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.
Pharmacometrics is defined as the science that quantifies drug, disease and trial information to aid efficient drug development and/or regulatory decisions. Drug models describe the relationship between exposure (or pharmacokinetics), response (or pharmacodynamics) for both desired and undesired effects, and individual patient characteristics. Disease models address the relationship between biomarkers and clinical outcomes, time course of disease and placebo effects. Trial models capture the inclusion/exclusion criteria, patient discontinuation and adherence, and are the central piece of clinical trial simulations.
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.
You contact us by email or by phone.
We review your project and scientific background information.
We create a detailed project proposal, tailored to your needs.
Calvagone was established by Christian Laveille in 2015, quickly attracting a team of skilled consultants. As of February 2024, leadership has transitioned to Emilie, Andreas, and Erno, marking a new chapter in our growth story.
Our defining traits are our enthusiasm, flexibility, profound expertise, and a commitment to building lasting relationships with our customers.
We are proud to have been recognized with the Crédit Impôt Recherche (CIR) accreditation by the French Ministère de la Recherche for three consecutive periods: 2017-2020, 2020-2022, and now 2022-2025. This accreditation underscores our commitment to fostering R&D partnerships and advancing scientific exploration.
The first thing to do is to put a mutual non-disclosure-agreement in place using either your or our own template.
Every project is unique and highly customized. Please contact us for a detailed proposal. Note, we do offer discounts for new clients.
It depends, we usually prefer to define a milestone-based quotation, where each milestone is clearly described regarding timelines and costs. There are no hidden costs. However, for general consulting projects, we invoice based on the time spent.
We are working from home, and are located in France, in the Netherlands, in Spain, in Belgium, in Germany and in Finland. The official address is in France (see our contact details).
Yes, we have set-up a high-performance computing server, which is hosted near Lyon in a dedicated datacentre. We have already run some very complex PK/PD models in a reasonable time.
Yes, we have SOPs for the key aspects of our work. As we are working from home, it is really important to have standardization in order to achieve efficiency and uniformity of performance.
Yes, we obtained in April 2017 the accreditation for Crédit Impôt Recherches (CIR) from the French « Ministère de la Recherche » for a three-year period. This accreditation has been renewed in 2020 and in 2022, presently active until 2025.