Contract service organizations clinical trial 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. 

A multitude of external providers are used to deliver services in clinical trials, for example CROs, site management organizations (SMOs) and academic research organizations (AROs). To ensure that they are capable of providing the services in a reliable manner and to the standards expected in compliance with current regulatory requirements, capability audits are conducted at service providers prior to contracting. 

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. 

Products/technologies This contract research and development group offers GMP production Drug Master Files validation of analytical methods multistep organic synthesis development and consultancy services, such as during clinical trials. 

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