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Pharma and Biotech Firms Are Rethinking Their Approach to Outsourcing
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"The global economic downturn and operating pressures to launch new products faster and more efficiently have increased the need to leverage the benefits of outsourcing," said Tufts CSDD Senior Research Fellow Ken Getz. "But sponsors are rethinking how to best integrate CRO partners, given their unique corporate cultures, development and operating philosophies, and legacy processes and systems. That's why integrated partnerships are being supported through hybrid outsourcing relationship models."
According to Tufts CSDD research, annual growth in drug sponsor spending for contract clinical services over the last decade has outpaced annual increases in global spending on new drug development, 13.4% vs. 9.1%.
Reliance on CROs, however, has been rewarded, Getz said, citing research he has conducted which shows that greater use of CROs has been associated with faster development at comparable quality to projects with little to no CRO use.
The executives, who met as part of the Tufts CSDD Executive Forum Roundtable, agreed that good governance -- critical to the success of alliances and partnerships -- is supported by:
• Sharing definitions of the relationship, goals, and processes, to assure a standard and consistent approach to oversight.
• Instituting an audit plan that lets sponsors adopt a "trust but verify" approach to CROs, enabling sponsors to evaluate CRO methods and systems without co-monitoring trials.
• Keeping the joint executive committee focused on learning how problems get solved, not how to solve them.
According to Tufts CSDD research, annual growth in drug sponsor spending for contract clinical services over the last decade has outpaced annual increases in global spending on new drug development, 13.4% vs. 9.1%.
Reliance on CROs, however, has been rewarded, Getz said, citing research he has conducted which shows that greater use of CROs has been associated with faster development at comparable quality to projects with little to no CRO use.
The executives, who met as part of the Tufts CSDD Executive Forum Roundtable, agreed that good governance -- critical to the success of alliances and partnerships -- is supported by:
• Sharing definitions of the relationship, goals, and processes, to assure a standard and consistent approach to oversight.
• Instituting an audit plan that lets sponsors adopt a "trust but verify" approach to CROs, enabling sponsors to evaluate CRO methods and systems without co-monitoring trials.
• Keeping the joint executive committee focused on learning how problems get solved, not how to solve them.
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