Mission
To accelerate clinical development through ethical, compliant, and high‑quality site management practices.
Reliable Clinical Trial Execution in India
Citius CRS partners with global and Indian Sponsors and CROs to deliver compliant, structured, and inspection‑ready clinical trial execution across Western India.
Our operational model is built on regulatory discipline, documentation integrity, and performance‑driven site management—ensuring predictable, high‑quality outcomes at the site level.
- Regulatory‑compliant
- Audit‑ready
- Performance‑driven
Our Performance Snapshot
- 50+ Clinical Studies delivered and ongoing
- Phase II–IV and BA/BE experience
- 100% Regulatory Submission compliance
- USFDA inspection cleared — No Action Indicated (associated site)
Who We Are
Established in 2021, Citius CRS operates as a dedicated Site Management Organization (SMO) across Pune and Nashik, Maharashtra, India.
Vision
To be a trusted, inspection‑ready SMO recognized for precision, integrity, and operational excellence.
Operating Principles
- Regulatory compliance
- Operational efficiency
- Scientific integrity
- Inspection readiness
End‑to‑End Site Management
We support Sponsors and CROs across the complete clinical trial lifecycle at the site level.
Clinical Trial Phases
- Phase I
- Phase II
- Phase III
- Phase IV
- BA/BE Studies
Start‑Up Support
- Feasibility assessment
- Site selection & activation
- Regulatory submissions
- Ethics Committee coordination
Recruitment & Conduct
- Structured recruitment & retention
- Protocol‑compliant execution
- Safety oversight
- Data accuracy monitoring
Documentation & TMF Control
- Contemporaneous documentation
- Essential document maintenance
- Audit‑ready TMF oversight
Audit & Inspection Support
- Pre‑inspection review
- Documentation reconciliation
- Sponsor/regulatory inspection assistance
Quality, Ethics & Governance
Patient safety, ethical conduct, and data integrity are non‑negotiable pillars of our operations.
Regulatory Alignment
- ICH‑GCP (E6 R2/R3)
- NDCT Rules 2019 (India)
- CDSCO requirements
- Sponsor‑specific SOPs
Ethics & Patient Safety
- Independent Ethics Committee oversight
- Informed consent integrity
- Confidentiality assurance
- Transparent audit trails & continuous quality monitoring
Therapeutic Experience
Broad coverage supports diversified recruitment strategies while maintaining protocol adherence and high data integrity.
Oncology & Urology
Endocrinology & Psychiatry
Dermatology & Gastroenterology
General Medicine & Pediatrics
Gynecology & Neurology
Cardiology & Orthopedics
Nephrology & Ophthalmology
Pulmonology
Contact
Send us a message. We’ll get back within 1–2 business days.
Reach Us
Email: citiuscrs@gmail.com
Phone: +91 9860090238
Locations: Pune & Nashik, Maharashtra, India