choosing such supermarket offerings is that the quality and value for money is not always equally high across all areas. The discerning buyer is better served by selecting different companies with expertise particular to the service sought.
为适应复杂性，某几个大的CRO公司正在增加提供服务的范围，然而顾客的风险是在品质价格上并不是同等的高，有识别能力的顾客通过专业技能选择不同的公司可以得到最好的服务。
Selecting, planning and budgeting for the use of a CRO are critical to project success. CRO use continues to increase in the U.S. and Europe and yet sponsors continue to encounter difficulties in these areas. Typical problems include:
挑选，计划和预算CRO的使用是项目成功的关键。在美国和欧洲CRO的使用不断增加，而主办者也继续面临困难在这个领域。主要问题有：
? Insufficient knowledge of specialist providers of the service required 服务必备的专家提供者的知识缺乏
? Finding the time and resources for evaluating and selecting a high-quality, experienced CRO ? Unrealistic bid expectations
? Poor bid specification leading to poor CRO performance ? Difficulty comparing competing bids
? An inability to specify add-on work at rates and terms comparable to the initial contract. 寻找时间和资源评估和选择一个高质量的有经验的CRO 不切实际的报价期望
低廉的价格导致低廉的结果 难以比较竞争价格
详细说明而外的工作比例和时间与最初的合同相比。
Sources of Information on CROs
A number of companies work at the interface between provider and client. These intermediaries provide a range of services, from information databases to consultancy, and in some cases even run studies themselves, acting as a sort of meta-CRO.
大量公司在供应者和顾主之间工作，这些中介提供广泛地服务，从情报数据库到顾问，有时他们甚至亲自投入到研究中，扮演CRO中的一种角色。
Each company offers more extensive information on CROs than pharma or biopharma companies tend to have in house, which allows savings on time and contract costs by facilitating charge
comparison and negotiation of better unit rates over initial competitive bids. Better information permits better CRO selections, thereby reducing the risk of selecting poorly qualified CROs. Mistakes in selection can be very costly both in terms of increased project costs and poor performance, particularly where there may become a need for additional studies to make up for poorly conducted contracts. 这样的公司在房间里就可以提供比生物和制药公司更多的关于CRO的信息，他们通过在最初的竞争价格上得到通过商谈得到统一的比例，可以降低合同成本，节约时间。更多的信息允许更好的CRO的选择，因此降低了选择质量低下的CRO的风险。错误的选择也会导致增加成本和低效的运作。尤其是在那些需要做额外的研究成为一个恶劣的人工合同。
DataEdge (www.dataedge.com) has collaborated with 30 pharmaceutical companies to define benchmarks and divide unit costs into 20 common budget categories, ranging from pre-trial regulatory filing to manuscript preparation. They prepared a unified process for CRO selection, which the
company claims makes the preparation and evaluation of requirements for proposals a much faster job. The CRO responds to a proposal involving detailed tasks described in familiar terminology. This all-inclusive proposal reduces initial and add-on costs by eliminating double-charges.
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Preferred-provider rates can be readily compared to industry rates found in the database. DataEdge?s database lists CROs in terms of project experience and includes details on financial qualifications. The benchmark capability allows for better comparisons between preferred provider rates against preferred provider rates paid by other companies, and comparisons with other means of carrying out the work, such as using internal resources.
DateEdge (www.dataedge.com)已经合作过30家制药公司，定义基准，划分单位成本为20个分类。从试验前整理到资料准备，他们准备了统一的标准操作供CRO挑选，这样公司可以进行更快的准备和评价。CRO要对建议作出反应包括用专业术语对任务详细描述，这样包括所有的建议通过排除双倍费用来减少最初和额外的成本最初和最终的
首选的提供者比例能够与在数据库中的工业比例做比较。DataEdge的数据库列出了CRO的项目经验的条款包括财务条件。基准的能力允许在首选的提供者比例和首选提供者的价格基准做比较，并与其他进行的工作做比较例如用内部资源。
Arachnova (www.arachnova.com) is a relatively new company on the scene, offering services in project leadership and outsourced project management, and providing a database (the Technology Web) with more than 1,000 companies specifically in the CRO industry. Limited searching of the database is freely available via the BioPortfolio web portal at www.bioportfolio.com, but a CD-ROM version is available at a commercial rate. A full-scale online version of the database is expected to be available with multiple search capabilities in October 2001.
Arachnova (www.arachnova.com)是个新公司提供项目领导和外包项目管理服务，提供在CRO工业中的1000多家专业公司数据库，有限的数据库搜索可以免费通过BioPortfolio网页获得 （www.bioportfolio.com），但CD-ROM格式的文本只能通过商业途径够买。
The consultancy services include instigation and implementation of early-stage development projects for a range of companies, particularly for small biotechnology sector companies needful of flexible management skills. Such companies use outsourced relationships extensively for their development programs, and often need professional development help to complement their discovery focus and take their projects forward to a point from which they can be outlicensed. In addition to consultancy on project leadership and management, Arachnova works in other areas, including the preparation of expert reports, the completion of due diligence projects and acting as expert witnesses.
