Eurofins conducts various types of gynecology studies studies on women’s health care and feminine hygiene products, such as personal lubricants, feminine body washes, towelettes, tampons, sanitary napkins, incontinence products, etc. Studies may include safety assessments, evaluation of efficacy, and/or consumer opinion about the products. Eurofins CRL has Registered Nurses on staff as well as a consultant Board-certified Gynecologist who can conduct or oversee studies.
Based on the intended use of the product, Safety-in-Use studies may require an external examination of the vulvar area or internal speculum examination of the vagina. A pre-use and post-use measurement of pH may be included in the study design. For statistical relevance, it is recommended that no fewer than 30 subjects complete a Safety-in-Use study. However, the more subjects tested, the more reliable the results will be.
Efficacy studies will be designed to meet the Sponsor’s specific objective, and may include pre- and post-use weights of absorbent products or subject questionnaires for products such as personal lubricants and body washes.
Drawing on years of experience, Eurofins CRL technical staff are available to advise on study design based on the specific product and the claims requiring support.
Individual units of the test product must be provided by the Sponsor in a quantity sufficient to last each subject for the required number of uses. Eurofins CRL staff will label each unit with identifying study and subject numbers prior to distribution. Following any required evaluations, subjects are provided with the test products, instructions for use, and a daily diary in which to record each use. At the end of the specified study period, subjects return for a final examination and completion of a questionnaire, if applicable.
Reporting of Results
Following study completion, unaudited topline results may be provided verbally or in writing. All study results will be provided in an audited final report.
Scheduling a Gynecology Study
To schedule, please contact your Client Services representative at 732-981-1616 or contact Diane Dolgan at 732-393-5754 or by e-mail: email@example.com.