CRO即合同研究组织(Contract Research Organization),起源于美国20世纪80

年代初,是指为医药或生物技术企业提供相关技术性和研发性服务的商业企业或科学机

构。近年来,随着中国生物医药行业的快速发展,进一步推进了我国CR0服务产业的形

成和发展,但与此同时,也使CR0服务企业面临着更加严峻的挑战。

CR0服务机构的基本商务模式是研发业务外包,主要是基于药品和生物制品的研发

数目越来越多、研发周期较长、专业分工严格、过程复杂且成本较高、市场竞争激烈的

产业背景而产生的。为了控制研发成本和风险,缩短研发周期,国外大型医药公司通过

整合市场资源,将新药上市前的部分研发工作委托给专业的研发机构进行,CR0服务产

业的发展极大地促进了全球生物医药资源的流动和配置,大大降低了新药的研发成本。

近年来生物医药市场规模正在不断的变化和发展,但CR0企业服务管理体系和发展模式

却变化甚微,大多都面临着服务模式固化的困境。在激烈的国际国内市场竞争的环境下,

如何围绕着市场和客户提供优质的服务,提升企业的核心竞争力,并与客户建立持续稳

定的合作关系,是目前CR0企业领导者和经营者极其关注的问题。

本文结合XYPJ中心CR0服务管理的现状,对企业当前的服务管理模式和服务体系

等方面进行了详细的分析,收集并整理了相关的数据和信息,结合运营管理、项目管理、

人力资源管理等理论知识和学习方法进行研究,找出企业在服务管理工作中存在的问

题,通过提出改善服务管理模式、规范工作制度和流程、加强服务管理团队的建设和建

立有效监督措施等解决方案,以改进企业目前服务管理工作中的不足,达到提高企业竞

争优势的目的。

【关键词】CRO (合同研究组织),服务管理,新药研发

【研究类型】应用研究

Abstract

CRO, means Contract Research Organization, which is commercial

enterprise or scientific organization providing relevant technical and researching

service for medical or biological technology company. It originated from the

United States in the early 1980s, and developed rapidly in recent ten years in our

country, which drives biomedical outsourcing service industry of our country

and also makes the CRO service enterprises facing with severe challenges at the

same time.

The basic business mode of CRO service organization is researching and

developing business outsourcing, which produces mainly based on the following

industry background: the number of pharmaceutical and biological products

researching and developmenting more and more, long development cycle, strict

professional division of labor, the complex process and high cost, intense market

competition. In order to control development costs and risks and shorten the

development cycle, large foreign medicine companies integrate market resources,

entrust part of new drag researching work before appearing on the market. The

development of this kind of industry have greatly promoted the global biological

medicine resources flow and configuration, greatly reduced the cost of new drug

research and development. In recent years, the size of f the industry biomedicine

market is constantly changing and developing, but CRO enterprise service

management system and development mode change little, facing curing problem

of service mode. In the fierce international and domestic competitive

environment, how to provide quality services around the market and customers,

improve enterprise's core competitiveness, and establish steady cooperation