Our Approach

Steps to a Successful Trial

Stephens & Associates, Inc. has developed a six (6) step program that ensures the successful testing of pharmaceutical, devices, cosmetics and personal care products for safety, efficacy and substantiation of product performance claims in clinical research.

1

Protocol Development

Stephens & Associates, Inc. will either prepare or assist Sponsors in the preparation of protocols using Stephens’ protocol templates or a template provided by the Sponsor. Our protocols follow the ICH guidelines and contain the applicable elements outlined in E6 Guidelines for Good Clinical Practice.

2

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, Stephens & Associates, Inc. can rapidly select a subject population that will meet even the most rigorous protocol eligibility requirements. Stephens & Associates, Inc. has been successful in recruiting eligible subjects with diverse ethnic backgrounds, skin conditions and health conditions. Additionally, Stephens uses block enrollment to be efficient with the clinical trial timelines.

3

Human Perception of Product Benefit

An integral part of safety and efficacy claim substantiation is the ability to support clinical assessment and the subject’s perceptions of product benefit using objective and subjective methods.

Clinical Assessment
Our clinical graders include degreed technicians, PhD and M.D. Investigators. Investigators are trained in grading methodogy using a combination of published scales and photo numeric grading scales. Stephens’ clinical graders are calibrated and trained using the Stephens Certification Program.

Bioengineering Methods
Stephens & Associates, Inc. has a full complement of bioinstrumentation to measure blood flow rates, skin dryness, skin hydration/moisturization, skin elasticity/firmness, skin tone, fine line/wrinkle reduction, skin density, facial oiliness, skin temperature, etc. Please see a full list of our bioinstrumentation here.

Imaging and Analysis
Results of treatment changes as seen by the clinical graders and subject perception can be further documented using state-of-the-art digital photo graphic and imaging techniques including the Stephens & Associates, Inc. photostation, Hi-Scope Digital Microscope, SiaScope, Thermal Imaging, Ultrasound and Canfield systems such as the VISIA CR2, Intellistudio and Epiflash. Additional data can be collected from the photos using Stephens image analysis macros.

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, testimonials, user groups and research guidance tests.

4

Quality Monitoring and Training

Monitoring of clinical trials to ensure they adhere to the applicable FDA regulations, ICH Guidelines, the protocol and Standard Operating Procedures is a critical component in the conduct of high-quality studies. Stephens independent Quality Assurance Unit monitors and audits each step of the study from study initiation to reporting of data.  Stephens also requires and conducts annual GCP and ongoing clinical procedures training for staff involved in the conduct of the trial.

5

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. This is summarized in the protocol under statistical method and determination of sample size.

6

Final Report with Supporting Documentation

A clinical study report will be drafted using Stephens & Associates, Inc. incorporating any documented Sponsor preferences on file with the Stephens & Associates, Inc. Report Department. Reports can be written using ICH format or a non-regulated study format. The draft report will be submitted to the sponsor for approval prior to finalization, and revisions may be made at the Sponsor’s request. Electronic copies of the report are archived for a period of time as specified by the Sponsor or Stephens & Associates, Inc. standard operating procedures.