Overview of Typical Tasks and Deliverables :
Clinical Research
 
Clinical trial management
Patient Recruitment and Retention
Onsite monitoring
Final data review and preparation of clinical study reports
Pharmacovigilence
   
Data Management
 
All elements of data flow process (e.g., case report form development, validation checks, data listing review, statistics)
   
Regulatory Documents
 
Strategy
Esubmissions
Submissions
Interactions
   
Medical Writing
 
Investigator Brochure
Protocol
Case Report Form
Patient information leaflets for clinical trials and package inserts
Informed Consent Form
Safety data reports
Statistical analysis plan
Medical translation services
Regulatory submissions
Final Report
   
 
Design : Pruthvi Cybertech