S&A has developed a unique five-pronged multidimensional
approach that ensures the successful substantiation of product performance
claims in clinical research.
Subject Selection
The success of a clinical trial is dependent on the appropriate screening and
selection of subjects. Using its trained recruiters and a computerized database
of subjects, S&A can rapidly select a subject population that will meet
even the most rigorous protocol eligibility requirements.
Human Perception of Product Benefit
The subject's perception of how a test product performs is a highly relevant
dimension in product testing. Subjects' perceptions of product benefit
can be captured through the use of study questionnaires, focus group interviews,
and research guidance tests.
Clinical Assessment and Documentation
Photography
Our clinical graders include degreed technicians and Ph.D.
and M.D. Investigators. Investigators are trained in grading
methodology and ICH-GCP guidelines. Results of treatment
changes as seen by the clinical graders can be further
documented using state-of-the-art digital photographic techniques including Canfield
and custom designed equipment.
Non-Invasive Bioengineering Methods
An integral part of claim substantiation is the ability to support clinical
assessment and the subject's perceptions of product benefit using objective biophysical
instrumentation and methods. S&A has a full complement of bioinstrumentation
to measure blood flow rates, skin dryness, skin hydration/moisturization,
skin elasticity/firmness, fine line/wrinkle reduction, skin oxygen levels,
skin thickness, facial oiliness, etc.
Statistically Based Conclusions
Data analysis is as important as experimental design and execution in determining
the success of a study. Analysis methods are chosen that extract the most
information from the data and therefore provide the most general inferences.
The choice of analytical method depends upon informational goals and fundamental
data characteristics.