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Clinical Trials
We follow robust clinical strategies for effective execution of clinical trials. We offer a wide range of services in focused therapeutic areas of Oncology, Cardiology, Dermatology, Nephrology, Neurology, Pediatrics, Gastro-entrology, Orthopedics, Gynecology.
We Provide
Clinical Operations
- Project Management
- Investigator selection and
recruitment - Clinical Trial Site Management
- Clinical Monitoring
- Medical Monitoring
Biostatistics & Programming
- Trial design & simulation
- Sample size and power calculations
- Randomization
- Statistical analysis plans
- Statistical programming
- Interpretation and reporting of data
Quality Assurance
- GCP and GLP audits
- Investigator Site Audits
- Vendor Audits
- SOP Management
- Quality Systems Training & Development
Medical Writing
- Clinical Study Report Writing
- Informed Consent Forms
- Integrated safety/efficacy
- summaries (ISS/IES)
- Submission documents
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