- SOPs preparation for Sponsor
- CRO site identification
- Budget and Timeline tracking
- Study synopsis preparation (with proper study design, number of subjects, PK sample time points, Inclusion and exclusion criteria, wash out period etc.)
- Protocol review, ICF, DCGI application documents review support
- DCGI queries support
- Biostudy insurance support (Risk calculation and quote request)
- IMP shipment support (preparation of labels, shipping documents, data logger calibration records, temperature records)
- Monitoring of study at each phase
- Risk mitigation and ongoing assessment
- Study report review