Services
All services(3)
All services(9)
Clinical Trial Insurance Management
Regulatory Consulting
Obtaining clinical trial approval (CTA)
US FDA regulatory support
Ethics Committee and Institutional Review Board (IRB) support
Import and export licenses
Translations and Adaptations
Amendment and Notification Submissions
Orphan Drug Designation from EMA & US FDA
All services(7)
All services(7)
All services(5)
All services(5)
All services(5)
All services(8)
All services(6)
All services(9)
All services(3)
All services(9)
All services(4)
All services(8)
All services(8)
Statistical Analysis Plan (SAP)
Sample Size Calculation
Randomization schedule development
Presentation of results in TFLs with explanatory notes
Development of interim and final statistical report
Electronic Data Transfer
SDTM, SDRG, ADaM, ADRG, CDISC compliance
Statistical data analysis and Report
All services(8)