Contract Research Organizations clinical CROs

Until recently, pure paper-based data collection systems have predominated in clinical trials. However, they are still being used by many contract research organizations (CROs) either because of financial constraints that prevent them from investing in newer technology or because they deal with small clinical trials that do not justify that investment. Other CROs consider the paper-based data collection method to be the safest and most reliable approach to data collection. 

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. 

A dimension of the increasing disintegration of pharmaceutical R D is the growing use of contract research organizations (CROs) to conduct clinical trials of new drugs. By 1999, 23% of trials were outsourced to CROs (Azoulay 2004, pp. 1593,1600). In general, the more data-intensive projects are outsourced, while knowledge-intensive projects are more frequently undertaken within pharmaceutical companies (p. 1592). 

Outsourcing strategies offer a highly flexible and adaptable strategy for clinical development support. This approach to drug development generally involves the use of contract research organizations (CROs) and contract analytical laboratories, which perform a variety of specialized clinical development-based functions. This practice has... 

Pharmaceutical and biotechnology companies often use contract research organizations (CROs) to conduct clinical trials for them. These are specialist... 

The cost of a clinical trial arises from both internal and external costs. Internal costs are those incurred within the sponsor s organization (personnel, office supplies, etc.) external costs are those incurred on such items as investigators, laboratories, travel and so on. Quantification of the internal costs, especially those associated with personnel, has proved a persistent challenge, as discussed below. The costs of a typical contract research organization (CRO) may be viewed as shifting costs from internal to external. 

Outsourcing Clinical Drug Development Activities to Contract Research Organizations (CROs) Critical Success Factors... 

Fig. 2 This figure represents the career options for individuals interested in the clinical pharmaceutical sciences. Abbreviations PhaRMA, Pharmaceutical Research Manufacturers CROs, Contract Research Organizations SMOs, Site Management Organizations NIH, National Institutes of Health CDC, Center for Disease Control and Prevention HCFA, Health Care Financing Administration FDA, Food and Drug Administration EPA, Environmental Protection Agency CDER, Center for Drug Evaluation Research CBER, Center for Biological Evaluation Research.

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. 

Contract research organizations (CROs) should be inspected as part of the assessment process to verify that raw data correspond to submitted data, and to assess compliance with standards during the conduct of clinical and bioequivalence studies. Monitoring and requalification should ensure that the principles of good clinical practices (GCP) (20), good practices for quality control laboratories (10) and GLP (19) are adhered to. 

Note the acronym CRO is used throughout this document to refer not only to a contract research organization (CRO), but also to any organization involved in the conduct or analysis of in vivo bioequivalence studies. As defined in the International Conference on Harmonisation (ICH) Tripartite Harmonised Guidelines, Guidelines for Good Clinical Practice (5), a CRO is a person or an organization (commercial, academic or other) contracted by the sponsor to perform one or more of a sponsor s trial-related duties and functions. 

The process of data summarization, encompassing both medical interpretation and scientific writing, can be one of the more challenging aspects of a clinical program. The greater the level of sponsor involvement in these activities, the more internal ownership is reinforced and the sponsor is better able to defend the data. This is not to say that CROs cannot play an important role in these steps. Contract research organizations that have medically trained personnel with expertise in particular therapeutic areas can be an excellent resource for small companies that may have no internal medical staff. 

CRO Contract research organization CTC Clinical trials certificate CTM Clinical trials material CV Coefficient of variation CVS Cardiovascular system... 

To ensure that the standards for clinical research are established before studies begin and to check on compliance with those standards, many fundamental systems and processes must be defined by pharmaceutical companies and contract research organizations (CROs). These are outlined in Table 8.1. 

FDA can audit the records of the study sponsor, as well as contract research organizations (CROs), to review standard operating procedures and all of the documents related to a particular clinical study, including electronic databases. Since 1981, nearly 200 such inspections have occurred. Departures from regulations requiring voluntary corrective... 

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