Radiant to expand consumer products testing capabilities

Radiant Research, Inc. today announced that it is expanding its consumer products testing capabilities through creation of a new division of Radiant Research devoted to consumer trial conduct. To guide Radiant Research in this endeavor, Charles Folk has joined Radiant to head up the development of this division. Charles has over 40 years of experience in the consumer product testing industry.

"Radiant has a Quality Assurance process that is designed for the rigors of clinical trial conduct. This level of quality has increasingly become a necessity in consumer trials," said Folk. "Because Radiant follows the same stringent processes when conducting consumer trials, clients can be assured that their consumer product testing, whether safety or efficacy, will be conducted under the highest standards. Additionally, Radiant has the ideal infrastructure and support services to meet the demands of conducting consumer trials"

Radiant has 20 centers in widely differing regions of the country, enabling testing under any climatic conditions required. Radiant's recruitment infrastructure, consisting of a central Call Center and Media group, can address the very tight recruitment timelines of consumer trials. Radiant will be able to utilize its subject database of over 1 million subjects to meet these timelines. Radiant will leverage the expertise of its product development consulting division, Radiant Development, in the areas of protocol development, data management and report writing.

Asked why Radiant is focusing in this area, Julie McHugh, CEO, said: "In addition to consumer and nutritional companies looking to enhance and expand their product portfolios through well-established safety and efficacy claims, Radiant is working with Big Pharma companies who are increasingly looking at consumer products to replace diminishing portfolios due to impending patent cliffs. The Pfizer/Wyeth and Merck/Schering-Plough mega mergers, as well as the purchase of Chattem by Sanofi, and the joint venture between Procter & Gamble and Teva, all provide opportunities for these companies to claim a larger stake in the consumer products market. Rigorous scientific testing is essential in generating advertising claims. These claims can greatly enhance the market potential associated with consumer products."

The regulatory environment in the area of product claims has become much more stringent in the past few years. The Federal Trade Commission (FTC) has been pursuing action against companies making advertising claims without solid proof. Claims must have what the FTC calls "competent and reliable evidence." If the claim concerns health, safety or product efficacy, the standard is "competent and reliable scientific evidence." Companies that run ads without substantiation can incur civil penalties that can range from thousands to millions of dollars, depending on the nature of the violation.

In establishing this new division, Radiant has recently added a number of experts to the organization for the evaluation of cumulative irritation and sensitization, malodor and oral care. Radiant is in the process of cross-training and certifying additional personnel to be able to meet the staffing requirements for these types of trials. Radiant will also rely on the expertise of three of its physicians - Michael Noss, MD, Corporate Medical Director based in Cincinnati, OH, and John Murray, MD and Linda Murray, DO, investigators at the Radiant St. Petersburg site. In addition to serving as investigators on hundreds of pharmaceutical trials, each of these investigators has extensive backgrounds as investigators on consumer trials.

"Radiant has over 20 years of experience in doing consumer trial testing, but we are known for our expertise on the clinical trials side," said McHugh. "We have enrolled thousands of subjects into these types of trials. Many of us started our careers in the consumer world, so the creation of this division is a natural extension of our core business."

"Radiant has long been known within the industry as the leading provider of the highest quality data and the fastest enrollment for Phase II-III clinical trials. I am really excited about the opportunity to build on that base of existing expertise, and to be able to offer the highest quality and best service for the testing of consumer and personal health care products," cited Folk.