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Recent events at KAI
- Meetings and Events
FDA Inspection – February, 2013.
- FDA performed a successful routine inspection of KAI's pharmacovigilance services. This routine postmarketing adverse drug experience (PADE) inspection was generated by CDER’s Division of Compliance Risk Management and Surveillance Office. At the conclusion of the inspection, No FDA 483 was issued. KAI’s pharmacovigilance services also underwent successful FDA inspections in 2005 and 2009.
DIA Pharmacovigilance and Risk Management – Jan 14-16, 2013 Washington D.C.
- KAI is excited, to once again, exhibit at the DIA Pharmacovigilance and Risk Management Strategies conference being held at the Renaissance Washington D.C. Hotel January 14 -16. Stop by our exhibit booth to meet our Pharmacovigilance Director and learn more about KAI’s pharmacovigilance and clinical safety services including adverse event case management, aggregate reporting, literature review, trend analysis, signal detection and risk management services. We welcome the opportunity to discuss how we can assist you in meeting new legislation and regulatory requirements pertaining to pharmacovigilance and clinical safety.
Society of Clinical Data Management Annual Meeting – Sept 22-25th, 2012 Los Angeles, CA.
- Scott Brand will be chairing a session on Risk-based Approach to Monitoring: The Way of the Future, September 24th 10:30 AM
Drug Information Association DIA 48th Annual Meeting – June 24-28th,
Society for Clinical Trials 2012 33rd Annual Meeting – May 20-23, 2012, Miami FL
- Scott Brand will be giving a presentation on Electronic Data Capture (EDC): How Much Quality is Enough, June 26th 3:30 PM
- Susan Li will be giving a poster presentation on Systematic MedDRA Upgrade in Clinical and Post-marketing Safety Databases, June 26th, 11:30 AM
MAGI's Clinical Research Conference - 2012 East – May 20-23, 2012, Washington DC
- Patti Shugarts will be giving a presentation titled, Challenges of Creating and Managing Standards (Common Data Elements) for Use in Clinical Trials.
- Tibor Szentendrei, PhD will be presenting a poster titled, Aging In Numbers – National Health Care Trends And The National Institute On Aging Funded Clinical Trials.
- Selma Kunitz, PhD will be giving a presentation titled, Risk-based Approach to Monitoring: The Way of the Future.
Drug Information Association (DIA) Clinical Data Quality Summit – April 24-25, 2012, Philadelphia PA
Patti Shugarts will be giving a presentation titled, Introduction to Clinical Data Management (session F266 at 3:45 on May 21).
Drug Information Association (DIA) Medical Communications Workshop 2012 – March 5-7, 2012, Orlando FL
- Scott Brand, PhD will be giving a presentation titled, Multiple Levels of Database Quality Auditing.
American Society at the Experimental NeuroTherapeutics Meeting (ASENT) 14th Annual Meeting– February 22-25, 2012, Washington DC
- Miriam Fogelson, MS will be presenting a poster titled, Crisis Management-Involvement of Medical Communications Department.
- Alex Stout and Lisa Hunegs will be presenting a poster titled, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Common Data Element (CDE) Project: Using the NINDS CDEs in Research Projects.
August 2012 - KAI Research was awarded a contract from the National Institute on Aging (NIA) for a Clinical Trials Operations Support Center (CTOS) to help their clinical trial efforts. The CTOS will be providing assistance on all aspects of clinical research, including clinical site safety monitoring, regulatory affairs, data and safety monitoring boards, document processing, data management, statistical support and providing training to investigators. KAI will also update and maintain the Web based NIA Human Intervention Studies Database that tracks all NIA funded human interventional studies and helps NIA staff to manage their scientific portfolio. This five year contract is a continuation of a contract previously held by KAI.
- February 2012, Publication in Clinical Trials National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods, Grinnon ST, et. al.
- September 2011 – KAI working in partnership with FEFA Inc. is designing a web portal for FDA's Center for Drug Evaluation and Research's(CDER), Computational Science Center. This portal will allow real time statistical analysis of data submitted as part of regulatory submissions. Staff from KAI and FEFA will be integrating Oracle databases, SAS programs with expertise in data standards to produce a portal that will increase the efficiency of the FDA's evaluation process.
- July 2011 – The Drug Information Association has released a book entitled
Computerized Systems in Clinical Research, dealing with data quality
and data integrity concepts. Scott Brand of KAI was an invited collaborator
and participated in writing the chapter on clinical system infrastructure and
minimizing associated risks. The book brings together quality assurance and
- June 2011 – KAI staff members will be making two presentations at the annual Society of Clinical Data Management (SCDM) meeting in Baltimore MD, September 11 – 14, 2011. The first presentation is titled, Tools and Techniques for Vendor Management and the second is Re-Focusing the Focus of Data Collection.
