Regulatory requirements clinical research organization

The physician s involvement in clinical research does not end with the completion of the clinical study. Medical reports, clinical study reports, and sections of NDAs must be written. Interactions with regulatory agencies that require the physician s input may occur frequently. Physicians in clinical research may also be called upon to promote new drugs in a scientific environment by organizing symposia and workshops and by reviewing journal advertisements and promotional material for medical validity and accuracy. 

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. 

For many large-scale pharmaceutical development organizations, QA exists throughout the complete life cycle of the drug development process. In the United States, the practice of QA is neither required nor defined by a regulatory standard within each of the drug development activities or stages for clinical research. 

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