Pharmacokinetics & Statistics
- Study design, pharmacokinetic and statistical inputs (SAP) in
protocol preparation. - Sample size determination in BA/BE & clinical trials.
Pharmacokinetic, pharmacodynamic analysis and Statistical
evaluation in BA/BE studies & Clinical trials using WinNonlin
and SAS® software. - Study reports as per regulatory requirement & in eCTD format.
Clinical Data Management
- CRF Designing, printing & distribution
- Database setup
- Data Processing/ Delivery
- Coding
- External data Reconciliation
- Quality Reviews
- Trainings
Our Application
- Clinical Data Management System (CDMS)
SAS PheedIT, Any Sponsor specific application on ASP Model
Coding Dictionary
- MedDRA, WHODD, Any sponsor specific coding dictionary
CRF Designing
- Adobe Frame Maker
