Contract service organizations

Additionally, these diversifications may represent sources of distraction for senior management, which can be exacerbated if the companies are publicly traded. A recent example is the diversification of the contract service organization aaiPharma (Wilmington, NC, U.S.A.) into a specialty pharmaceutical manufacturer. Quintiles (Research Triangle Park, NC, U.S.A.) also diversified aggressively in the 1990s and the acquisition of a patient billing company was problematic. 

Home desalinators are possible only for industrialized countries with a central service organization. They will eventually become available on a rental/service contract basis, as is standard practice for water softeners in many communities. Although rental of water softeners is common in the United States, home membrane-system rental is not estabUshed. 

In 1975, the first commercial entity was formed to provide multicenter, outpatient clinical trial contracting services in the United States. This was the beginning of the modern Contract Research Organization (CRO) industry. It is now composed of thousands of domesfic and infernafional firms involved in medical producf evaluations in humans. The total annual expense globally for clinical trials and related functions necessary for commercial, governmenf, and academic therapeutic product development is estimated at US 50 billion, of which about US 15 billion is outsourced to the contract services market. 

The test facilities in India and China have evolved over the years and conduct a range of nonclinical safety assessment studies for in-house drug development, and also provide service as contract research organizations (CROs) for sponsors not only from India and China but also from overseas pharmaceutical and agrochemical companies. 

Note. As both contract research organizations and laboratory chemical suppliers provide primarily service businesses, their revenues are excluded from the total size of the fine-chemical business, as discussed in Chapter 9. 

External audits of raw material suppliers and contracted services should be handled in much the same way as the internal QAP. Audit protocols should be customized and tailored to the specific organization to be audited. For example, an assessment of a contract laboratory service should be conducted under the auspices of the internal audit team and follow similar procedures in terms of identifying deficiencies, installing corrective and preventative measures, and reports issuing. It is an advantage to employ the same personnel for both the internal and external audits. This approach assures a standardized and uniform audit procedure across the board. 

Dr. Turner is the Chairman of the Department of Clinical Research, Campbell University School of Pharmacy. He is also the President and Director of Scientific Affairs at Turner Medical Communications LLC. His company provides medical writing services to pharmaceutical/biopharmaceutical companies and contract research organizations. The Turner Medical Communications website information is provided at the end of this book s Preface. 

Verifying the identity of cell lines chosen for use should also become a routine task in cell culture laboratories. The number of documented cases of misidentification and cross-contamination of cell lines is growing (Chatterjee 2007). The National Institutes of Health (NIH) issued a notice on November 28, 2007 (NOT-OD-08-017) recognizing the importance of this issue and suggesting that peer reviewers of grant applications and manuscripts submitted for publication should assure that scientists employ available authentication procedures. As the pressure to authenticate cell lines continues, we can expect core facilities and contract research organizations to expand their offerings of such services. 

Contract research organizations can provide services for clinical trials whether they are the simplest phase 1 safety and tolerance studies or complex multicenter phase 3 efficacy and safety studies. Table 3 identifies specific activities that may be considered for outsourcing. These activities are grouped according to four major categories management of the study conduct at clinical sites, data management, data evaluation, and summarization. 

Soltero, R.A. Stagner, W.C. Renley, R.A. Caudill, W.L. The changing role of pharmaceutical development organizations. Contract services 2000 for the pharmaceutical industry. Pharm. Technol. August 2000, 2 (SuppL), 36 2. 

Complexities can also arise when a multinational pharmaceutical company engages the services of another organization, such as a multinational contract research organization (CRO), with potentially different corporate cultures. In each country where the two multinationals collaborate, there is a need to reconcile their corporate cultures, while simultaneously being responsive to local societal and medical cultural considerations. 

Profile Founded in 1970, this contract research organization (CRO) became a wholly owned subsidiary of MDS Health Group Ltd., Canada, in 1995. In mid-1995 Panlabs joined with Tripos in a collaboration to offer pioneering services in drug discovery to pharmaceutical, biotechnology, and chemical research organizations. 

Assessment of contracted-out services, e.g. by storage and distribution agents, contract research organizations (CROs) and quality control laboratories for compliance with GMP, good clinical practices (GCP) and good laboratory practices (GLP), are further elements that may supplement the prequalification process. 

Anything that is not a covered entity e.g., pharmaceutical, biotech, or medical device companies or contract research organizations, typically are not covered entities. It is possible that a large organization may have a health clinic, or an infirmary on site, or there may be doctors there who may provide services, and those services may be billed to an insurer under those circumstances. It is possible that that part of a pharmaceutical or contract research organization is a covered entity. But for the most part, pharmaceutical companies, medical device companies, and contract research organizations are not health care providers, plans, or clearinghouses. 

Identification and synthesis of degradation products and metabolites are some of the other services offered by certain contract research organizations. Both start-up and integrated pharmaceutical companies avail themselves of such services. Some of these companies as well as other fipcos also carry on this work themselves. 

There are private organizations that provide contracted services for planning and management of emergencies. 

Organizations requiring contracted services in locations of their facility where hazardous materials are used or stored must inform those contracted employees of all hazards present. This must be part of the written program. This program should include methods and procedures the employer will use to provide all contractors with MSDSs, information on labeling and other forms of warning, and... 

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