Calvagone
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Contact
3 allée Victor Pulliat
69380 Chazay d'Azergues
France
Director of Operations - Senior Consultant
About us
At Calvagone, we specialize in providing top-tier pharmacometrics consulting services, dedicated to supporting our clients throughout their drug development process. Our team is a diverse blend of professionals, each bringing a wealth of experience in areas such as programming, mathematics, pharmacology, pharmacometrics, and drug development.
Business offer
Calvagone provides services in: data management, non-compartmental analysis (NCA), population PK and PK/PD modelling, simulation and general clinical pharmacology and pharmacometrics consulting to support drug development.
Over the years we have gained experience in many different areas, including oncology, schizophrenia, depression, neurodegenerative diseases, infectious diseases, asthma, cardiovascular and metabolic disorders.
Our experts are skilled in pediatric drug development (PIP), orphan diseases, formulation development, bioequivalence, translational modelling, semi-mechanistic models, concentration-QT modelling, tumor-growth modelling, target-mediated drug disposition (TMDD), therapeutic drug monitoring, literature modelling, complex absorption modeling, categorical data analysis, time-to-event (survival) models, Markov models, drug-drug-interactions and PBPK.
More than 20% of our projects have been with large molecules, including bispecific antibodies and antibody drug conjugates where we frequently applied target-mediated drug disposition (TMDD) models and did first-in-human dose projections.
We are experts in clinical trial simulations with e-Campsis, our in-house developed PK/PD simulator known for its ease of use and versatility, freely accessible at www.e-campsis.com. We have a specialized service to quickly integrate and qualify PK/PD models from literature or your own files into e-Campsis, enabling prompt and reliable simulations.
Last not least, we offer customized on-site training courses in modelling with NONMEM as well as simulations with e-Campsis.
Activities
- Service
- Consulting
- Clinical trials
- Phase I
- Phase II
- Phase III
- Phase IV
- Clinical biomarkers
- Predictive biomarkers
- Treatment efficacy
- Population stratification
- Risk/benefit profile
- Disease progression / follow-up
- Safety
- PK/PD features
- Surrogate markers
- Disease progression monitoring
