Clinical Operation Services
Our Clinical Operations team is experienced in managing clinical trials of varied sizes and complexity in different therapeutic areas like Infectious Diseases, Oncology, Cardiology, Gastroenterology, Nephrology, Diabetes, Obstetrics & Gynaecology, Urology, Pain Management, Dermatology, Ophthalmology, Neurology, Psychiatry, and Parenteral nutrition. Our team has executed many NDA, ANDA, and Biosimilar products clinical development programs including vaccines. The team comprises people with the right attitude, flexibility, reliability, and commitment to 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 executive-level experience in most Asia Pacific countries like the 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 closeout.
Our Clinical Research Development associates are trained and experienced to evaluate and enhance vendor and site performance. Our project managers are fine-tuned for the 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 utilized for Phase I to IV clinical trials including proof of concept study. We are specialized in managing the following Clinical Operation Development 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
- Archival
Phase I
The third Phase trials aimed at being the definitive assessment of how effective the drug is, in assessment with current 'gold standard' treatment. They are designed to assess the effectiveness of the new intervention, and thereby, it’s valued in clinical practice.
Phase II
The second Phase trials are generally performed on larger groups. They are deliberated for the assessment of biological activity of drug, as well as safety assessments in a larger group of volunteers and patients.
Phase III
The third Phase trials aimed at being the definitive assessment of how effective the drug is, in assessment with current 'gold standard' treatment. They are designed to assess the effectiveness of the new intervention, and thereby, it’s valued in clinical practice.