RCTS provides testing services for the pharmaceutical, cosmetics and consumer products industry in two categories: safety and claims substantiation. Safety testing consists of a variety of patch studies and safety-in-use studies. Claims substantiation and efficacy studies are designed to evaluate marketing claims (such as reduction in fine lines and wrinkles, increase in skin moisturization, non-comedogenic, non-acnegenic, etc.). These studies can be simple in design and of short duration, or they can be complex, long-term studies requiring multiple visits to the testing facility, with both expert clinical grading and instrumental measurements and statistical analyses. For pharmaceuticals, cosmetics and consumer products, trust RCTS for superb execution and clear results.
Safety Testing
Protocols designed to determine the safety of topical products and that are acceptable to both regulatory agencies and to industry.
Safety-in-Use Studies
Determining product safety under normal or exaggerated use conditions.
Patch Studies
Human repeat insult patch tests (HRIPT) for contact sensitization/irritation and acute and cumulative test for irritation.
Claims Substantiation and Efficacy Testing
Studies to evaluate effects of topical product to support marketing claims.
Questionnaire Design
Subjective assessments of the performance and physical attributes through self-assessment questionnaires.
Data Management
Established procedures for completion of source documents and CRFs. 100% data check of all clinical trial records. Experienced with data capture using electronic data capture (EDC).
Patient Recruitment
Large database maintained in-house to identify and recruit individuals who meet study-specific inclusion/exclusion criteria. Other recruitment strategies include website postings, social media, print media, radio and television.
Source Documents and Case Report Forms
Well-written, targeted source documents and case report forms (CRFs).
Budget Preparation
Expert in the preparation of clinical trial budgets, which are prepared with the full understanding of the price-competitive nature of clinical trials.