Clinical Trials

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Clinical trials can be a long and arduous process. It is our goal to make it as user-friendly as possible. Our staff and management team will serve as a fully compliant clinical research organization. Our operating procedures have been developed in such  a way as to provide you with the confidence and compliance necessary to meet the needs of the stringent Food and Drug Administration for clinical trial. Our protocol development, biostatisticians and clinical monitors are available to consult and prepare your documentation for clinical trial conduct.

Our regulatory expertise also includes the investigational Device Exemption (IDE) Process as well as the Premarket Approval (PMA) process. We can assist in guiding you through the regulatory approvals for your clinical trials and high-risk devices.

Please let us know if we can provide any assistance to your clinical trials process.