Excellence in Ethical Clinical Trials

• Study Management: Comprehensive oversight from initiation to closeout
• Protocol Development: Expert protocol design and optimization
• Medical Monitoring: 24/7 medical oversight and safety monitoring
• Site Coordination: Efficient site management and communication
• Quality Assurance: Rigorous quality control and compliance
• Data Management: Accurate data collection and validation

• Protocol Writing: FDA/EMA compliant protocol development
• DSUR/PSUR/PBRER: Periodic safety update reports
• Medical Writing: Clinical study reports and documentation
• Safety Vigilance: Adverse event monitoring and reporting
• Regulatory Submissions: IND, NDA, and international submissions
• Quality Assurance: Regulatory compliance and audit support

• EC Formation: Assistance in establishing ethics committees
• SOP Development: Standard operating procedures creation
• Committee Composition: Expert guidance on member selection
• Review Process: Streamlined protocol and document review
• Participant Protection: Ensuring rights, safety, and well-being
• Compliance: Adherence to ICH-GCP and local regulations

We provide comprehensive training programs to students of:

• B. Pharm (Bachelor of Pharmacy)
• Bio Tech (Biotechnology)
• Pharma D (Doctor of Pharmacy)
• Other interested candidates in Clinical Research

Training Modules Offered:

• Clinical Research: Comprehensive training on clinical trial design, conduct, and management
• Pharmacovigilance: Drug safety monitoring, adverse event reporting, and risk management
• Clinical Data Management: Data collection, validation, and database management
• Regulatory Affairs: Regulatory submissions, compliance, and documentation

All modules are delivered by experienced mentors with extensive industry expertise, ensuring practical, hands-on learning experiences.

• Operational Support: Managing day-to-day site activities including patient recruitment, screening, and retention strategies, while ensuring accurate and complete data collection, entry, and management to ensure the trial runs smoothly
• Investigator Selection: Qualified investigator recruitment and onboarding
• Site Initiation: Efficient site setup and training
• Ongoing Monitoring: Regular site visits and quality checks
• Quality Assurance: Compliance monitoring and audit support
• Site Closeout: Systematic site closure and documentation

• Master Data Management: Centralized data repository management
• Reference Data: Standardized reference data maintenance
• Data Quality: Comprehensive data validation and quality checks
• Auto Reconciliation: Automated data matching and reconciliation
• Monitoring: Continuous data monitoring and discrepancy resolution
• Reporting: Real-time data quality reports and analytics