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EduNeering and NIH Partner to Deliver Global, Computer-based Training Program to Assure Proficiency in Good Clinical Practices (GCP)

November 1, 2006 - Princeton, New Jersey - EduNeering, a leading provider of knowledge management solutions to improve regulatory compliance and business value, will be providing technology-based learning services to implement a global Good Clinical Practices (GCP) program for the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). EduNeering will work with NIAID in collaboration with SAIC-Frederick, Inc., under its prime contract with the National Cancer Institute, to implement this global GCP program.

"NIH is one of the world's leading medical research centers, and the focus of medical research in the United States," said Dr. Donald A. Deieso, President and CEO of EduNeering. "It is a privilege for EduNeering to contribute to the skill sets of NIH researchers so as to enable them in developing new knowledge that will lead to improved public health for millions around the world."

EduNeering's solution will form the foundation of a comprehensive knowledge initiative. The solution will deliver, assess and document knowledge on the methods used in the conduct of clinical research via computer-based courses and standard operating procedures on topics such as informed consent, research ethics, drug safety, and adverse event reporting. Training in Good Clinical Practices is required of any recipient of a NIAID research grant, their study staff, and key NIAID personnel.

EduNeering's solution, called ComplianceWire^®, enables the timely distribution, confirmation of receipt, and documented proficiency through objective testing of critical information. The system is 21 CFR Part 11 validated and creates an audit-ready trail that meets all documentation requirements in accordance with the U.S. Food and Drug Administration (FDA) regulations.

EduNeering's solution is used by pharmaceutical, biologic and medical device companies around the world to implement knowledge and compliance management programs for both internal staff and external investigators, Contract Research Organizations (CROs), Institutional Review Boards (IRBs), and clinical study subjects.

Denise Queffelec, Senior Vice President of EduNeering's Clinical Practice, says "NIAID is a lead organization in the global battle against infectious, immunologic and allergic diseases such as HIV/AIDS and avian flu, and it also has a history of research into a host of deadly diseases, from malaria to tuberculosis. We look forward to playing an important role in NIAID's critical research mission."

In 1999, EduNeering was chosen by the FDA as its only learning technology partner under a unique Cooperative Research and Development Agreement. The agreement and partnership between EduNeering and FDA was recently expanded and renewed through 2011. Under the agreement, EduNeering designed and implemented the training program for FDA's Office of Regulatory Affairs. The virtual training program, entitled "ORA U," is used by FDA to train more than 30,000 inspectors and investigators around the country.

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EduNeering (www.eduneering.com), a Deloitte Technology Fast 500 Company, develops technology-enabled knowledge solutions for improving business performance and assuring regulatory compliance. For more than 25 years, the company has served corporate and government clients in the life sciences, healthcare, energy and industrial sectors using proprietary platforms that integrate business, learning and technology. Headquartered in Princeton, NJ, EduNeering Holdings, Inc. has offices in Houston, TX; Bloomsburg, PA; and the UK.