咨询服务包括早期开发项目的促进和执行，为一系列公司特别是小生物技术公司需要灵活管理技术，这些公司广泛地运用外包，完成专门的证明。
A rather different model is employed by Inceutica (www.inceutica.com), founded in October 1999 to deliver web-enabled solutions for pharmaceutical/biotech R&D. Inceutica?s technology platform aims to connect pharma and biopharma companies to service providers with the particular therapeutic expertise sought, regardless of geographical or organizational boundaries. The client company will post the request for proposal (RFP) form on the website, making it available for review by service vendors, allowing them to submit and revise project bids, monitor project status and conduct ongoing dialogue directly with the client company, who then reviews all bids and selects the vendor that best fits their needs. Inceutica has no direct involvement in the two parties? communications.
Technomark (www.technomark.com) has provided a register of CROs since its conception in 1988. Initially focussed on toxicology and clinical outsourcing, an addendum has recently been published which identifies contract pharmaceutical manufacturers and chemical synthesis companies. The information provided by the Technomark registers has also recently been enhanced by an on-line version of the database. As well as basic contact information, there are details on the finances and the number of staff in the CRO. This information is not provided for all CROs, and is particularly lacking
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from the small, often private entities, which make up the bulk (in number) of the service providers. While it is often said that it is the small private provider that is more financially exposed, the recent failure of Oread exemplifies the wide range of this business risk. (It is interesting to compare the failed strategy of Oread which was to become a fully fledged multi-disciplinary development service provider with that of Albany Molecular Research, which, while expanding its offerings, has nevertheless remained focussed on chemical service provision.)
A smaller version of the Technomark database is provided by InPharm (www. inpharm.com) in the FlexiPages part of the website. The information, which is given more in a directory format than a database, provides contact details for a wide range of agencies and suppliers serving the
pharmaceutical and healthcare industries. The information is accessible for free on the web, and can be searched by keyword or browsed by category. There is little information on many of the featured companies, but some have a profile with more information. Although the total number of companies is around 1,000, few are specifically in the contract pharmaceutical R&D field. From a business
perspective, this data is funded by organizations paying for a profile to be included on the website. This has the advantage of being free to the user, but the disadvantages of being partial in scope and biased towards those that do pay for a profile.
The Middle Tier 中间排列
The merger trends of a few years ago in pharmaceutical outsourcing posited a future with ever fewer, ever larger providers. While there was still room for niche CROs, the trend was to provide a wide range of pharmaceutical development services in one organization. The real business challenge from this reorganization was to use this very large development resource to optimize the drug development process for the benefit of the pharmaceutical industry. As in any industry sector, integrating the activities of a large CRO organization, particularly one that has recently merged, is a substantial internal challenge.
近几年制药企业外包的合并越来越明显，当然也有小型CRO的生存空间趋于在一个组织中提供更广泛地服务，联合成更大的公司有利于接受挑战。
This trend has now been countered by the emergence of a new tier of company between the sponsor and the CRO, and has parallels in the outsourced management of clinical trials through site
management organizations (SMOs). SMOs provide CROs with physicians and coordinators to enable clinical research coordination and monitoring of Phase II, III, and IV clinical trials. The SMO often has a number of therapeutic specialties and access to a large and diverse patient population for inclusion in the proposed research. In addition, SMOs usually employ full-time certified clinical research personnel for trial documentation and case report form completion. SMOs are judged by their ability to enroll patients in studies and start and complete a clinical drug trial in a timely manner. In essence, therefore, SMOs aim to streamline the functions of CROs and operate between the CRO and the investigator. 这样的趋势不能被一些新公司的出现来计算。通过现场管理组织（SMO）临床实验外包管理有了新的轨道。SMO为CRO提供医师能够进临床试验协调的人和II, III和 IV期试验的检查。SMO通常有许多治疗领域的特长，可以迅速大量的召集到病人为试验、而且，SMO通常雇用全职的通过审核具有临床研究专员来完成试验文件和病例报告表。SMO通过登录病人的能力来判断好坏，，并及时开始和结束临床药物试验。SMO的本质作用是提高CRO的效率。并在CRO和调查人之间工作。
Unless and until the cost-savings and efficiencies promised by the recent round of CRO mergers can be realized, there is room for such intermediaries, which can operate in a highly flexible sense to add value to the outsourcing process in pharmaceutical R&D.
