Seasoned Clinical Researcher || Medical Writer || Corporate Trainer 

I am a Clinical Research Professional having 10+ years of hands-on experience in Medical Writing & Global Clinical Trial Project Management. I have extensive experience in medical writing for clinical study protocols, case report forms, investigator's brochures, clinical study reports, and associated documents. During my journey as an employee, I have actively participated and was involved in clinical studies of 08 New Chemical Entities, 2 New Biological Entities, 4 Bio-similar, 27 Vaccines, and 500+ BA/BE studies (including First to File projects). Having in-depth knowledge of the global regulatory process for clinical research i..e USFDA, Health Canada, EU/EMEA, MHRA, DCGI, CFDA, MCC, TGA, ANVISA, ICH, WHO etc. 

My Core expertise are 

1-Feasibility Assessment- Selecting Clinical study design, CRO/ Site Selection, Vendor Selection, Project Planning 

2-Medical Writing (Clinical Study Protocol, Clinical Study Report, SOPs writing, Investigator brochure, Informed consent Document, Patient Dairy, Case report form) based on the different regulatory requirements. 

3-Aggregate Report Writing- Periodic Safety Updated Report (PSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Development Safety Updated Report (DSUR), Risk Management Plan (RMP) etc. 

4-Signal Management-Signal Detection, Signal Validation & prioritization, Signal evaluation reports and track signals for products. 

5-Regulatory writing- eCTD (Module 2.4 to 2.7 preparation), Summary of Product Characteristics (SmPC), Product Information Leaflets (PIL), Product Monograph (PI) etc. 

6-Manuscript Writing 

7-Blog, Newsletter, White Paper writing 

9-Clinical Trial Design Selection 

10-Project Management 

11-Independent Clinical Monitoring & Auditing 

12-Regulatory Compliance Check 

13-Clinical Research Project Outsourcing Consulting 

14-Clinical Trial Project Management 

15-Vendor Management