California Dermatology and Clinical Research Institute offers best in class service and policies for conducting your research trial. Our dedicated staff has over two decades of experience administering dermatology clinical research studies.
Years of Experience Running Dermatology Research Studies
California Dermatology & Clinical Research Institute (CDCRI) is an independent clinical research center with more than 20 years of experience in a broad range of clinical trials related to dermatology. CDCRI specializes in clinical research in both medical and aesthetic dermatology, across all therapeutic interventions (drugs, biologics, devices) and dosage forms (topical, oral, injectable, IV). Our experience includes studies ranging from Phase I to Phase IV safety and efficacy trials, from large multi-center studies to investigator-initiated trials, and all types of studies in between. CDCRI is led by leading clinical research dermatologist, Dr. Stacy R. Smith, who has conducted clinical trials that have led to the FDA approval of numerous advancements and innovations in dermatology. Our experienced research team is highly qualified and committed to responsible research.
The Capabilities of Our Research Institute
We have a broad range of experience in dermatologic and aesthetic trials. With this experience, we have developed a set of capabilities to match the needs of many sponsors and various trials types.
Indications Treated at CDCRI
We have performed trials across most diseases for which products have been developed in dermatology. Below are listed just a few of the many diseases for which we can perform trials:
- Atopic dermatitis
- Actinic keratoses
- Verruca vulgaris
- Male pattern baldness
- Female pattern baldness
- Alopecia areata
- Varicose veins and telangiectasias
- Localized adiposity (abdomen & neck)
We are Equipped for clinical research
CDCRI has been performing dermatology clinical research studies for many years, and we have seen it all. Our research center has all of the necessary capabilities to perform clinical research trials, but more importantly we can do the more difficult things that some trials require. Below is a list of our capabilities and assets:
- Serum or Plasma Pharmacokinetics
- Tissue Pharmacokinetics
- Prolonged Observation (12 Hours)
- Lesional and Non-Lesional Biopsies
- Gravimetric Measurements
- 24.7 temperature monitoring - room temp, 2-8 C and -20C
- Specialized Photography
- Lesion mapping and tattooing
- On site venipuncture and specimen prep
- IATA dangerous goods certification
- Imaging Studies
- Ultrasound assessments
- Stepped Cohort Enrollment
- Electronic Diaries
- Single Center Studies
- Proof of concept studies
- Phase IV or Investigator-Initiated Studies
- ACRP certified Clinical Investigator
- Certified Clinical Research Coordinators
- Dedicated data entry personnel
- Dedicated recruitment personnel
- Dedicated monitoring space with copier/printer
- Multiple board certified dermatologists for studies requiring blinded and unblinded physicians
- Experience with most of the assessment tools used in dermatology
- PASI, IGA, GAIS, EASI, SCORAD, CSSRS, SALT and many more
We Provide Feedback to our Sponsors
Like Stephen Covey said “Start with the end in mind”. We understand what a sponsor wants to see at the end of a study and what they DON’T want to see. We keep an eye out for problems DURING the trial and will let you know if we see something. We will let you know early on so adjustments can be made rather than waiting to the end and finding out there was a problem that now cannot be fixed.
We USe Only the best Study subjects
At other research clinics, you may find many potential subjects who just barely meet the enrollment criteria but are otherwise poor candidates. Their disease is really not that severe, they are not really motivated to participate in a study or they may have already demonstrated that they are unreliable.
At California Dermatology & Clinical Research Institute, we look ahead to imagine how a subject may perform in a study and consider whether they are a GOOD subject for this study. In addition, we work hard to provide a patient-centric environment that leads to reliable, satisfied subjects and maximizes study retention.
We understand the Dermatology Clinical Research process
Dr. Stacy R. Smith has served as a consultant to many drug and device manufacturers. His work has included development of scales to assess new endpoints, overall development programs as well as interaction with FDA before and during the process of FDA clearance or approval. Thus, Dr. Smith and his staff understand the development and approval process. To some sites, the regulations and requirements seem onerous; at CDCRI we know that they are a necessary part of an overall scheme.
California Dermatology & Clinical Research Institute Research Staff
A research center is only as good as its personnel. At CDCRI, we pride ourselves on having dedicated, well-trained persons doing their best to execute your trial to exacting standards. Our coordinators and research assistants have worked across multiple trials and with a variety of medications, devices or biologic agents. Many times they have had prior experience in other fields of medicine and bring that experience to bear on our dermatology and aesthetics specific trials. Typically a study will be covered by several staff members to ensure adequate coverage and manpower to see a trial through to completion. Our Principal Investigator, Dr. Stacy Smith, works closely with each staff member to ensure they have these key components required for a research staff member at any institution or clinic:
A broad knowledge of product development for dermatological research
In this way, the staff understands where the sponsor is in their development timeline and are better able to understand the goals of any particular study.
A practical understanding of Good Clinical research Practices in San Diego
Not just memorization of regulations but why things are done the way they are in clinical research.
A understanding of the Skin disease or Dermatological condition under study
In this way, they can understand the unique requirements of patients with the condition, concomitant medications that are commonly seen, why washout durations have specific lengths and much more.
A detailed understanding of the protocol & the unique requirements it may have
In research the protocol is often called “The Bible”, it helps to know it chapter and verse.