implementation of clinical trials (including controlled human infection/human challenge trials), regulatory strategy and dossier preparation, clinical data analysis, project and trial management, and advisory support for bacteriophage clinical development. Founded in January 2023 from a buy-out of a challenge-agent specialist.
Industries
N/A
Nr. of Employees
small (1-50)
Services
Consultancy for trial design, documentation and operational implementation in infectious disease clinical development.
Advice on design, execution and analysis of human challenge trials and challenge agent use, from protocol through to clinical study report.
Support for the design, execution and analysis of clinical trials involving bacteriophage therapeutics.
Reanalysis of trial data to identify significant outcomes, correlates and alternative indications or endpoints.
Preparation for and participation in scientific advisory meetings and regulatory correspondence with agencies such as FDA, EMA and MHRA.
End-to-end project management for clinical programs including site selection, feasibility and implementation oversight.
Consultancy for trial design, documentation and operational implementation in infectious disease clinical development.
Advice on design, execution and analysis of human challenge trials and challenge agent use, from protocol through to clinical study report.
Support for the design, execution and analysis of clinical trials involving bacteriophage therapeutics.
Reanalysis of trial data to identify significant outcomes, correlates and alternative indications or endpoints.
Preparation for and participation in scientific advisory meetings and regulatory correspondence with agencies such as FDA, EMA and MHRA.
End-to-end project management for clinical programs including site selection, feasibility and implementation oversight.
Expertise Areas
- Clinical trial management
- Controlled human infection models (CHIM) / Human challenge trials
- Regulatory strategy and agency engagement
- Clinical data analysis and biostatistics
Key Technologies
- Controlled human infection models (CHIM)
- Human challenge trial design
- Clinical protocol and synopsis development
- Statistical analysis for clinical trials
News & Updates
Delivered a full-service design and implementation package for a therapeutics developer targeting infections associated with diabetic foot ulcers, including refocusing indication, documentation (synopsis, protocol, regulatory package), additional preclinical studies and multi-country trial planning.
Statistical reanalysis of an intranasal antiviral trial identified significant correlates and enabled retargeting the product, contributing to positive stock market announcements for the sponsor.
Advised a vaccine company to use a human challenge trial to obtain early phase 2 efficacy data for a cholera vaccine, prepared US development strategy and assisted with FDA meeting preparation and site selection for the trial.
Performed scientific assessment and gap analysis that defined a clear path forward to initiate phase 2 efficacy trials in the US and EU for a marketed antiviral product.
Delivered a full-service design and implementation package for a therapeutics developer targeting infections associated with diabetic foot ulcers, including refocusing indication, documentation (synopsis, protocol, regulatory package), additional preclinical studies and multi-country trial planning.
Statistical reanalysis of an intranasal antiviral trial identified significant correlates and enabled retargeting the product, contributing to positive stock market announcements for the sponsor.
Advised a vaccine company to use a human challenge trial to obtain early phase 2 efficacy data for a cholera vaccine, prepared US development strategy and assisted with FDA meeting preparation and site selection for the trial.
Performed scientific assessment and gap analysis that defined a clear path forward to initiate phase 2 efficacy trials in the US and EU for a marketed antiviral product.