Investigative Site Services
- Pharmaceutical/Medical Device Clinical Trials
- Cosmetic and Consumer Product Studies
- Consumer Research
- Research Guidance Tests
- Consumer Preference or Consumer Usage
- Focus Groups
- Video testimonials/InfomercialsVideo testimonials and infomercials are an excellent addition to any marketing strategy as they provide insight
aboutwhat 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 analysisStephens 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.
Contract Research Organization (CRO) Services
- Visual Assessment Training and CertificationWe 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 DevelopmentStephens 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 DevelopmentFor 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) ManagementStephens 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 MonitoringStephens 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 AnalysisStephens 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 WritingStephens 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 GradersOur 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.
Would you like to hire Stephens & Associates for your next clinical trial?