Clinical Special Studies
Clinical testing facilities commonly offer their clients a full array of industry-standard pre-market clinical testing to measure product efficacy and to help ensure consumer safety. These tests usually involve panelists’ observations and opinions about the product in use, and results of measurement and evaluation techniques. For manufacturers of products in established categories making familiar claims, these common clinical tests may be sufficient to provide the data needed to support the product.
But often manufacturers want to go beyond standard testing protocols to evaluate an innovative new product, to substantiate very specific claims, or to provide quantitative safety data. Such specialized testing requires more sophisticated methods requiring targeted expertise and precise instrumentation. CPT has the expertise, the facilities, and the technology to custom-design a special study to meet your unique product testing goals.
While general clinical testing is commonly conducted as a matter of course near the end of the product development cycle, more specialized studies can influence the development cycle as well as inform marketing plans. Because of their individualized nature and more sophisticated methods such as bio-instrumentation, special studies take more time to develop and conduct. All of these factors are significant in clinical special studies:
- If the study anticipates any regulatory review or scientific publication, the protocol will need the approval of an Institutional Review Board (IRB) before any testing is begun. IRBs function to ensure the well-being of panelists. Significant pre-clinical testing should be undertaken prior to requesting an IRB review, and strict application requirements must be met.
- Special study panelists are carefully vetted against more precise inclusion and exclusion criteria. For a sunscreen study, for example, panelists might need to be of a particular skin type and have no detectable base tan. For a wrinkle cream study, the protocol might require panelists with a given level of skin aging or other damage. Current medications, activities, known allergies and sensitivities, sleep habits, acne or other skin lesions: any number of circumstances may be important to gathering useful data through a special study.
- Special studies often involve board-certified professional consultants such as medical doctors (dermatologist, pediatricians, etc.), ophthalmologists, or dentists. These consultants may be directly involved in conducting the study, such as taking measurements or making evaluations. They may take part in developing the study protocol. They may simply be on-site during a study to oversee operations generally. In any case, our relationships with these professionals rely on careful coordination and scheduling among CPT, professionals, and panelists.
- Special studies’ testing is likely to extend over longer time periods. Some common studies require one or two visits to CPT. Many special studies, on the other hand, take 8 to 12 weeks, or longer, for data collection and analysis to show a product’s effects on the user over time, with repeated use, or in use according to a recommended regimen.
- Interpretation of special study results is usually more complex. Our in-house data professionals and statisticians assist with study design and later compile and analyze study results. CPT will help you interpret those results into information you can use to support your product.
Involving CPT in the early stages of product development will allow us to work closely with you to design a product testing strategy that provides objective inquiry into the safety and efficacy of your product while also supporting your business by respecting timelines for NDAs, labeling, advertising, and other regulatory considerations and collateral key to launching a new product.
To learn more about Clinical Special Studies at CPT or to get started on a special study for your product, please contact us.
CPT has state-of-the-art analytical, microbiological, clinical, photobiology, and in-vitro toxicology testing laboratories, all of which are at your disposal in the determining of product safety, efficacy and efficiency.
Using our specialized departments and well-respected lab facility, we test a wide range of products at CPT. Our in-house experts offer guidance to determine the efficacy of your products while ensuring compliance and accommodating your budgetary concerns.
For dermatological studies to ensure product safety, CPT offers:
- Human Repeat Insult Patch Test (HRIPT)
- 48-Hour Patch Test
- Cumulative Irritation
- Facial Sting
- Visual and Tactile Grading
For dermatological studies to ensure efficacy claims, CPT offers testing to confirm the following.
- Moisturize Retention and Hydration Capacity
- Cosmetic and Acne concerns
For hair care studies to ensure efficacy claims, CPT offers:
- Trichological (Hair Count) Analysis
- Hair Shedding Assessments
- “Hair Pluck” Test
- Tensile Strength
Based on the individual needs of our clients, we offer a wide range of support across various departments. Since initial product testing can be fairly complex in terms of a high-quality, safe and trusted product, our clients typically explore the benefits of numerous departments and areas of expertise, including:
- Clinical — Testing can be performed for safety, consumer in-use, and to support claims, such as ‘dermatologist-tested’ and ‘ophthalmologist-tested.’
- In-Vitro Safety — Our in-vitro safety department assists clients when they are looking to perform non-animal or animal-free toxicology testing.
- Microbiology — Microbial contamination and preservative testing is key to cosmetic products.
- Photobiology — From SPF and Water Resistant claims to PhotoAllergy and Phototoxicity studies, CPT is the world leader in sunscreen testing.
- Analytical — From raw materials, batch release, and stability shelf-life testing to “free-of” and low-level detection claims, our analytical department ensures that all requirements are met based on industry standards.