RCTS offers complete clinical testing services for topical drugs and medical devices. Our team has extensive experience in the design and execution of protocols to support the safety and therapeutic benefits of topical drugs and devices across numerous therapeutic areas. The RCTS clinical team — which includes physicians/investigators, statisticians, institutional review boards (IRBs), clinical coordinators/project managers, quality control technicians and recruiters — works in coordination with the sponsor’s representative to ensure our clinical trials are expertly designed, populated with the correct subjects/patients, correctly executed and reported accurately and timely.
We approach all clinical trials with the understanding that assembling the correct team is critical for the success of the trial. Our medical investigators are all board-certified in their specialties, and all clinical staff members are trained in current good clinical practice (cGCP) regulations. All RCTS drug and device trials intended for submission to the U.S. Food and Drug Administration (FDA) are conducted in strict compliance with applicable FDA cGCP regulations and guidance documents.
Finally, RCTS will help you collect, analyze and prepare data for FDA submission and review. RCTS is highly experienced in the IRB management process and will handle preparation and submission of all IRB documentation.
With unparalleled custom study design and execution capabilities and experience spanning from Phase I (non-sequestered) to Phase IV clinical studies, RCTS will help manage your clinical testing program, with services including:
- Budget preparation
- Protocol development
- Project management
- Site management
- Patient recruitment and retention
- Data management – including working with Sponsor’s Electronic Data Capture (EDC) or through third party EDC.
- Statistical programming, analysis and reporting
- IRB document preparation and submission
- Interim analyses
- Clinical study report
- Quality assurance
- Quality control
- Safety management
Works with EDC vendors to establish part 11 compliant platforms.
Areas of Expertise
- Diaper dermatitis (rash)
- Pediatric skin treatments
- Enlarged pores
- Pruritic (itchy) skin
- Oily skin
- Seborrheic dermatitis
- Stretch marks
- Wound healing
Hair and Scalp
- Hair growth and inhibition
- Scalp irritation
Women’s Health and Gynecological Products
- Gynecologists can perform evaluations for vaginal pH, presence of vaginal microbes, incontinence, performance of menstrual products