Driving Success in Every Clinical Trial
Behind every successful clinical trial is a well-coordinated engine — and that’s where we come in. Clinical Operations is more than a function; it’s a commitment to precision, proactive planning, and seamless execution.
Why This Service Matters
Whether you’re leading a single-site Phase I study or a global, multi-center Phase III or IV trial — including Real-World Evidence (RWE) studies — we deliver flexible, sponsor-aligned Clinical Operations solutions to keep your trial progressing with confidence.
Our Key Capabilities
End-to-end clinical trial management you can trust
📋 Study Startup & Feasibility
- Country and site selection
- Site qualification visits (SQVs)
- Regulatory & Ethics submissions
- Essential document management
- Site contract & budget negotiation
🏢 Site Management & Monitoring
- Site initiation and training
- On-site & remote monitoring
- Source data verification (SDV)
- Query management & resolution
- Visit reports and follow-ups
🧠 Clinical Project Management
- Project plan development
- Timeline and milestone tracking
- Vendor and CRO coordination
- Risk management & escalation
- Real-time reporting and communications
📦 Trial Closeout & Audit Readiness
- Site closeout visits
- Final TMF reconciliation
- Archiving and audit prep
- Closeout reports and insights
🩺 Therapeutic Area Expertise
- Oncology
- CNS & Psychiatry
- Infectious Diseases
- Cardiometabolic Disorders
- Rare & Orphan Diseases
👥 Flexible Resourcing with FSP
- Clinical Project Managers
- Regional or National CRAs
- Clinical Trial Assistants & Document Specialists
- Regulatory Coordinators
1 Comment
mayur
Hello, can we connect for a new study?