In Phase I / Bioequivalence

PharmaNet offers a comprehensive range of clinical development and consulting services for early stage programs, including Phase I and bioequivalence studies. PharmaNet conducts early stage programs for international sponsors through our global network of resources.

Phase I / Bioequivalence Services
Pharmaceutical Development Services
Protocol writing and study design
Case Report Form design
Institutional Review Board submissions
Regulatory submissions (IND, CTA, NDA, BLA)
Recruiting of healthy subjects and special populations
Phenotyping/genotyping studies
Phase I-IIa/bioequivalence clinical trials
QT/QTc studies
Clinical laboratory
Adverse event coding and reporting
Data management
Drug and metabolite assay development
Drug analysis in biological matrices
Biostatistics, pharmacokinetic and pharmacodynamic modeling and reporting
Clinical trial reports
Electronic data submission and electronic reports

PharmaNet Development Group, Inc.504 Carnegie Center, Princeton, NJ 08540Tel 609 951 6800Fax 609 514 0390