Services

Clinical Research Services

  • Pharmaceutical/Medical Device Clinical Trials
  • Cosmetic and Consumer Product Clinical Trials
  • Consumer Research
  • Research Guidance Tests
  • Consumer Preference or Consumer Usage
  • Focus Groups
  • Video testimonials/Infomercials
    Video testimonials and infomercials are an excellent addition to any marketing strategy as they provide insight about what appeals to study participants the most. Stephens has experience in assisting Sponsors in conducting infomercials and testimonials. We can schedule the study participants and provide space at our research center for filming. Sponsors can also choose to use their own filming crew or a different location of their choice.
  • Human Antioxidant and Biomarker Studies
  • Serum and biopsy sampling and analysis
    Stephens has served as a research site for clinical trials requiring serum and skin biopsy samples. After the samples are collected, we can store them as required per protocol, and ship the samples to a central reference lab we partner with or to a location the Sponsor prefers for analysis.
  • Subject Recruitment

Contract Research Organization (CRO) Services

  • Visual Assessment Training and Certification
    We have put together a certification program to train individuals on visual assessment. Stephens uses this certification program to train their PhD, MD and clinicians and also offers this certification to individuals outside of Stephens. The certification program is customized based on the needs of the client and can include a brief overview of the function of skin, background on grading scales being used, review of photo numeric scales, combination of grading of photographs and live subjects and an exam. The training is extremely useful to train individuals with no experience and to calibrate graders in multi-site trials.
  • Protocol Development
    Stephens offers protocol writing for clinical trials placed at or outside of Stephens. We can prepare the protocol using one of our templates, which adheres to applicable ICH Guidelines, a protocol customized to the Sponsor’s preference or one provided by the Sponsor.
  • Case Report Form and Study Document Development
    For data that cannot be collected through Electronic Data Capture (EDC), Stephens has template study documents and logs which can be customized to the study design or a Sponsor’s preference or we can use documents provided by the Sponsor. We can prepare any study documents for clinical trials placed at or outside of Stephens.
  • Institutional Review Board (IRB) Management
    Stephens will handle all your IRB management needs for clinical trials placed at or outside of Stephens. We partner with IntegReview Ethical Review Board and Western Institution Review Board for studies conducted at Stephens, but also have extensive experience in working with a variety of IRBs in the United States and Japan and can use one you prefer.
  • Quality Assurance Monitoring
    Stephens has its own Quality Assurance Unit that monitors your study to verify it is being followed according to the protocol and Standard Operating Procedures (SOPs), complying with regulatory and Good Clinical Practice (GCP) standards and ensure the accurate reporting of data. The Quality Assurance Unit monitors and audits each step of the study including, protocol development, compliance with all study procedures, collection of the data, case report form and source document review, statistical analysis, and clinical study report writing.
  • Data Analysis
    Stephens experienced statistics department will work with you to develop statistical analysis plans (SAP) and customized data presentations for clinical trials conducted at and outside of Stephens.
  • Clinical Study Report Writing
    Stephens provides clinical study report writing for clinical trials conducted at and outside of Stephens following ICH or ISO guidelines. We can prepare the clinical study reports using one Stephens’s templates, incorporating any sponsor preferences, or a template provided by the Sponsor.
  • Use of Electronic Data Capture (EDC) System (21 CFR Part 11 Compliant)
    Stephens has developed its own EDC system for data collection of clinical assessments during your trial to provide more efficient, quicker and timelier data analysis and topline reporting than paper case report forms. Stephens EDC has been validated as being 21 CFR Part 11 Compliant. We can also use another EDC system provided by a Sponsor.
  • Image Analysis
  • Photography Assessments by Expert Graders
    Our expert clinical graders can visually assess photographs from any clinical trial for various skin attributes. Examples include hyperpigmentation, fine lines and wrinkles, sagging, shine, redness, etc.

Clinical Research Areas of Expertise

Stephens & Associates takes pride in its ability to conduct a broad spectrum of Phase I-IV clinical trials on subject populations with a variety of diseases and conditions. Our research centers offer a variety of safety and efficacy clinical trials to help you evaluate and substantiate the safety and efficacy of your prescription, cosmetic and personal care products, devices and supplements. Each research site has their own unique area in which they conduct clinical trials and diversity of subjects.

We have experience in the following areas:

Phase I Dermatology Safety:

  • Cumulative Irritation
  • Acute Skin Irritation
  • Primary Irritation
  • Human repeat insult patch tests (HRIPT)
  • Phototoxicity
  • Photoallergy
  • Photobiology
  • Modified Maximization
  • Proof of Concept

SPF Testing

  • FDA 2007 and 2011 FDA a Monograph SPF (USA procedure)
  • ISO 24444 – Cosmetics-Sun Protection
  • Test Methods-In-Vivo Determination of the Sun Protection Factor (SPF)
  • International Sun Protection Factor –International Global Harmonization Method (SPF)
  • UVA Testing FDA 2007 and 2011 Final Monograph UVA (USA Procedure)
  • ISO 24442 – Cosmetics-Sun Protection Test Methods-In-Vivo Determination of Sunscreen UVA Protection JCIA Method (PA, PFA, PPD)
  • In-vitro UVA Critical Wavelength Analysis

Footcare

  • Bunions
  • Corns
  • Dry Heels
  • Foot pain and discomfort
  • Fungal infections (Nail)

Dermatology

  • Acne (Adolescent and Adult)
  • Atopic dermatitis/Eczema
  • Cellulite
  • Diaper Dermatitis (rash)
  • Dyschromia/Hyperpigmentation
  • Fungal infection (nail)
  • Keratosis pilaris
  • Pediatric skin treatments
  • Photodamage
  • Enlarged Pores
  • Pruritic (itchy) Skin
  • Psoriasis
  • Oily Skin
  • Rosacea
  • Seborreheic Dermatitis
  • Seborrhea
  • Striae (stretch marks)
  • Sun protection
  • Tinea cruis (adult and pediatric)
  • Tinea versicolor
  • Wound healing

Ophthalmology

  • Dry eyes
  • Self-Perceived Sensitive Eyes
  • Vision Correction/eye comfort
  • (Contact lens and eye lens
  • solutions)
  • Eye Safety/Irritation

Hair and Scalp

  • Androgenetic alopecia
  • Dandruff
  • Hair growth and inhibition
  • Scalp irritation

Specialized Claims

Examples include:

  • Firmness/Elasticity
  • Skin Lightening and Clarity
  • Texture Changes
  • Pores
  • Exfoliation
  • Fine Lines and Wrinkles
  • Moisturizes and Hydrates
  • Blood Flow
  • Body Contouring
  • % Cleansing
  • No more tears, no stinging
  • Dermatologist Tested
  • Lip Products-Plumping, feathering

Additional Areas

  • Colds
  • Irritable Bowel
  • Women’s Health products
  • Hormone replacement therapy
  • Hypertension
  • Obesity
  • Pain

Consumer Research

  • Research Guidance Tests
  • Consumer Preference or Consumer Usage
  • Focus Groups
  • Testimonials/Infomercials

Contact Us

Would you like to hire Stephens & Associates for your next clinical trial?