The best Contract Research Organization will have a quality assurance system and expert guidance, have years of experience with clinical trials, and be cost-effective. In addition, they should offer flexible contact options. This is crucial for a successful study.
A quality assurance system for a Contract Research Organization is an essential part of a contract research firm's quality control process. Documents related to quality control include company policies, SOPs (standard operating procedures), and working instructions (SWI).
The quality management plan and company policies, along with other documents, promote reproducibility, transparency, and facilitate communication. SOPs are considered Level 2 documents, and they describe the organization's quality standards and procedures.
The internal process audits are a key element of a quality assurance system. They evaluate how processes are conducted, including drug development, employee training, and compliance with regulatory requirements.
The final deliverable to the client is also reviewed. The QA system also ensures that computer systems are working correctly and meet the intended performance. This includes initial installation and any changes to the systems.
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