KAI's medical affairs department offers a full range of pharmacovigilance and clinical safety services for drug, biologic, and medical device products in a variety of therapeutic areas. Our extensive operational experience allows us to provide an integrated pharmacovigilance and risk management approach enabling companies to monitor their products and identify safety risks proactively.Our services are flexible and scalable to meet clients’ changing needs.
KAI’s core product lifecycle safety services are highlighted below. For a complete list of KAI's services, please refer to our Pharmacovigilance and Clinical Safety Fact Sheet.:
- Adverse event case management
- Electronic submission of ICSRs
- Aggregate reporting
- Literature review
- Signal detection and management
- Risk management
- Medical Monitoring
- MedDRA upgrade, impact analysis and re-coding
- FDA AERS database mining
- Mock FDA audit, process review
- Pharmacovigilance & Clinical Safety training and consultation
KAI's pharmacovigilance and clinical safety projects are supported by ARISg™, a state of the art pharmacovigilance and clinical safety system.
KAI’s pharmacovigilance team underwent FDA inpections in April 2005 and June 2009 to assure compliance with 21CFR 314.80. The outcome of both inspections were positive and no FDA 483 was issued.
Pharmacovigilance and Clinical Safety