Max Neeman International, a Phase I-IV contract research organisation based in New Delhi, India, has expanded its offering for medical device clients with a new team specialised in cardiac device trials, whether therapeutic, diagnostic or surgical.
According to Max Neeman, coronary artherectomy, cardiac stents, aneurysm, mitral valve regurgitation and acute coronary syndrome account for “90% of the total device trial experience”. Moreover, these are global multicentre studies enrolling as many as 300 patients apiece.
Along with prior experience of device trials, the new team and services raise the company’s game across the range of medical device studies, from the simple to the complex, Max Neeman added. It has operations and regulatory expertise in other therapeutic device segments including central nervous system diseases and ophthalmology.
India is emerging as “a destination of choice” for medical device development and clinical trials, as the market for percutaneous coronary interventions expands, Max Neeman said. The Indian device market is currently valued at US$1.7 billion and is projected to grow at 23% per year.
Among the benefits that have accelerated outsourcing of device trials to India, Max Neeman noted, are faster patient recruitment, cutting time to market by around 30%, and cost savings of 40-50%.