Our services

OUR SERVICES

Bioequivalence/Bioavailability

Design and conduct of clinical trials.
Bioequivalence/Bioavailability.
pharmacokinetic interaction of new combinations.
Design, writing, and revision of protocols.

Phase

Design and conduct of clinical trials.
clinical trials in phase I, II, III, and IV.
coordination of studies (Phase I, II, III, and IV).
Monitoring of clinical trials.
Writing, designing, and reviewing protocols.

Pharmacovigilance

Development of risk management plan (RMP).
Development of protocols for pharmacovigilance studies.
Monitoring for pharmacovigilance studies.

Monitoring

Monitoring of Bioequivalence clinical stage studies.
Monitoring of Bioequivalence analytical stage studies.
Monitoring of phase clinical studies.

OTHER SERVICES

Compliance audit with gcp’s to clinical research sites.
Training and development of procedures for clinical research sites.
Scientific consulting services.

35 +

YEARS OF EXPERIENCES

100 +

PROJECTS

35

YEARS DOING BIOEQUIVALENCE STUDIES

27

YEARS DOING PHASE STUDIES

STATISTICS FOR CLINICAL STUDIES

DATA MANAGEMENT

Statistical analysis focused on clinical studies in all phases (I, II, III, and IV).
Design of CRFs, review, and guidance for their implementation.
Specialized medical coding (WHO and MedDRA).
Proposal and SAS programming for EDIT CHECKS for plausibility (QUERIES).