Merck, which uses both outsourcing and off-shoring to expand its global reach, saw between 25% and 30% savings in its costs after establishing a data management centre in China, Dr. Peter Aurup, vice president of global clinical trial operations at Merck, said at the Outsourcing in Clinical Trials East Coast conference in Philadelphia on Tuesday.
The centre is staffed with about 95% local Chinese employees and about 5% foreign Merck staff that help to train the employees locally. Dr. Aurup said that “the biggest challenge” is a high turnover rate, which has been about 20% in China and 25% in India. Trust is also a big issue, especially in terms of expectations when projects are handed over to local employees, he noted.
Between 2007 and 2008 Merck adopted a hybrid approach to outsourcing and off-shoring, Dr. Aurup said. “We’ve gone from outsourcing about 10% of our clinical trials in 2008 and 2009, to about 50% of trials now,” he said. Trials for Merck’s biosimilar programs, as well as respiratory, diabetes and hypertension drugs in development are almost all being outsourced, he noted.
“Basically we have two ways to execute clinical trials: In-house management of a foreign site and fully outsourced trials through CROs,” he said, noting that the decision to conduct a trial with in-house or outsourced staff is based on whether or not Merck has significant internal expertise in a particular therapeutic area or if there is an opportunity to learn from a partner.
Complex, novel compounds and studies with “soft” PRO (patient-reported outcome) or PRO-like primary endpoints are also most often developed in-house, Dr. Aurup added.
Outsourcing allows Merck “the necessary flexibility” to adapt its pipeline to market conditions in a shorter amount of time, he said.
Eisai’s Experience in India
Eisai, meanwhile, established its global clinical data management centre in India through work with a single CRO there that is managed remotely by Eisai staff in New Jersey, Judy Villafranca, senior director of data operations and data management, said.
The company’s remotely-managed data centre in India, established in 2007, initially sought to reduce the company’s internal costs by 30%. Villafranca did not provide an estimate of how much the centre has saved Eisai but she said the cost savings have been “a tremendous eye-opener.”
The key benefits of the centre include centralized data management, increased productivity, flexibility and innovation, she added.
A centralized standards team in the US also collaborates with the centre in India, which has expanded to include more local contractors for “increased communications,” she said. That team also ensures there are enough resources for oversight, and for process challenges to become quickly brought to their attention.
“We want the India team to feel like they’re a part of the Eisai team,” Villafranca added.