Ciruelo No. 19 Col. Ciudad Jardin, Del. Coyoacan, C.P. 04370. México, D.F. +52 (55) 5689-4390


Therapeutic
Expertise

Our experience and resources in Latin America give us the tools to help our customers conduct quality, cost-efficient trials. We have conducted Phase I to Phase IV clinical trials in seventeen therapeutic areas for drugs, biologics, biosimilars, medical devices and cell therapy. Our team will make certain that we provide the most effective study design and the appropriate sites to get the results our customers expect.

We offer broad clinical trial experience in the following therapeutic areas:

Departments

The route of administration -oral, intravenous or inhaled- is determinant for study design in this area is. Our experience conducting clinical trials is in surgical procedural anesthesia where patient management and study logistics need to be perfectly planned and managed to run a successful trial.
We have extensive experience conducting hypertension, heart failure and pulmonary vascular disease. We have strong relationships with leading investigators from private hospitals and national institutes..
One of the therapeutic areas were we have the most expertise, in both adults and children. We have a thorough understanding of all the clinical and operational challenges associated to running CNS trials. We have ample experience in multiple sclerosis, epilepsy (adults and children), and genetic disorders.
We have experience conducting medical dermatology trials in all phases (Phase I, II and III) as well as post approval REMS for a wide range of indications, such as athlete’s foot, psoriasis and different types of dermatitis.
We have successfully conducted trials and obtained marketing approvals for a dozen medical devices across the continent for different therapeutic areas such as orthopedics, respiratory and ophthalmology.
With more than 10 years conducting endocrine/metabolic studies ranging from pre-clinical to phase III. From small molecules to combination (biologic/device) products we have been able to overcome all challenges.
Some of the challenges are with the protocol design due many diseases is related with dietary; some of the areas of expertise are IR, Gastritis, etc.
Many of the protocols were related with transmissible disease (VIH), inflammation, and infectious agents that gave to us experience with communications, the way that we communicate really matter on the area, some other like psoriasis are more common, but it was a challenge due the diagnosis and the measures (basal vs. end of the study).
We have successfully conducted phase III trials for allergic rhinitis and ear infections.
Our experience in oncology, specifically of rare types, has given us the knowledge, tools and relationships needed to design trials that meet all clinical and regulatory requirements.


It is one of our strongest areas of expertise. We have conducted trials for a wide array of indications. Ophthalmology, just as other therapeutic areas presents unique challenges due to drug combinations, route of administration and pharmaceutical form.
We have the experience doing clinical with some orthopedic devices, studies included shoes, athletes foot, fungi, and others.
Pediatric clinical trials are unique and very challenging and require specific planning. We understand and have experience planning strategic regulatory and operational strategies to ensure that the trial is executed with success.
We have significant experience conducting clinical research for respiratory/allergy drugs and devices. Our main expertise is in asthma and COPD.
We have conducted successful phase III studies in two key indications: rheumatoid arthritis and psoriasis.
Rheumatic Diseases and Sclerosis
Vaccines are unique and challenging to develop, often times requiring special logistics and special populations our experience enables us to provide solutions that will meet any vaccines development needs.
Our experience in women’s health clinical trials includes reproductive health, infertility, in vitro fertilization and labor induction.


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