With the ethnically and racially diverse subject population available at Stephens’ US testing facilities in Texas and Arizona, why would some companies choose to test their cosmetic and consumer-care products in other countries?
The answers are as diverse as the studies:
- People of different ethnicities may have different skin concerns.
- There are cultural differences in how products are used.
- Some product ingredients and effects are perceived differently in other cultures. For example, a tingling sensation is seen as negative or irritating in Japan, whereas US consumers often perceive it as a positive indication that the product is working.
- Regulations may require local testing in order to sell in that market, due in part to differences in product classifications. For example, an over-the-counter US product may be considered a cosmetic in the EU or a quasi-drug in Japan, subject to additional regulatory requirements.
As of July 2019, of the more than 300,000 studies registered on www.clinicaltrials.gov, nearly half (48%) are being conducted outside the US. About 5% are multisite, with subjects both inside and outside the US. Websites such as Centerwatch.com and www.nap.edu describe the attractiveness and challenges of conducting non-US clinical trials of drugs and devices (not cosmetic and consumer care products).
Here at Stephens, we encourage our clients to test their product in the country in which the target consumer lives. Our job is to help you manage, coordinate and monitor the study. We have developed partnerships with highly respected clinical laboratories in Japan, India, South Korea, and China that are experienced in conducting cosmetic and consumer care product studies that meet our quality standards.
To support safety testing and claim substantiation, we offer the following services:
- Study design and protocol development
- Contracting with the clinical testing facility
- Study management
- Case Report Form development
- IRB/IEC Submissions, where applicable
- Clinical monitoring
- Data management and statistical analysis
- Translation of documents and data
- Clinical Study Report writing
For additional information on international studies, contact Brooke Stephens at [email protected] or call 972-392-1529 ext. 234.