Other Services
Medical Writing
- Protocol development
- Investigator brochure
- Clinical Development Plan
- Informed consent form
- Benefit/risk assessment reports
- Medical and scientific literature reviews
- Clinical study reports
Data Management
- CRF Annotation and Data Handling Manual
- Data Management Plan
- Customized Database Design & Development
- Data Entry With High Accuracy by Independent Double Data Entry
- Query Management through Computer-generated Tracked Data Clarification Forms(DCF)
- Full electronic Audit Trail
- Comprehensive Data Validation and Data Validation Reports
- Electronic Transfer (SAS Export Files)
Statistical & Programming Solution
- Sample Size and Power Calculations
- Randomization
- Statistical Analysis Plan Development
- Phase I-IV and PK/PD analysis
- Statistical Analysis Reports
- Development of validated SAS Programs
- Writing SAS Macros
- Software: WinNonlin, SAS
Quality Assurance
Regulatory
- Clinical Trial Application from Drugs Controller General (India), Ministry of Health and Family Welfare, Government of India.
- Application to import clinical trial material from Drugs Controller General (India), Ministry of Health and Family Welfare, Government of India.
- Application to export clinical study related human biological samples for their analysis from Directorate General of Foreign Trade, Ministry of Commerce, Government of India.
- Application to License for export of clinical study related human biological samples for their analysis from Joint Directorate General of Foreign Trade, Ministry of Commerce, Government of India
Pharmacovigilance
India
Chile
Malaysia
London