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Areas of excellence include clinical studies support, clinical data management, pharmacovigilance and safety reporting, medical communication, data warehousing, statistical analysis, and quality assurance.
CLINICAL STUDIES SUPPORT
- Protocol development through regulatory submission
- Electronic CRF (eCRF) clinical data capture and data management
- Study assistance services
- Clinical monitoring
- IVRS - Randomization and Patient Diary
- Clinical study report preparation
KAI offers a range of clinical study assistance from protocol development through successful regulatory approval. KAI staff members write protocols, create CRFs, perform data management; train and initiate sites; manage study operations; monitor sites and prepare safety and efficacy analyses, study reports, and FDA submissions. KAI interacts with sponsors, investigators, and clinical site staff to ensure exemplary studies and products.
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