To Help You In Drug Development

NEW NAME, FAMILIAR FACES

Calvagone is a consulting company in pharmacometrics services that will help our clients to address their key drug development. The team is composed of people with a wide experience in different areas like; programming, mathematics, pharmacology, pharmacometrics and drug development.

What Is Pharmacometrics?

AN EVOLVING SCIENCE

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 describe the relationship between biomarkers and clinical

outcomes, time course of disease and placebo effects. The trial models describe

the inclusion/exclusion criteria, patient discontinuation and adherence.

Our Services

FROM A TO Z

Calvagone provides services in: Data Management, Non-Compartmental Analysis (NCA), population PK and PK/PD Modelling, Simulation and General Consulting to Support Drug Development.

Calvagone can support Pediatric drug development by applying scaling from Adults to Children and support the writing of the Pediatric Investigation Plan (PIP).

We have the expertise to strategize your project from early objective setting up to a concise and understandable reporting of the complex concepts and findings.

We can also provide specific courses and hands-on trainings, such as a basic and advanced NONMEM workshop.

About Us

Build Long-Term Relationships of Trust With Us

Calvagone was founded by Christian Laveille and rapidly several consultants joined the company. We are growing! What defines us: Enthusiasm, Flexibility, Solid Expertise and Keenness to Establish Long-Term Relationships.

How It Works

STEP BY STEP GUIDE

1. Contact us by email or by phone.

2. We review your project and scientific background.

3. We create a quotation to support your project.

FAQ

ANSWERS TO YOUR QUESTIONS

Q: What to do first, when we want to work with Calvagone?

A: The first thing to do is to put a mutual non-disclosure-agreement in place using either your or Calvagone template.

Q: How much do your services cost?

A: Contact us for getting a quotation on your project.

Q: Are you invoicing based on the time spent on the project?

A: 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.

Q: Where your office is located?

A: We don't have one formal office because we are working from home. People are located in France and in the Netherlands.

Q: What software do you use?

A: We primarily use NONMEM, PsN, R and SAS.

Q: Do you have the capability to run complex PK/PD models?

A: Yes, we have set-up a high performance computing server, which is hosted near Lyon in a dedicated Data Center. We have already run some very complex PK/PD models in a reasonable time.

Q: Do you have some Standard Operating Procedures in place?

A: 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.

Q: Do you have specific accreditations?

A: 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.