Clinical Research Services
Clinical Trial Management (Phase I*– IV clinical trials)
Study Feasibility
Regulatory Approvals
Site Identification & Initiation
Investigator Recruitment & Training
Patient Enrolment Medical & Site Monitoring
Site Audits & Quality Assurance
Study Close-out
Clinical Data Management
Database Design & Validation
Data Entry & Verification
Medical Coding
Discrepancy Management
SAE Reconciliation
CTD/eCTD Submissions using KnowledgeNet & Liquent
Bio-Statistics
Statistical Analysis Plan
Sample Size Calculation
Randomization Schedule
CRF Annotation
Interim Statistical Analysis
Final Statistical Analysis
Analytical & Reporting Services
Medical Writing
Protocol DesignCRF Design
ICF Design
Investigator Brochure
Clinical Study Report (CSR)
Medical Manuscripts
ANDA Submissions Documentation
NDA Submissions Documentation
Safety & SAE Narratives
Other Clinical Services
Bio-Analytical Services
Pre-Clinical Services
Central Lab Services
Pharmacovigilance Services
Core ECG Services
Corporate Clinical Training Programs
CRA In-sourcing
Regulatory Consulting
Regulatory Strategy for innovator products, generic products and medical devices
Regulatory Submissions and Approvals for US FDA, EU MHRA, India DCGI and other markets
Regulatory Compliance Consulting
Regulatory Audits Consulting