Local CROs key to avoiding BRIC wall, says report
Shaylyn Pike, senior clinical development analyst for Cutting Edge Information, told Outsourcing-Pharma that pharmaceutical sponsors no longer think it only sufficient that CROs carry out high quality work, have good clinical practice (GCP) experience and regulatory knowledge.
Instead Pike believes they are favouring CROs with local expertise, reasoning that such insight makes delays are less likely and provides an increased chance of research success.
“[Local CROs] offer intimate knowledge of their country and region, providing benefits in regulatory filings, contracting with sites, finding investigators and patients, and managing the overall trial,” said Pike.
Pike said that while many multinational CROs are slowly realising they lack local expertise in ‘pharmerging’ markets, “in many cases, it is not cost or time effective to establish this level of knowledge in-house; especially when looking beyond the BRIC countries.”
This trend is likely to continue, according to Pike, who suggested: “It is unlikely sponsors will turn back to multinational CROs without a contractual understanding that the CRO will be cooperating with local experts on ground at the trial site.”
The scores of CROs offering services in BRIC markets are allowing drugmakers to become increasingly ‘pickier’ said Pike, who believes both local and multinational CROs must find new ways of demonstrating their capabilities to ever more “savvy” sponsors.
Differentiating the ‘big four’
Moreover, a major mistake made by CROs with an eye to establishing themselves in a BRIC region is thinking of these countries as a single entity, said Pike. The big four – Brazil, Russia, India and China – all possess unique cultures, demographics, histories and regulatory systems.
“Companies from the US and Western Europe often believe that the differences among these countries are irrelevant,” she claimed. “Even worse, many do not consider the cultures and regulations of BRIC to matter in clinical development.”
Pike explained that factors such as cultural differences, previous colonisation in India, economic competition in China and lost global stature resulting from past wars in Russia, have all contributed to BRIC citizens' distrust of multinational companies.
Although lower costs and higher patient populations mean global contract research services firms will always maintain a presence in emerging regions, Pike believes the most promising companies are small, country-specific CROs.
“Multinational CROs and pharmaceutical companies can be considered outsiders in the region,” she said, asserting that this is why many “large CEOs have partnered with local companies.”
