QA for clinical research is an independent department within Altarum’s subsidiary KAI Research Inc. that promotes excellence by ensuring adherence to standard operating procedures (SOP), U.S. Food and Drug Administration (FDA) and International Conference on Harmonisation regulations.
KAI QA specialists have both formal training and years of experience participating in multidisciplinary clinical studies. Our QA expertise encompasses Good Clinical Practices (GCP), training, systems validation, auditing, data security, and Health Insurance Portability and Accountability Act compliance. KAI clients benefit from staff experience in a range of disciplines, including regulatory process, clinical data management, software lifecycle practices, adverse event reporting, and good documentation practices.
The KAI QA Department has successfully led the company through multiple FDA and industry GCP audits. KAI has also supported sponsors and clinical sites during their onsite FDA audits by providing regulatory expertise, documentation, and reports.
For the National Institutes of Health and pharmaceutical clients, KAI provides the following services:
- Train staff and clinical investigators on GCP,
- Perform audits of labs, clinics, and other vendors, and
- Carry out data management and security reviews to verify that FDA 21 CFR 11 and National Institute of Standards and Technologies Federal Information Security Management Act (FISMA) guidelines are followed.
KAI has written SOPs for pharmaceutical and government clients for all areas of the clinical trial life cycle, including:
- Protocol development,
- Clinical trial management,
- Data collection,
- Statistical analysis,
- Document processing, and
- Adverse event reporting.