Clinical Operations
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Clinical Operations
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CLINICAL OPERATIONS
Our Clinical Operations team is experienced in managing clinical trials of varied size and complexity in different therapeutic areas like Infectious Diseases, Oncology, Cardiology, Gastroenterology, Nephrology, Diabetes, Obstetrics & Gynaecology, Urology, Pain Management, Dermatology, Ophthalmology, Neurology, Psychiatry and Parental nutrition.
Our team has executed many NDA, ANDA and Biosimilar products clinical development programs including vaccines. The team comprise of people with the right attitude, flexibility, reliability and commitment for excellence.
Our clinical research associates are trained and experienced to evaluate and enhance vendor and sites performance. Our project managers are fine tuned for planning of all project related activities and communication. These characteristics enable them to comfortably manage the risks and challenges that come during clinical trial execution.
We are specialised in managing the following Clinical Operation activities:
- Patient Recruitment and Retention
- Site Monitoring
- Site Close Out
- Trial Master File Management
- Archival
- Site Initiation
- Project Management
- Study Feasibilities
- Site Evaluation and Selection.
- Vendor Selection and Management
- Ethics Committee Submission
- Contract Execution