Arkios serves you in two functional areas: Early Stage Product Development Services and Phase II-IV Clinical Trial Management.
EARLY STAGE DEVELOPMENT - PHASE I
Our Early Stage group conceives Strategic Regulatory Plans, develops and manages preclinical / pre-IND programs, writes and files INDs and manages Phase I trials for our clients. |
CLINICAL TRIAL MANAGEMENT - PHASE II-IV
We provide full CRO services such as Clinical Trial Design & Management, Monitoring / Quality Assurance, full Regulatory Affairs consulting, Data Management, Biostatistics, Medical Writing, Investigator Recruiting, and other tasks related to clinical product development. Individual items from this list are also available per your consulting needs. |
What We Do:
Arkios guides emerging biopharmaceutical companies through all stages of product development. Whether your company is still in the university or incubator stage, or well into your clinical development program, Arkios can assist you.
We specialize in working with early-stage companies, laying out their critical path, and accelerating their progress. Many of our clients are virtual companies that are in need of assistance at every step along the path, including identification and management of pharm/tox vendors. Others bring us a clinical trial, knowing they will receive focused, individualized service and not be lost in the queue behind larger clients.
It is important for us to point out that in our 16 years of existence, we have never had a project taken from us for performance issues and have done work across a broad therapeutic range. One of the reasons for this is that we carefully select the projects in which we become involved. If we do not believe we can do a great job for you, we will not waste your valuable resources.
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. |
