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Promedica International (PMI) and Dr. Agarwal’s Eye Hospitals (AEH) have formed a new partnership to conduct clinical trials in India, which they announced at the OCTANe Ophthalmology Technology Summit. PMI and AEH emphasized that this alliance will enable them to collaboratively enroll and manage clinical studies in an expanded patient population, while conforming with global and FDA qualification standards and regulations.
PMI, as a professional contract research organization based in the US, will lead in the design of studies that meet or exceed global Good Clinical Practice and medical quality standards. AEH, which is an international ophthalmic healthcare system, will provide clinical expertise and facility access in India.
With its extensive background in clinical research, PMI offers services that include project management, study management and monitoring, data management, statistical services, clinical quality assurance, medical writing and global regulatory support.
“For PMI, this partnership will initially augment our resources for enrollment and management of FDA clinical trials. At the same time, AEH gains the opportunity to significantly improve their quality and volume of clinical research with timely execution of studies,” said Shannon Stoddard, President/CEO of PMI. “Over the longer term, we believe this collaboration will enable both parties to build a global organization for conducting ophthalmic studies, and foster the development of proprietary models for multiple disease states,” said Ms. Stoddard.
“AEH and PMI are a winning combination because we share complementary goals and a vision of how to best deliver on the promise of clinical research,” said Dr. Ashvin Agarwal, Executive Director, Chief of Clinical Services at AEH. “Dr. Agarwal’s Eye Hospitals welcomes the opportunity to work with PMI because of their success and the brand they have built performing their clinical study services on a global level.”