At Insight Medical, we offer comprehensive clinical operations support that guarantees the compliance, integrity, and efficiency of your clinical trials. From site selection to close-out, our experienced team ensures that every phase runs smoothly and adheres to the highest GCP standards.
Clinical Operations
Ensuring the Compliance and Integrity of Your Clinical Trial
Our Clinical Operations Services
- Program & Project Management
Our expert team oversees your clinical programs and projects, ensuring that timelines, budgets, and quality metrics are consistently met. - Site Management
We handle every step of site management, from site selection and qualification to initiation, start-up, enrollment and then close-out, ensuring sites perform at their best. - Clinical Monitoring
Full-service clinical monitoring to ensure protocol adherence, patient safety, and data accuracy throughout the trial. - Trial Master File (TMF) Management
We develop, maintain, and manage your Trial Master File in line with regulatory requirements and industry best practices.
- Safety Management
Comprehensive safety services, including:- Adverse Event (AE) Review
- Patient Narrative Development
- Medical Coding
- Medical Monitoring
- Regulatory Safety Reporting
- Oversight of Safety Committees (e.g., CEC, DSMB, SRC)
- Data Management
Robust data management services including:- CRF Design
- Database Build and Validation
- User Acceptance Testing (UAT)
- Data Cleaning and Analytics
- Biostatistics Services
We provide statistical support, including:- SAP Development
- Randomization Schema
- TFL Shell Development
- Statistical Analysis and Interpretation
- Study Rescue Services
If your study is facing challenges, we offer expert “study rescue” services to get your trial back on track quickly and efficiently.
