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Consulting and training
for your clinical development

References

Since our creation in 2000, more than 40 companies have requested our services, from the largest pharmaceutical companies, to emergent, dynamic biotechnology companies.

Clinical development services

The services we have provided so far range from data analysis and/or simulation of phases I to IV trials to CTD writing. We have contributed to more than 50 drug development programs with regulatory documents. We contributed to several NDA submissions and designed proof-of-concept studies using Modeling & Simulation that have been successful for our clients.

The establishment of long-term partnerships to accompany drug development while providing company support for personnel development in the area of PK/PD Modeling & Simulation is our recognized trademark.

Many therapeutic areas using M&S

We have analyzed and reported more than 300 studies, in most therapeutic areas: CNS (stroke, MS, pain, anxiety, depression, Parkinson’s disease, sleep, epilepsy, migraine) , cardiovascular ( CHF, PAH, HTA), erectile dysfunction, BPA, coagulation, inflammation, GI, endocrinology, metabolic, renal (nocturia), allergy, dermatology, respiratory, cancer, osteoporosis, and infectious diseases.

Of course, the development of all these projects has been optimized by the use of Modeling & Simulation making them efficient each in their respective specialties.

Our trainees

Since the beginning of the use of pharmacometrics in clinical development, we have trained clinical scientists, mainly in the area of pharmacokinetics and pharmacodynamics for drug development. They are pharmacometricians, statisticians, kineticists, regulatory affairs personnel, monitors, bioanalysts, project leaders, clinical pharmacologists, etc. Thanks to our workshops, all our trainees have been able to conduct their own project with all the competences they needed.