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 |














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