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Project Management
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Clinical Operations
Since 1997, iGate Clinical Research has provided Clinical Operations and Site Management services handling trials with both paper-based and electronic data capture across phase I - IV. Most trials have been part of global drug development programs for US FDA and EMEA submission.
iGate's systems and standard operating processes have been audited over 40 times. Our auditors have included global quality assurance teams from five of the top 20 pharma companies. Repeat business from our existing customers is driven by our service delivery standards and our industry-leading monitoring and data quality metrics.The comprehensive range of services offered by the clinical operations group includes:
- Protocol feasibility analysis
- Project governance plans and project status tracking reports
- Negotiations and finalization of study contracts
- Risk management and mitigation strategy
- Resource allocation and performance management
- Site evaluation and selection
- Investigator team training
- Clinical monitoring (source data verification, ICD review, SAE reporting, drug accountability, inventory management)
- Query resolution and database lock
- Site close out and archival of data
- Quality assurance and site audits
- Compilation and submission of Clinical Trial Application to Drugs Controller General of India (DCGI)
- Completion of Investigator Undertakings (equivalent to FDA form 1572)
- T-license application for import of trial supplies
- Application to Director General of Foreign Trade (DGFT) for sample export license
- Follow-up on the status of applications
- Clarifications and supportive documents as applicable
- Submissions of protocol amendments, safety mailings, study status reports as required
- Import and clearance of study drug
- Facilities and infrastructure support for clinical trial supply storage
- Packaging and distribution of drugs to sites under temperature-controlled and protocol-specified conditions
- Monitoring and documentation as per regulatory and audit requirements
For more about our capabilities, please request our "Clinical Operations and Site Management Fact Sheet"
