In we are leading experts in clinical research standard operating procedures and our QA team have extensive clinical research experience and knowledge of the regulations and GCP guidelines. APICES helps our customers to update their quality management system, to prepare or review standard operating procedures and to conduct third party audits.
quality Assurance ensures that clinical trials are performed to meet the requirements of Good Clinical Practice with respect to the ethical and scientific quality standard for the design, conduct, recording and reporting of clinical trials that involve human participants.
APICES quality assurance services include:
Central Laboratory and phase I unit audits which can be part or the selection process or as one of the oversight activities defined in the study.
APICES offers auditing services to sites or to sponsor/CROs as a part of the study oversight to ensure that GCP and applicable regulations are met.
Standard Operating Procedures
APICES support you in the development or improvement of your Quality Management System.
Preparation for regulatory bodies inspections
APICES assists you in the preparation for regulatory bodies inspections and the training and education of study site personnel for the inspection.
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