Clinical Pharmacology Areas of Support

Data Management

  • Adverse Event Collection
  • Safety Tables
  • Statistical Analysis

Medical Writing

  • Integrated Pharmacokinetic and Safety Reports
  • Manuscripts and Presentations
  • Regulatory Documents

Study Initiation

  • Identify Phase 1 Clinical sites
  • Manage Site Communication
  • Site Monitoring
  • Investigator Meetings

Clinical Pharmacology Program Development

  • First‐in‐Human Studies
  • PK/PD & Dose Escalation
  • Drug‐Drug Interactions
  • Food Effect
  • Special Populations
  • Comparability and/or Bioequivalence Studies
  • Proof of Concept Studies

Design & Protocol Development

  • Investigator’s Brochure
  • CRF Design
  • Protocol Design
  • Analysis plans
  • Bioanalytical Validation Oversight

Pharmacokinetics and Pharmacodynamics Analysis and Modeling

  • Review of Bioanalytical Data
  • Non‐Compartmental Analysis
  • Bioequivalence Testing
  • Statistical Analysis
  • PK/PD Modeling and Simulation
  • Population Analysis
  • In Vivo/In Vitro Correlations
  • Optimal Design
  • Training of Personnel for PK