Subject Recruitment
Stephens & Associates is often a leading investigational site for recruiting subjects for dermatological and women's health studies. Our success is based on a team of trained recruiters who use combinations of recruiting strategies to locate qualified subjects. S&A has an extensive computerized database of candidate subjects. Candidate subjects are identified by querying the database for demographic and health parameters outlined by the protocol. Our goal is to meet or exceed Sponsor expectations for recruiting subjects in a timely manner.

Employee and Investigator Training
An integral part of Stephens & Associates' success is our on-going training program for all S&A staff. Regular training of employees assures consistency and understanding of various methodology and ICH-GCP requirements. Employees' training and understanding are monitored in a variety of ways including written tests, observations, and interaction with previously trained staff during a study. To ensure qualified personnel in each position, S&A maintains educational or experience requirements and training files for each position in the organization.

Quality Assurance
Stephens & Associates' in-house quality assurance unit consists of top-level QA staff dedicated to working with study personnel to ensure quality data and compliance to regulatory guidelines. Studies conducted at S&A comply with Good Laboratory Practices and ICH-GCP guidelines. Our Quality Assurance Manager is a Certified Clinical Research Associate and member of the Association of Clinical Research Professionals. Our internal monitoring of study progress and study results provides our clients assurance that data generated by S&A will be top quality.

Laboratory Services
The Texas Research Center laboratory facilities are used for phlebotomy procedures and to perform various diagnostic and laboratory tests. The laboratory is equipped with a large sterilizer, a minus 70 degrees Celsius freezer, incubators, laminar flow hood, platform and analytical balances, and liquid nitrogen tanks for rapid freezing of specimens and storage of reagents. In conjunction with the Sponsor or CRO, Stephens & Associates will contract with external CLIA registered reference laboratories across the US to perform analysis of body fluids, biopsies, tissues, and microbial samplings.

Assistance in Data Management and Report Writing
Stephens & Associates is fully qualified to perform data entry and statistical analysis of study data. We have implemented an extensive computer network linking all Stephens' facilities with clients to provide updates on the progress of studies. Stephens' computer system offers the advantages of speed and the assurance that study data will not change as a result of human error. Data generated during the course of a study is double entered, verified electronically, and analyzed by statistical software that automatically generates a report. This process reduces the amount of time required to analyze data and increases the accuracy of study results. Stephens' has experienced professional writers that can draft protocols as well as final reports that comply with ICH-GCP guidelines.

Team Approach To Clinical Trials
Clinical trials are conducted at Stephens & Associates' technical research centers using a team approach. The Investigator and Sub-investigator lead a clinical team consisting of a project coordinator, a representative from the Quality Assurance Department, a subject recruiting coordinator, and clinic supervisor, and/or site manager. Through teamwork, all aspects of the clinical trials, from IRB submission to the closeout visit, are carefully executed. Depending on the study design, study visits are carried out in a block design so that most, if not all, subjects adhere to the same visit schedules. Investigators are available during work and evening hours to handle adverse events. The result is a very efficient and effective clinical study.

Types of Clinical Trials
Stephens & Associates takes pride in its ability to conduct a broad spectrum of clinical trials on pediatric, adolescent, adult and geriatric populations. Areas in which we conduct clinical trials are listed below:

	24 hour and 48 hour patch tests for accute skin irritation (primary irritation)
	14 day and 21 day cumulative skin irritation test
	Human Repeat Insult Patch Test (HRIPT) (Type IV allergy test)
	Modified maximization test (Type IV allergy test)
	Phototoxicity
	Photoallergy

Acne (Adolescent and Adult) Actinic Keratosis Androgenetic alopecia Atopic dermatitis Back pain Bacterial vaginitis Basal cell carcinoma Bunions Candidiasis Chelitis Colds Contact lens and eye lens solutions Constipation Corns Diaper Rash Dry Eye Dyschromia Eczema and rash (pigmentary changes) Genital Herpes Foot pain Hair growth and inhibition Hand eczema Hormone replacement therapy Human eye instillation/eye discomfort

Hypertension Keratosis pilaris Lice Migraine Nail fungal infection Neutraceuticals Obesity Ophthalmology Pain Pediatric formulations Pediatric skin treatments Personal hand wash products / Photoaging (sun damaged skin) Postmenopausal symptoms / Pruritic (itchy) skin / Rheumatoid arthritis Rosacea Scalp irritation / Seborrhea / Seborreheic dermatitis Skin biopsies / Skin treatment peels Sun Protection Smoking cessation Tinea cruis (adult and pediatric) Tinea versicolor Topical antibiotics Wound Healing