We offer comprehensive clinical research solutions tailored to meet the diverse needs of our clients. Our integrated services span the full clinical studies, ensuring high-quality outcomes and timely project execution aligned with global regulatory standards.
Our Service Offerings Include:
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Study Design and Planning
- Clinical study design tailored to regulatory and therapeutic requirements
- Studies include Single and multiple dose studies with fasting and fed state
- PK/PD studies
- Special population studies (Eg. Post-Menopausal and geriatric studies)
- Informed Consent Form (ICF) and protocol development
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Regulatory and Ethics Approvals
- Regulatory submissions and approvals for project initiation
- Pre-study approvals from Independent Ethics Committee (IEC)/Institutional Review Board (IRB)
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Clinical Phase Execution
- Subject recruitment and management
- Full conduct of the clinical phase in compliance with GCP
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Bioanalytical Services
- Precise and validated methods for bioanalysis across multiple matrices
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Project Oversight
- Dedicated project management throughout the study
- Pre- and post-project regulatory support
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Data and Reporting
- Clinical data management using industry-standard platforms
- Biostatistical analysis and interpretation
- Medical writing and integrated clinical study report preparation
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Regulatory Submission Support
- CTD/eCTD submissions for global regulatory bodies
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Archival
- Secure storage and archival of data and study materials for future reference and audit readiness