Updated on 18 September 2013
The US Regulator, FDA has also made things a little easy for the CRO and pharma industries. In a new set of guidelines, FDA has mandated that clinical trial sponsor companies need not do costly, on-site inspection of trial sites except at high risk locations. Because FDA has concluded that centralized inspection systems are better at detecting anomalies in the trial data rather than physical inspection of sites. This measure should reduce the costs of clinical trials as well speed up the timelines.
Overall, the future looks bright for CROs in Asia in spite of much-publicized regulatory delays and corruptions scandals involving some of the world's biggest pharma companies.
5th Annual BioSpectrum-CMR Survey of the Contract and Clinical Research Organizations 2013
This report, by BioSpectrum Asia in association with CyberMedia Research (CMR), a market intelligence, market research and strategic lifesciences, and innovation advisory firm from Asia Pacific, is based on a primary survey conducted by CMR across the Asia Pacific region. Senior clinical research organization executives from India, China, Malaysia, Singapore, South Korea and Australia participated in the research.
The survey included a mix of quantitative and qualitative research, administered through email, and direct telephonic interviews with senior executives and experts in the Asia Pacific region. In addition, extensive desk research was conducted to complement the survey findings. Individual company data is not made public in this annual report, in keeping with confidentially expected by the participating companies. Aggregate findings are published.