New Trends in Outsourcing and Offshoring
It's more than 20 years since outsourcing was used in the pharma industry, but the phenomenon remains as popular as ever. Sponsors continue to invest heavily in product development, but they are spending less and less on internal support staff. India is proving an increasingly attractive location for clinical research organizers.
It's more than 20 years since outsourcing was used in the pharma industry, but the phenomenon remains as popular as ever. Sponsors continue to invest heavily in product development, but they are spending less and less on internal support staff. India is proving an increasingly attractive location for clinical research organizers.
Industry's growing adoption of electronic data capture (EDC) may well accelerate India's rapid emergence as a country in which to base multinational clinical trials, according to Dr. Nermeen Varawalla, vice president of international business development at PRA International.
India is an excellent place to introduce EDC because most investigators are receptive to new technology, they have a fast Internet connection, and they have not had any bad initial experiences of EDC, she explained. Thus, India can help to provide the all-important metrics that are vital to confirm the cost-effectiveness of EDC, and it may also have a role to play in software development and manual data entry.
"Sponsors value the operational flexibility offered in India," noted Varawalla. "Investigator fees and treatment costs are approximately 30% less than those in the U.S. Domestic travel may be cheaper due to the urban concentration of sites and lower fares and tariffs, and the support services (printing, translation, couriers, data management) have improved."
Earlier this year, FDA carried out a successful audit of three sites in Southern India. Furthermore, the regulatory process is now more streamlined, and approval for study conduct can take as little as 10 to 12 weeks. The Indian Council of Medical Research is developing training and accreditation for ethics committees. Finally, the ethnicity of trial subjects tends to be a less common problem compared with other parts of Asia because most Indians can be regarded as Caucasians, she said.
Varawalla admits that basing trials in India can be a risky business, however. A thorough knowledge of local regulatory processes and operations, as well as deep relationships with local physicians and medical centers, are essential for success, she said.
During the same plenary session, Ken Getz, chairman of CISCRP, noted that the global partnership management focus is still primarily on achieving cost savings and streamlining the contracting process. Sponsors are changing to better manage the increasingly diverse contract provider market, and capacity-driven outsourcing remains the primary strategy, he said.
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