Biotechnology - Virginia Beach, VA, United States
Arkios s a full service global biopharmaceutical clinical research organization (CRO) and consulting group in Virginia Beach, VA providing contract research services to emerging technology companies developing new drugs, biologics, medical devices, and diagnostics. Arkios focuses on assisting emerging biopharmaceutical and device companies with the early stages of regulatory strategic planning and implementation as well as in the filing of a successful Investigational New Drug/Investigational Device Exemption (IND/IDE) with the FDA. We also design and manage the clinical development of emerging technologies in the biopharmaceutical and device areas through successful product out-licensing or registration. ARKIOS Can Serve You With: • Outsourcing a specific clinical trial management function. • Comprehensive regulatory affairs assistance. • Data management & biostatistics. • Recruiting clinical research sites. • Seeking early stage product development guidance in approaching the FDA. We specialize in the following areas: Dermatology including Wound Healing, Infectious Diseases, Oncology, Gene Therapy, Plasma Products, Vaccines, Diabetes, and CNS. We also work with Diagnostics and Medical Devices. We also work with clinical research centers to provide outpatient Phase I Vaccine Safety and Immunogenicity testing.
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