TAKE’s Chief On ‘New Normal’ For CRO Audits, Outcome-Based Pricing
TAKE Solutions’ managing director outlines in an interview with Scrip a range of issues shaping the clinical research segment, including the "humongous" number of audits firms face against the backdrop of compliance woes in the sector, the “reach-out” from Chinese firms amid evolving regulations and a potential shift to outcome-based pricing in the CRO space.
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More Indian companies are headed to China, with Cipla the latest to seal a joint venture there, though the firm has previous links with the country. Respiratory products will lead Cipla’s line-up in China, a market seen as a crucial cog in the firm’s future road map.
India’s new clinical trial regulations could revive sponsor interest in the country, but some norms around local Phase III trial waivers appear open to interpretation and could potentially weigh down momentum.
Cipla’s generic of Merck & Co’s Proventil makes significant inroads in the US, with the Indian company confident that it has both a strong cost position and large capacity to take on competition. Pricing in the segment currently remains ‘respectable.’