Infectious diseases are on the rise and we urgently need new therapies to prevent their spread. Some factors blocking successful drug development are population mobility, bacterial resistance, and rising hospital-acquired infections. Viral and bacterial infections are unpredictable, and when they emerge, speed counts.

Our team of experts have extensive practice incorporating trial optimization strategies at the design stage of each trial. We were one of the first CROs to use parallel processing to streamline operations, and we have 20 years of experience working with adaptive designs. When COVID-19 hit, we were well-positioned to meet accelerated timelines, saving time and money without sacrificing data quality and protection.

Our Experience:

• 20+ years working on infectious disease products
• 120+ infectious disease clinical project
• 85+ wound healing clinical projects
• Product types: Drugs (NCEs, botanicals, and biologics), devices, and diagnostics
• Clinical trials: 15+ (Phase I-IV), 500+ sites, 20,000+ patients
• Proof of concept through FDA marketing approval
• Rregulatory services: One 510(k), two ODD, multiple IND and multiple BLA application submissions
• Full-scope projects and targeted-scope projects
• Several rescues trials
• Five infectious disease market approvals including two NDAs, one PMA, and two 510(k)s

Therapeutic Indications:

• SARS-CoV-2
• Multi-drug resistant infections
• Prosthetic joint infection (PJI)
• Diabetic foot infection (PJI)
• COVID-19
• Debridement, antibiotics, and implant retention (DAIR)
• Respiratory infection
• Anthrax
• Ebola virus
• Marburg hemorrhagic fever (Marburg HF)
• HIV
• HIV-1 with CCR5-tropic virus
• Syphilis
• Bivalent botulinum toxoid
• Influenza
• AIDS
• MDR HIV-1
• Bubonic plague
• Toxic shock due to Staph infection
• Ventilator-associated pneumonia (VAP)
• Enterotoxigenic Escherichia coli (E. coli)
• Traveler’s diarrhea
• Onychomycosis
• Hepatitis C virus (HCV)
• Nicotine target vaccine
• Staph vaccine
• COVID-19 vaccine
• Valley fever
• Nasal Staphylococcus
• Plantar warts
• Clostridium difficile infection (CDI)
• Helicobacter pylori (h. pylori)
• Hepatitis D virus (HDV)
• Viral hemorrhagic fevers
• Malaria