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Recent events at KAI as of :

• July 2010 KAI’s pharmacovigilance department was acknowledged, in the New England Journal of Medicine article entitled Adverse Events Associated with Testosterone Administration, Volume 363:109-122 July 8, 2010, #2, for their review, classification, and coding, using the MedDRA coding dictionary, of adverse events that occurred during a testosterone clinical trial. The Testosterone in Older Men with Mobility Limitations (TOM) trial, sponsored, by the National Institute on Aging, was a placebo-controlled, randomized trial that was designed to determine the effects of testosterone administration on lower extremity strength and physical function in older men with limitations in mobility and low serum levels of total or free testosterone. It was found that in older men with limitations in mobility and a high prevalence of chronic disease, the application of a testosterone gel was associated with an increased risk of cardiovascular adverse events.
  
  
• May 2010 Society of Clinical Trials - KAI staff members gave two presentations and three poster sessions. One presentation, an invited talk, by Scott Brand was on the current trends in electronic data capture for clinical trials. The other talk by Barbara Stern dealt with obtaining insurance for participants in data safety monitoring boards overseeing clinical studies. Of the three poster sessions, the first was in association with the National Institute of Neurological Disease and Stroke (NINDS), and focused on the new neurology common data element web site www.commondataelements.ninds.nih.gov . The poster session reviewed the core and the sets of disease specific common data elements (CDE) that have been and are currently being developed. This CDE web site will provide guidance to researchers in creation of case report forms and what data elements should be collected. The second poster session involved the functionality of the NICHD Pediatric Pharmacology Research Unit (PPRU) clinical trial toolbox. The toolbox is a data collection and management system built upon CDISC SDTM and CDASH standards that enables researchers to accelerate study start up. The third poster session presented by Selma Kunitz and Rene Kozloff reviewed fifteen years of experience carrying out on-site quality assurance process visits and data audits for the NIH. It emphasized what areas site visits focus on and the advantages of carrying out the visits soon after a study is funded.
  
  
• KAI Awarded FDA Contract for The Technical and Clinical Support for the Data Management of Mandatory Adverse Event Reporting for the Peramivir Emergency Use Authorization
  
  The FDA has awarded KAI a contract for the data management of adverse event reports pertaining to Peramivir. On April 26, 2009 the then Acting Secretary of the Department of Health and Human Services determined that a public health emergency exists involving Swine Influenza (now referred to as “2009 H1N1) that affects or has significant potential to affect the public health. On October 23, 2009 the Commissioner of Food and Drugs, issued an Emergency Use Authorization (EUA) for the emergency use of the unapproved drug Peramivir for the treatment of 2009 H1N1 influenza virus in certain adult and pediatric patients.
  
  A crucial part of FDA’s mission is to review pre-market and post-market safety and efficacy assessment of pharmaceutical products. The review of data must occur throughout the life cycle of the product in order to identify adverse events associated with the use of a pharmaceutical product in humans. The peramivir data management program incorporates the receipt, data processing, Medical Dictionary of Regulatory Activities (MedDRA) coding, electronic submission of adverse event reports to FDA’s Adverse Event Reporting System (AERS) using the ICH-E2B standard via the FDA gateway, mandatory follow-up of serious adverse event reports, and analysis of potential safety signals.
  
  
• ANN ARBOR, Michigan - Altarum Institute President and CEO Lincoln Smith announced today that Altarum has purchased Rockville, Maryland-based KAI Research, Inc. (KAI). KAI will become a for-profit, wholly-owned subsidiary and will continue to operate from its current headquarters in Maryland.
  
  "One of Altarum's core research thrusts is health care innovation and innovative care delivery. Purchasing KAI will add a completely new dimension to our effort," said Smith in making the announcement of the acquisition. "KAI's support of clinical research and science-based innovation in health care provides critical new technical capabilities and market presence for Altarum. With the addition of KAI, we have a major opportunity to strengthen clinical research and to enhance the application of research-based knowledge for the most effective and safe health care practice."
  
  KAI was founded in 1986. The company employs approximately 70 employees and generated more than $10 million in revenue in 2008. KAI provides innovative, cost-effective and practical support to the pharmaceutical and biotech industry, academic institutions and the National Institutes of Health (NIH). It currently supports pharmaco-vigilance activities for over 90 marketed drugs and is providing safety surveillance for dozens of ongoing clinical trials. In addition, KAI's clinical research and information technology (IT) capabilities support potential preventive, diagnostic and therapeutic measures in health care practice.
  
  "We are excited about becoming a part of Altarum - it is the logical next step for KAI. There are great synergies between the two organizations that will enable us to make an even greater contribution to improving health care," commented both Selma Kunitz, President of KAI and Rene Kozloff, Executive Vice President of KAI. "By integrating our clinical research expertise with Altarum's research and consulting model, we will be in an even better position to provide our clients with a new range of capabilities." http://www.altarum.org/health-systems-research-news-releases/kai-research-acquisition-012709
  
  
• KAI Research, Inc. (KAI) will present at the 2009 Association of Clinical Research Professionals (ACRP) Global Conference in Denver, CO on April 27, 2009. The poster presentation entitled, "A Clinical Research Toolbox for Investigators," will describe the web-based Toolbox KAI created to support clinical investigators funded by the National Institute on Aging (NIA), NIH. The Toolbox contains templates, sample forms, guidelines, regulations and information materials to assist investigators in the development and conduct of high quality clinical research studies.



• KAI has developed for the National Institute on Aging (NIA) a Clinical Research Study Investigator’s Toolbox. NIA has published the toolbox on their public webpage. The purpose of the NIA Clinical Research Study Investigator’s Toolbox is to provide a Web-based information repository for investigators and staff involved in clinical research. The Toolbox contains templates, sample forms, guidelines, regulations and information materials to assist investigators in the development and conduct of high quality clinical research studies.The NIA Clinical Research Study Investigator’s Toolbox can be found at the following link: http://www.nia.nih.gov/ResearchInformation/CTtoolbox/
  
  
• KAI Research, Inc. is proud to announce their recent participation in the Institute for International Research’s 17th Annual Partnerships with CRO’s held at the Mandalay Bay Resort and Casino in Las Vegas, NV April 14 – 16. During the conference KAI Research emphasized their 22 year history of successfully providing complete CRO services to biopharmaceutical and medical device companies as well as various branches of the US government. They held demonstrations of their internally developed, fully validated, 21CFR Part 11 compliant EDC system, Smart Study©™.
  
  For more information about KAI’s service offerings and Smart Study©™, please contact Marketing, at KAIMarketing@kai-research.com or (301) 770-2730.
  
  
• August 2007 - KAI was 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).