Recent events at KAI

• August 2007 KAI has been selected to be a CDASH (Clinical Data Acquisition Standards Harmonization Initiative) sub stream member assigned to identify commonly collected Lab data elements. CDASH is part of the Clinical Data Interchange Standards Consortium (CDISC).
  
  
• Jan 2007, KAI completed a clinical trial for a major Japanese pharmaceutical company. The project was completed on time and the data was locked one week after the final patient visit. All tables and listings were submitted one week after data lock. The company representative complimented the KAI staff for completing the project on time and for the quality of the work.
  
  
• Jan 2007, KAI will be starting a fifty site clinical trial that will test the bioequivalence of a generic drug. This study will be a nation wide study and will involve all phases of project management and data management
  
  
• April 2006 - Two pharmaceutical companies have contracted with KAI to support their post marketing pharmacovigilance and safety reporting. Additionally, KAI's call center will provide product information to both health care providers and customers for one of the clients.
  
  
• KAI was recently awarded a contract to provide data management, monitoring, analysis and operational support for the clinical studies conducted by the National Center for Complementary and Alternative Medicine (NCCAM). NCCAM, established in 1998, is the Federal government’s lead agency for scientific research on complementary and alternative healing practices. KAI’s efforts will support NCCAM in exploring complementary and alternative healing practices in the context of rigorous science, training complementary and alternative medicine (CAM) researchers, and disseminating study results and information to the public and professionals.
  
  
• KAI is supporting the National Institute of Neurological Disorders and Stroke (NINDS) to set up a Web based data center for clinical institutions participating in the Program of Translational Research in Acute Stroke (SPOTRIAS). The intent of SPOTRIAS is to support a collaboration of clinical researchers from different specialties whose collective efforts will lead to new approaches to early diagnosis and treatment of acute stroke patients.
  
  
• During April 2005 the FDA spent three days auditing KAI’s safety and pharmacovigilance procedures and systems. The audit was successfully concluded and no corrective actions were needed. The FDA auditor stated "I am very impressed with what your group is doing here."
  
  
• KAI has been renewed by NIH to support its associated Pediatric Pharmacological Research Units (PPRU). The mission of PPRU is to foster cooperative research efforts among academia, industry and health professionals.