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QUALITY ASSURANCE
At INTRIALS problems must be predicted, not detected. Thus, we audit the trials in the first stages of clinical research development. This helps to identify potential problems and implement corrective measures very early in your study, to prevent interruptions and the costs associated with not anticipated problems.
Our Quality Assurance team possesses the required expertise and is frequently exposed to QA and ICH guidelines training, so that you receive complete and customized services to ensure data accuracy and Clinical Research Excellence.
INTRIALS Quality Assurance services encompass:
• Internal System of Quality Assurance;
• Contract audits;
• SOPs preparation and revision.
Internal Quality Assurance Processes
INTRIALS Internal Quality Assurance Processes are designed to assess every detail of the procedures, and play a significant role to improve efficiency of all staff involved in the trials.
We conduct a comprehensive evaluation about the adhesion and compliance to:
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SOPs, Good Clinical Practices, Regulatory requirements, Study Protocol, Clients' instructions, Contractual obligations. |
Contract Audits
Contracted Audits are crucial for the success of any development process, helping to identify questions and inconsistent points to be surpassed - a key-attitude to reach a superior pattern of quality. INTRIALS provides the following audits:
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Protocol and Informed Consent (in conformity with GCP and SOPs), Regulatory Documents, Documentation of the Master File, Investigation Centers. |
Preparation and Revision of SOPs
INTRIALS develops and revises SOPs for sponsors and research centers. SOPs revision must be done at every change in procedures, in order to ensure that the procedures reflect exactly the current practice.
Contact us to access a presentation about the region and to learn more about how INTRIALS can assist you conduct studies in Latin America. |
