Indian CRO Quest Life Sciences of Chennai saw the results of a clinical trial of HIV drugs rejected by the World Health Organization after an inspection found poor clinical practices on data and bioanalytical procedures that could not be remediated, according to a letter from the Geneva-based United Nations body.
Thanks to lax regulations and legal loopholes, Indian regulators have little control over the conduct of CROs in the country, but the government is on the path to reforms that would help rein in "fly-by-night" trial operators, officials said.
Six small CROs are pooling their resources and joining together, looking to capitalize on what they see as a hole in the market for contract research.
With some insight from the Association of Clinical Research Organizations (ACRO) and CROs, such as Icon and Covance, we at FierceCRO set out to identify countries that offer the right mix of features for outsourcing and clinical work. But rather than focus on markets with well-established CRO operations, we looked for promising, upwardly mobile countries.
The years of galling growth in the Indian CRO industry are showing no signs of slowing, and the market will double to reach $1 billion by 2016, Frost & Sullivan says.
Charles River Laboratories is banking on clinical IT to differentiate it from other CROs, increasing its spending on the sector 20% in the second quarter. And the Massachusetts company says the investment has paid off in a growing market share.
While job shedding is bad news for Big Pharma, CROs are reaping the benefits: The organizations are growing in size and expertise by scooping up laid off pharma workers.
A survey of conducted by market research firm Industry Standard Research shows that nearly 90% of surveyed drugmakers would prefer reaching patient recruitment goals at least 10% faster over cutting Phase II or Phase III trial costs 20%.
A report authored by Booz & Co. and Irish CRO Icon looks at how CROs and big pharma companies can improve working relations...