An East Coast clinical research organization with a network in India to facilitate clinical trials for U.S.-based pharmaceutical and biotechnology companies is raising $1.2 million as the number of clinical trials in India is set to grow.
IndiPharm, based in Wayne, Pennsylvania, has clinical operations in Mumbai, India, through its regional subsidiary. Last year, IndiPharm, with its subsidiary, launched a clinical research headquarters in Powai in Mumbai. The larger site was designed to support an expansion of its core staff with project management, clinical monitoring and data management personnel. In December, it hired a vice president to head up pharmacovigilance from Pfizer.
Among the services the company provides are conducting proof-of-concept studies along with mid- to late-stage clinical trials, medical monitoring and site monitoring, coordinating central lab logistics, statistical programming and biostatistics. It also can identify local investigators for clinical trials, according to its website.
There are approximately 1,891 clinical trials under way in India, according to the clinicaltrials.gov website.
With research and development costs spanning several years before drugs are approved, emerging markets have become increasingly attractive for drug developers as a way to reduce expenses. Although there has been some criticism over clinical trial oversight in the country, there has been a push for reform.
Offshoring for clinical trials was expected to grow in India. A 2008 study estimated that India would account for 15 percent of global clinical trials. The country represents a significant pharmaceutical market in its own right, currently valued at $8.4 billion but is estimated to nearly double to $16.5 billion by 2014, according to a recent Ernst & Young report.