Overview
overview test With extensive facilities and a dedicated team, the clinical research department covers a wide range of services which includes clinical trials, statistical analysis, pharmacovigilance and data management.
Key Services Include
Clinical Trial and Studies
- Phases II, III, IV Clinical Trials
- Fellow of National Board Projects
- Investigator Initiated Trials
- Clinical Registries
- Diplomate of National Board Projects
- Medical Device and Diagnostics Validation
- BABE Studies
- Protocol Development for Research Questions
Biostatistics
- Statistical Planning and Sample Size Calculation
- Develop Statistical Analysis Planning
- Support Electronic Data Transfer
- Statistical Programming and Analysis
- Interpretation of Statistical Variables
- Develop Statistical Report and Summaries
Pharmacovigilance
- Medical Monitoring
- Literature Reviews and Medical Narratives
- Assist in Filling CIOMS & PSUR’s
- Signal Detection and Trend Analysis
Data Management
- In-House Database & Study Setup
- PV, PK & PD Services
- Database Design and Study Setup
- Clinical Trial Data Entry and Validation
- Electronic Source Documentation
- Query Handling and Resolution
- Support Study Team for Efficient Handling of Database Lock