RESEARCH & DEVELOPMENT
Clinical trials conducted after the drug is marketed (Phase 4 studies) are an important source of information on yet to be detected adverse outcomes, especially in some segments of populations that may not have been involved the premarketing trials (e.g., children, the elderly, pregnant women) and the drug's long-term morbidity and mortality profile. Regulatory authorities sometimes require companies to conduct Phase 4 studies as a condition for market approval.
At Ambrosia, we offer end to end services for clients interested in conducting post marketing studies, begining from the Essential documents preparation, Ethics Committee coordination, Site selection, Trainings, Monitoring, Data Collection & Analysis, and Clinical Study report generation Ambrosia offers a one stop solution.
Ambrosia also is in the forefront of innovative Electronic Data Capture technology to be implemented in collecting data from the post marketing studies as most of the PMS is conducted on large patient population and most of the logistical burden and cost can be avoided using an effective tested EDC solution.
Ambrosia also helps in maintaining Registries for various therapeutic indications in order to help the Investigators in their continuous effort to explore innovative therapies.
Ambrosia is currently engaged with leading Phamaceutical companies with their blockbuster products in conducting Post Marketing Studies across various parts of India.