Contract research organizations 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. [Pg.603]

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. [Pg.408]

The 3T3 NRU test may easily be performed under GLP conditions in contract research organizations (CROs) and a high-throughput screening (HTS) method was recently reported in the literature. The HTS method produced no false positives, although some false negatives were observed, suggesting that the standard 3T3 NRU test protocol remains necessary for the final selection of nonphototoxic compounds [42]. [Pg.483]

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). [Pg.66]

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. [Pg.16]

Fresh examinations at necropsy have the advantage that the appearance of tissues is not affected by the fixative, but the disadvantage that fewer females can be necropsied on any day. Each laboratory should decide its own working practice, based on the availability and ability of its staff. Testing laboratories, particularly Contract Research Organizations (CRO s) should retain their standard practices and thus maximize their background data. [Pg.64]

Fine-chemical/custom manufacturing (CM) companies account for the largest share of the industry, followed by contract research organizations (CROs) and laboratory chemical suppliers. [Pg.10]

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... [Pg.190]

Lack of adequate trial monitoring by the sponsor or contract research organization (CRO) ... [Pg.20]

Quality assurance (QA) and quality control aspects of trial Contract research organization (CRO) responsibilities Trial design Investigator selection... [Pg.465]

Pharmaceutical and biotechnology companies often use contract research organizations (CROs) to conduct clinical trials for them. These are specialist... [Pg.8]

All studies would be outsourced to contract research organizations (CROs) for study conduct, including any bioanalytical or other assays. [Pg.131]

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