- May 2011 - KAI was awarded a contract by the Henry Jackson Foundation to provide data management, site and medical monitoring, safety monitoring and regulatory support to study Standard Wound Care Plus Shock Wave Therapy for Traumatic Wounds of the Extremity. This multi-site randomized clinical trial is designed to evaluate the use of an investigational device, DermaGold, to administer extracorporeal shockwave therapy (ESWT) to individuals with traumatic soft tissue wounds of the extremities.
- May 2011 - Italian pharmaceutical company has chosen KAI to support their pediatric clinical trial. KAI’s role involves project and site management, data management, monitoring, and safety reporting. This study is a multicenter, open label study on infants to determine an investigational drug’s efficacy, safety and pharmacokinetics.
- February 2011 - At the May
2011 Society for Clinical Trials meeting in Vancouver, Canada, KAI staff will be
making a presentation entitled "Challenges of Creating and Managing Standards
(Common Data Elements) for use in Clinical Trials." This presentation
will focus on the processes that were developed and the lessons learned working
on the development of common data elements for NIH agencies. In addition, three
poster presentations will be made by KAI: "Complexities of Conducting Substance
Abuse Trials", "Challenges of Reporting and Coding Adverse
Events in Clinical Trials" and "Making Scheduling More Efficient,
Simple and Reliable: Using KAI's Web-based Shared Calendar Application."
- January 2011 - KAI staff co-authored
an article entitled "Common Data Elements in Epilepsy Research: Development
and Implementation of the NINDS Epilepsy CDE Project." This article
is in press and will appear in the journal Epilepsia in 2011. The work detailed
in this article can be found at the
NINDS Common Data Elements website
- December 2010 - At the 64th
annual meeting of the American Epilepsy Society (AES), KAI staff
members Stacie Grinnon, Lisa Hunegs and Alexandra Stout were contributing authors
on a poster presentation entitled, "National Institute of Neurological Disorders
and Stroke (NINDS), National Institutes of Health (NIH), Common Data Element (CDE)
Project: Applying the General and Disease-Specific CDEs to Clinical Research Projects."
This poster received a Red Ribbon Award for being in the top ten percent in terms
of content quality.
- October 2010 - KAI was recruited
to rapidly deploy a Call Center to process medical information inquiries, adverse
event, and product complaint reports pertaining to a product recall. Within 48 hours
KAI was prepared to accept calls on a 24/7 basis. This required having the reserve
phone capacity to immediately set up 20 stations; customizing our data capture system
that documents the critical information and distributes real time reports to the
client; alerting our human resource department to staff the Call Center under tight
time constraints; and utilizing our experienced on staff trainers who instructed
the Call Center staff on how to respond to a call and elicit the required information.
- September 2010 - KAI Research
was recently named as subcontractor to Emergent BioSystems Inc. (EBSI) to provide
clinical coordination services for a clinical trial of a vaccine to prevent anthrax
poisoning. The contract is funded by the National Institute on Allergies and Infectious
Diseases (NIAID), National Institutes of Health (NIH). As Clinical Coordinating
Center (CCC), KAI identifies, trains, manages and oversees clinical sites that enroll
and manage participants in the study. Specifically, KAI negotiates contracts with
the sites and central laboratories, collects regulatory documents, and assures that
adequate numbers of volunteers are enrolled, and ensures the data collected by the
sites are complete and accurate. KAI will also track information among the sites
central laboratories, Data Management Center, and the sponsor.
- 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
- 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.
- March 2010 - KAI was awarded an FDA contract for data management
of adverse event reports pertaining to Peramivir, which is used to treat life threatening
cases of H1N1 Influenza.
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 was selected by a biotech company specializing in
development of vaccines focused on bioterrorism threats to be a data management
and study operations partner.
- June 2009 - KAI passes an FDA audit with no observations found. This was the second
FDA audit in five years both of which resulting in no findings.
At the Society for Clinical Data Management KAI presented a talk on Data Cleaning-
How to Defend Against Imperfect Data. This talk proposed a three layer approach
to data cleaning including real time edits, complex external edits and training
of clinical staff.
Selma Kunitz, one of the founders at KAI, wrote a chapter with D.J. Richardson on
Data Management and Quality assurance. In Clinical Trials for Neuroscience, 2009.
This chapter provided an in-depth look at producing quality clinical data.
- April 2009 - 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
- April 2009 - 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).