Contract research organization

IF YES. WILL ANY SPON5CH OBLIGATIONS BE TT1ANSFERHED TOTHE CONTRACT RESEARCH ORGANIZATION O 7ES NO... 

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. 

Sample preparation by contract research organization. In Japan, GLP for field residue study work has not yet been established and sample preparation for residue studies by private companies is not authorized. Contract research organizations are limited to prefectural research institutes and MAFF-recognized local research institutes, mainly neutral organizations, such as the Japan Plant Protection Association (JPPA). 

Within any pharmaceutical company or contract research organization, there are groups and individuals outside the statistics department that you work with. Fet s take a look at the functional groups a statistical programmer interacts with most. 

Most contract research organizations and pharmaceutical companies are organized in a matrix management structure. This structure is called a matrix because there are project teams that span various functional departments. It may help to visualize the relationship like this ... 

Sponsor Monitoring. Another important oversight process to ensure quality, compliance, and subject safety, monitors may be employees of the sponsor s medical staff or a contract research organization, or may be independent contractors. In each... 

Contract Research Organizations Role and Function in New Drug Development F. Richard Nichol 407... 

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. 

Major Benefits to Sponsors of Using Contract Research Organizations... 

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]. 

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). 

---