For several NIH Institutes, KAI has developed standard operating procedures (SOPs) for reviewing data integrity and for conducting quality assurance assessments. The assessments examine procedures, protocol adherence, data quality, study medication handling, adverse event reporting, and safety and efficacy conclusions. KAI has also conducted numerous audits for industry sponsored studies.
KAI has developed quality systems for clinical researchers based on their individual compliance needs. KAI conducts assessments of current compliance levels and creates a corrective action plan.
KAI carries out on-site assessment of researchers' regulatory risks to GCP/ICH, HIPAA and Part 11. KAI can then assist with the writing of policies and procedures and the development and delivery of training to ensure effective quality system implementation.
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