Clinical Research Trials Unit
Fast Study Start-up
- On-Site Institutional Review Board
- Monthly meetings for IND, NDE studies
- Expedited review available for non-FDA studies
Rapid Enrollment
- Continually expanding database (8,000 subjects)
- Quick identification of protocol- specific subjects
- Varied recruitment methods (internet, newspaper, radio, Fax)
- Ability to reach targeted population
- Off-Site recruitment and study conduct capabilities:
- Puerto Rico
- Indiana
Dedicated Resources - Clinical Sites
- Oral Health Research Institute
- 10 operatories
- Secure product storage - all temperatures
- Secure records storage
- Additional Research Facility
- 3,600 sq. foot facility with 3 operatories
- Lounge area for subjects' use in all-day studies
- Dining/kitchen facilities
- Laboratory
- Secure product/records storage
Dedicated Resources - Faculty and Staff
- Full-time and part-time dentists and physicians dedicated 100% to research and trained in GCP/ICH regulations and guidelines
- Six clinical research coordinators, with a minimum of five years experience
- Three Certified Clinical Research Coordinators (CCRC) by the Association of Clinical Research Professionals.
- Infection Control Manager and three assistants
- Recruitment staff
- Dedicated Biostatistical Support through the Indiana University School of Medicine
Types of Clinical Trials
- Product Development
- New Methodology Development
- Safety, Efficacy, Claims Substantiation, Comparison Studies of Oral Products
- ADA/FDA Guideline Studies
- Phase I, II, III, and IV
Therapeutic Area Expertise
- Clinical Caries Trials (large and small-scale)
- In Situ models for caries, stain, plaque
- Gingivitis and plaque studies
- Calculus prevention and removal studies
- Stain prevention and removal studies
- Periodontitis studies
- Whitening/Bleaching studies
- Smoking cessation studies
Study Development and Statistical Support
- Protocol and study design development and review
- Sample size calculations
- Randomization
- Data analysis
- Statistical reports
On-Site Infection Control/Sterilization
- Full-time staff
- Certified Registered Central Service Technicians (CRCST)
- Flexible Scheduling
Quality Assurance Program
- Quality Assurance auditor on staff
- GCP/GLP training for all staff
On-Site Microbiology Facility
- Fully-equipped laboratory
- Anaerobe Chambers
- Spiral Platers
- Safety and efficacy studies for ADA, FDA, and Claim Support
- Crevicular Fluid Collection and Analysis
- Specialized Analysis
- Dark-field/Bright-Field Microscopy
- Biofilm Analyses
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