Phase I & IV Services
Azidus has experienced team of professionals to handle the all phases of drug development from Phase I to Phase IV clinical trials. The technical team can design and execute the phase trials at committed time as per the current International regulatory guidelines.
Azidus provides the following trial related activities:
- Study feasibility assessment
- Investigator and site selection
- Pre-study monitoring visit
- Site management activities
- Patient recruitment and retention activities
- Calculation of Maximum Recommended starting dose (MRSD) by considering NOAEL, LOAEL & MABEL
- Dose escalations adopting simple dose escalation, Modified Fibonacci method
- Preparation of Protocol
- Preparation of Investigator’s Brochure
- Preparation of Investigational Medicinal Product Dossiers
- Project Management
- Safety reporting
- Clinical Data management
- Study report preparation
Azidus has experienced CRAs, senior CRAs, Site co-ordinators in the team for clinical trial management. Azidus has Experienced and Regulatory audited Investigators in most of the therapeutic specialties including Cardiology, Diabetology, Neurology, Gastroenterology, Rheumatology, Endocrinology, Psychiatry, Dermatology, Oncology, etc., in the Investigator’s data base.