We are leaders of design, execution, and analysis of Bioavailability-bioequivalence and pharmacokinetic studies in Argentina

Studies

• Bioequivalence Studies
• Bioavailability Studies
• Phase I Pharmacokinetics
• Single and Multiple Dose Studies
• Replicated Designs
• PK/PD Studies
• Drug-Drug Interactions
• Food-Effect
• Pilot Studies
• In Vivo- in Vitro Correlation
• Special Populations Studies

Services

Documentation

• Design study and prep the investigative protocol
• Designing and Drafting the Informed Consent
• Designing and Preparing the Case Report Forms
• Development of Source Documents and study folders
• Clinical Documentation Management

Regulatory

• Approval management to Ethics Committees, Teaching and Regulatory Agencies

Clinical

• Execution of Investigative Study
• Selection and Recruitment of Healthy Volunteer subjects and/or Patients
• Medical, Laboratory, and Additional Exams
• Hospitalization
• Ambulatory Monitoring
• Drug Management
• Management of Source Documents and CRFs
• Collection and Processing Biological Samples
• Recording and Monitoring Adverse Effects

Bio analysis

• Quantification of Active Ingredients and Metabolites in Biological Samples

Pharmacokinetic and Statistical

• Advisory
• Sample Size Estimation
• Statistical Analysis Plan
• Randomization
• Database Design
• Data Entry
• Pharmacokinetic and Pharmacodynamic modeling
• Statistical Analysis

Drafting

• Production of Final Study Report
• Scientific Writing from the Study: Abstracts, Full-Papers, Posters

BioPharm