Radiant to launch new division with dermal safety study

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As part of their ongoing growth strategy, Radiant has been expanding its capabilities into the Consumer Products Testing arena. In order to supplement the existing Radiant staff that has years of consumer products testing experience, Radiant has hired key technical experts to serve as Study Managers, and to assist in training and certification of personnel. Additionally, SOP and work practices have been developed for the conduct of consumer trials at the Radiant sites.

“the decision to use Radiant to open the IND was based on Radiant's extensive expertise and previous history of success with a variety of clinical trials.”

Radiant was recently approached by an international sponsor seeking a development partner for a unique topical formulation that requires an FDA mandated dermal safety study to open their IND. The technical expertise of the personnel at Radiant's St. Petersburg, FL location, coupled with Radiant's strong track record of executing clinical trials with adherence to the strictest ICH/GCP guidelines, made Radiant the right choice for this partnership.

Dr. Eve Del Rio, MD, Ph.D., President of Rio Pharmaceutical Services and liaison for the sponsor on this program said "the decision to use Radiant to open the IND was based on Radiant's extensive expertise and previous history of success with a variety of clinical trials." Dr. Del Rio mentioned that "we needed a partner that truly understood the nuances of dermal safety testing and the evolving regulatory requirements, and had a solid quality reputation." Radiant is currently in the process of recruiting for the study, and will begin study conduct by the end of September.

Radiant decided to launch its new Division with a dermal safety study because it best fit the organization's capabilities given their dermatological experience and recent staff additions. Radiant has a long history of conducting safety trials, and its CRO division has provided management of over 200 pharmaceutical trials, including many safety studies. "We plan to offer the entire dermal safety package to the industry, including Phototoxicity/Photoallergy," said Julie McHugh, CEO of Radiant. "In terms of dermatologic product development, Radiant is equipped to offer what other existing laboratories struggle to do - early stage dermal safety testing, as well as the follow-on Phase II and Phase III clinical trial testing required for drug approval. Radiant is already known as a leader in the later stage testing. Adding the complement of the dermal safety package gives our clients the efficient and economic option of working with one partner for an entire clinical development program," added McHugh.

Radiant has plans to continue the expansion of its Consumer Products Testing Division. In addition to dermal safety testing, the company will be focusing on the areas of safety testing and claims support for personal care products, initially concentrating on skin care and feminine hygiene products. Radiant is currently evaluating further technical hires and instrumentation necessary to meet customer requirements. "We are committed to this effort," stated McHugh. "We are taking a very pragmatic approach to expanding our services. We have the reputation of providing the highest level of service in the clinical trials space, and we are ensuring we maintain that reputation by having the training and expertise in place before taking on any consumer work. All systems are in place for this dermal safety study and we are confident that our performance will make us the industry leader in this type of trial. It is this careful and honest approach that our pharmaceutical client's count on when they award a study to Radiant. We want our consumer product clients to have this same confidence in our abilities."


 Radiant Research, Inc.:


The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
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