Our Services
Comprehensive Clinical
Comprehensive Clinical
Research Services in India
As a leading Clinical Research Organization in India, we provide end-to-end CRO services from study design through regulatory submission.
Clinical Operations
End-to-end trial execution with GCP compliance, site management, and monitoring across India.
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Project Management
Expert coordination of complex multi-site trials with strict timelines and sponsor communication.
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Pharmacovigilance
SAE reporting, signal detection, safety monitoring, and CTD Module II preparation.
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Regulatory Affairs
IND, NDA, ANDA submissions for CDSCO, FDA, EMA, and other global regulatory agencies.
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Data Management
99.9%+ accuracy data management with EDC, CDISC compliance, and rigorous QC throughout.
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Medical Writing
Protocols, CSRs, IBs, DSURs, and regulatory manuscripts for global submissions.
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BABE Services
Bioavailability/Bioequivalence study support including regulatory submissions and site management.
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Statistical Analysis
ICH E9-compliant biostatistics, SAP development, randomization systems, PK/PD analysis, and final analysis reports for regulatory submissions.
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Quality Assurance
GCP audits, SOP development, CAPA management, regulatory inspection readiness, and quality management systems for clinical trial compliance.
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