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 team shares the same understanding of standard operating procedures and regional operational requirements to facilitate Phase I to IV clinical trials including proof of concept study. Our current Operations team has a combined experience of 40 plus years. We have execution level experience in most of Asia Pacific countries like Philippines, Malaysia, Indonesia, Sri Lanka and Bangladesh. Our team has managed studies as small as 24 patients (phase I study) to 100000 patients (cluster base large community) study where we have managed all the activities from initial set up to study close out.
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.
Our operational expertise can be utilised for Phase I to IV clinical trials including proof of concept study. We are specialised in managing the following Clinical Operation activities:
- Project Management
- Study Feasibilities
- Site Evaluation and Selection.
- Vendor Selection and Management
- Ethics Committee Submission and Contract Execution
- Site Initiation
- Patient Recruitment and Retention
- Site Monitoring
- Site Close Out
- Trial Master File Management