George Clinical has recently been awarded the contract for full service clinical trial management services for a clinical study that seeks to improve the formulation further and also the current administration challenges for a rotavirus vaccine.
The vaccine was recently launched by Indian Prime Minister Narendra Modi and developed by a Hyderabad based healthcare organization marketing vaccines and bio-therapeutics. It is the first vaccine wholly developed in India. In India, it is estimated that almost every child would have an episode of rotavirus gastroenteritis by the age of 5. Globally, rotavirus causes over 500,000 deaths a year, particularly in emerging countries.
Development of the vaccine was supported by India’s Department of Biotechnology, the Bill & Melinda Gates Foundation, the Research Council of Norway, and the UK Department of International Development.
Currently, the vaccine has to be kept frozen at -20°. This causes practical challenges in the field and limits the applicability of the vaccine in emerging countries where rotavirus causes the most damage. George Clinical will implement a clinical trial that compares the safety and efficacy of a new generation of this vaccine to the original formulation. The new generation vaccine can be refrigerated.
The services provided by George Clinical includes Project Management, Clinical Monitoring, Pharmacovigilance, Data Management, Statistics and Medical Writing. Most of these services will be supported by George Clinical’s on the ground personnel in Hyderabad and Bangalore. George Clinical was successful in its bid for this contract based on a competitive quote, its reputation as a high quality provider, and its bespoke solutions that focuses on the customer.
“Like our partner in research, The George Institute, we are committed to supporting low cost, practical solutions yet still deliver high quality services in a timely fashion”, says Gopal Pai, General Manager of George Clinical’s operations in India. “Personally, I’m proud to be supporting our nations’ ‘Make in India’ campaign by implementing the Sponsors clinical trial.” ‘Make in India’ is Prime Minister Narendra Modi’s flagship campaign to put the country prominently on the global manufacturing map.
Currently, the recruitment for the first phase has completed 1.5 weeks ahead of time, achieving 675 subjects across 9 sites. There was seamless coordination of activities within the George Clinical team and the sponsor, resulting in the project moving forward rapidly.
George Clinical’s Chief Executive Officer, Dr Marisa Petersen is pleased as well. “India has been a core country for our clinical trial services for 7 years, as well as being a leader in The George Institute’s public health activities for 15 years. Supporting one of the leading biotech companies in India on this study which will have immediate impact on India’s children is very satisfying.
The clinical trial is expected to commence its second phase, in late 2015 and complete in the latter half of 2016, with results available in late 2016.