Tripha Life Sciences conduct clinical research according to established guidelines for Good Clinical Practices as provided by International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). We also conduct research in compliance with other applicable regulatory requirements as defined by the Food and Drug Administration (FDA)
As an independent and multi-therapeutic clinical research site we are involved in all aspect of site management from initiation to closeout of clinical trials. This includes:
- Matching PI with studies
- Study and sponsor search
- Site compliance and preparation for initial visit
- SOP design.
- Regulatory documents preparation and submission to IRB/sponsor
- Contract and budget negotiation.
- Patient recruitment and enrollment
- Clinical data entry and managements
- Adverse events reporting