Clinical Trial Background

Therapeutic Area: Dermatology
Years of Clinical Trial Experience: 24
Total number of clinical trails as of February 2024: 500
Number of trials performed in the last 5 years: 150+
Average number of enrolled subject per study compared to forecasted: 80%
Approximately how long does it take to finalize Clinical Trial Agreements? 4-6 weeks

Number of Trials
Phase I: 40
Phase II: 160
Phase III: 210
Phase IV: 80
Pharmcokinatic (PK): >200
Pharmacodynamic (PD): >150
Bioavailability (BA/Bioequivalence (BE): 15

Staffing-Investigators
Primary Investigators: Scott Fretzin, MD (CV Link), Kenneth Dawes, MD (CV Link), Michael Sheehan, MD (CV Link)
Degree: MD
Board Certified: Yes

Number of Sub-Investigators: 13

Staffing-Study Coordinators

Number of Study Coordinators: 8
Number of Regulatory Coordinators: 1

Do you have experience with Electronic Data Capture (EDC)?: Yes
Have you been audited before? No

What clinical training has the staff received?

• GCP
• CITI
• IATA
• SAE Reporting
• 21 CFR Part 11
• HIPAA
• Informed Consent