Medical Monitoring Coding MedDRA upgrade, impact analysis and re-coding FDA AERS database mining Mock FDA audit, process review Pharmacovigilance Clinical Safety training...Pharmacovigilance and... Pharmacovigilance and Safety Reporting | KAI Research, Inc. | An Exceptional Contract Research Organization... Safety Medical Communications Data Warehousing Statistical Analysis SAS Programming Quality Assurance Registries NIH Studies (Client use only) Email Access (Internal use only) Privacy...

design, study implementation, safety monitoring, and statistical methodology. Dr. Kunitz serves as Project Director for several NIH contracts. She is a leader in the development... of quality assurance guidelines, data and safety monitoring boards (DSMB), data standards (common data elements) and data warehousing as well as the conduct of clinical trials. Dr...

of disease, clinical- or cost- effectiveness of health care devices, products or processes, safety monitoring, and quality of care. Registries can provide real world evidence on how... menu) anylinkmenu.init("menuanchorclass") HomeContact Us Services Clinical Studies Support Clinical Data Management Pharmacovigilance and Clinical Safety Medical Communications Data... a disease progresses, the safety or effectiveness of a treatment, and how a health care service is provided within or between populations. KAI has experience in large-scale registries...

of this effort and wants to make sure that these studies are in compliance with federal guidelines and regulations regarding human subjects protection and safety monitoring... REMOTE: The Revolution in Clinical Trials In 2011, Pfizer pharmaceuticals launched the Research on Electronic Monitoring of OAB Treatment Experience (REMOTE) study, the first... clinical research network (PACeR Phase I and II, 2011). More.. February 2012 KAI White Paper - Risk Based Monitoring: Maximizing Efficiency While Maintaining Quality Generic Drugs: Why...

Statistical Analysis... HomeContact Us Services Clinical Studies Support Clinical Data Management Pharmacovigilance and Clinical Safety Medical Communications Data Warehousing.... KAI has carried out statistical analysis on data from a variety of EDC and medical monitoring systems. KAI statistical team can be used on a consulting basis to write or review...