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【技术产业】制药和生物技术公司选择CRO（合同
CRO在20世纪80年代起源于美国。当时，随着美国FDA对新药研究开发管理法规的不断严谨和完善，使得药品的研究开发过程也变得更为复杂、更为耗时且费用更高。制药企业要在这样一个竞争愈加激烈
的环境中求得生存与发展，就必须尽力缩短新药研发所用的时间，同时又必须控制成本和减少风险。CRO作为制药企业的一种可借用的外部资源，在短时间内可以迅速组织起一个具有高度专业化的和具有丰富临床研究经验的临床研究队伍，并能降低整个制药企业的管理费用。据统计，1995年在美国52％的临床研究项目中有CRO参与承担了不同的工作。1998年，美国投入新药临床研究的费用达187亿美元，而其中35.5亿美元的工作由CRO承担完成，约占费用总额的20％。
根据Intertek的市场研究报告，2000年世界医药行业用于外包服务的费用是300亿美元。制药和生物技术公司的CRO已涉及下列各个阶段：早期药物发现、药理毒性、剂型、配方开发、工艺开发、中间产品和API（有效药品成分）、分析测试、Ⅰ～Ⅲ期临床研究、政策法规咨询、产品物理成型、包装、推广、市场、产品发布和销售支持、药物经济学评价、商业咨询及药效追踪等。
那么，制药和生物技术公司究竟会选择什么样的CRO公司作为他们的合作伙伴呢？
Scientific Expertise, Good Value Most Important When Choosing CRO, Says QPS-Sponsored Study
SAN ANTONIO, Oct. 30 /PRNewswire/ -- The primary factors pharmaceutical
and biotech companies consider when selecting a CRO are the strength of its
scientific expertise and the cost/value ratio associated with the study,
according to a report released today at the annual meeting of the American
Association of Pharmaceutical Scientists.
The study, commissioned by Quest Pharmaceutical Services (QPS) and
conducted by SCORR Marketing with industry experts, indicates that
companies engaged in preclinical development are most interested in a CRO
with demonstrated scientific knowledge and technical skills, as well as one
that offers good value for its expertise and service.
Secondary considerations include the CRO's timeliness in scheduling,
meeting timelines, and executing overall turnaround, as well as its
responsiveness in communicating with scientific personnel, business
development and project managers. CRO decision-makers clearly articulated
the importance of service quality, priority setting and the ability for
rapid, effective problem-solving in service provider selection. Other
important CRO attributes include resources to handle the job, location of
laboratories, quality of reports, flexibility as study progresses (and
potentially changes), and history of prior relationship.
"It's crucial to QPS that we have a clear picture of what is important
to our current and future clients, which is why we undertook this study,"
says Ben Chien, Ph.D., President and CEO of QPS, which has headquarters in
Delaware and laboratories elsewhere in the United States and Taiwan. "And
knowing our clients' perceptions, preferences, and habits
enhances our ability to meet their evolving needs and to earn us
consideration when they are making their outsourcing decisions."
Members of the SCORR team have conducted numerous assessments of and
for pharmaceutical and biotech companies over the last 15 years. The QPS
report released today was based on in-depth interviews with a random
sampling of U.S. industry experts.
"When all things are equal, price becomes the weighing mechanism for
many buying decisions," notes Cinda Orr, President of SCORR.
"Differentiation is best achieved by meeting the real challenge in the CRO
industry: developing flexible, knowledgeable science delivered with
impeccable service and responsive communication."
Founded in 1995, QPS has DMPK facilities in Newark, DE, and in Taipei,
Taiwan, and partners worldwide with drug researchers to provide services in
various bioanalytical and ADME areas. 相关阅读：
1.临床试验外包成大势所趋，亚洲地区融入全球产业链
http://www.istis.sh.cn/list/list.asp?id=809
2.世界医药外包的发展趋势及中国面临的机遇和挑战
http://dcscyxs.mofcom.gov.cn/questionnaire/_news/html/2006/1/6/1136529044125.html
3临床试验，下一个国际化交集
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作者:admin@医学,生命科学 2010-11-17 17:11
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