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除非和直到CRO的合并可以节约成本提高效率才能实现。目前中介组织仍有发展的空间，可以更加灵活的运作在R&D中提高外包的作用。
The CRO business is highly competitive and in this respect it is similar to the product-based industry it serves. However, there is a major difference in the way the two industries compete for business. The pharmaceutical industry can hope to very clearly differentiate its products based on hard data obtained from efficacy safety and pharmacoeconomic studies. Even in today?s new healthcare environment the market place is less price sensitive when clear clinical evidence for product advantage can be shown. This is in marked contrast to the CRO industry, which has an ever-shrinking number of large well-founded mature customers and a significant number of young small and venture capital hungry customers. Differentiating and selling technical services to senior R&D management is very different from marketing products to doctors and healthcare providers. Claims that studies can be completed faster, error free and reported to agreed timelines are simply not credible to customers: all CROs make these claims. CRO企业竞争激烈，在这方面与产品服务行业类似。但仍有重要的一点不同制药工业可以明显地区分，它的产品建立在从安全性和药物经济学研究中获得的大量数据。即使今天在健康领域市场中价格灵敏度很小，是得到临床验证的原因，这于CRO形成显著对比，他有数量不断缩小的大的良好的成熟的客户群和一只数量很大的年轻的小的风险资金缺乏的客户群。区分和出售技术服务给高级的R&D管理明显不同于销售产品给医生和卫生保健机构。要求试验完成迅速，无错，被报到及时并使客户相信，所有的CRO制定要求。
The real added value that an individual company might bring in its service offerings needs to be more carefully considered. Given that the facilities, GLP status and technical competence and the like are mostly undifferentiated for the successful CRO, the simple answer has to be knowledge and
experience, that is, the technical and scientific complexity of the pharmaceutical development process. CROs that can capture this knowledge by employing professionally experienced leaders who can then cultivate the scientific culture of pharmaceutical development into their organization will be the winners of the fight to capture increased market share in a generally mature or shrinking market. Such people-based elements last only as long as these individuals are employed by the organization. Know-ing the good and bad elements comes from experience of working relationships; expertise in one area does not imply talent in all areas. In some cases, specific technologies might add a further element of uniqueness, for example inhalation technology, continuous infusion technology, telemetry and transgenics.
私人公司能从它的服务中带来真正额外的价值，应该被关注，它的管理灵活性和GLP是施舍情况、技术竞争力与成功的CRO并无不同。很简单的答案，是具备了知识和技术，也就是说，在药品研发过程中的技术和科学的复杂性。CRO通过雇佣在行业内有经验的带头人来获得知识，他们可以培养科学的药学研发的文化进入组织里，而成为竞争的赢家，在普遍成熟和萎缩的市场里获得不断增长的份额。这样的以人力资本为基础的策略竟会持续直到只要这样的员工不断被雇佣到企业里，工作中获得的经验使我们知道原理的好坏，在一个领域内的专业知识并不意味着所有的领域都可以有才华。有时候专业技术可以带来深入的原理，例如
There is increasing recognition that specialist companies can add value to the outsourcing process and many now see the role of an intermediary organization as beneficial to serving the research-based pharmaceutical sector. Indeed we should not be surprised. The word ?entrepreneur? literally means ?to take between?: in all industries, as they mature and become more integrated, companies often become more specialist in their offerings and opportunities can open up for new commercial intermediaries. A useful comparator here is the computer manufacture industry, which is highly fragmented and based
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on outsourced networks. A final validation of this tenet comes from the large CROs themselves, which, in order to offer the one-stop shop from which they can benefit substantially as a provider, often resort themselves to sub-contracting. It will be interesting to see how this trend develops in the next few years, in an age when the business of pharmaceutical development is still growing, becoming ever more international in scope, more competitive and more complex.
越来越多的人意识到专业化公司可以为外包带来价值，同时人们把中间公司的角色看作服务于以研究为基础的制药部门。事实上我们不应该感到惊讶，“企业家”一词已意味着“to take between”，在所有的工业产业中，当他们变得成熟完整，公司经常会变得更加专业与他们的服务，机会也为更多的商业中介打开。在这里列举一个很有效的比较，电脑制造业被分成无数个部分，依赖于外部资源的网络。这种原则的最终确立来自于大型CRO，他们通过提供阶段性的服务，获得稳定的充足的收入，而凭借于缩小。，将很有意思看到这种变化趋势。
Outsourcing is no doubt a trend that will increase and, in order to improve its efficiency, the ways in which it is managed are likely to see dramatic change.
外包毫无疑问是一种趋势，为提高效率，管理将会发生戏剧性的改变。
How will the emergence of specialist intermediary organization affect the process? 专业型中间公司的出现将如何影响进程？ By David Cavalla MA PHD Arachnova
摘自 www.contractpharm.com/Oct011.htm
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