INSIGHTS ON CLINICAL TRIAL PARTNERING

CLINICAL TRIAL PARTNERING SOLUTIONS

  • A CDMO with the right team of experts can aid drug development, regulatory compliance, and clinical trial supply, accelerating timelines to first human dose clinical trials and the path to market.

  • PCI's team of qualified persons assume responsibility for all stages of the process, safeguarding patients including the audit of the supply chain for GMP compliance in addition to certification of products for use in clinical trials.

  • A generic drug must contain the same active ingredients as the original formulation. According to the U.S. Food and Drug Administration (FDA), generic drugs are identical or within an acceptable bioequivalent range to the brand-name counterpart with respect to pharmacokinetic and pharmacodynamic properties.

  • Did you know that patient recruitment is the #1 cause of trial delay? Biorasi recruitment solutions succeed where others stumble. Read more about getting studies back on track and ending enrollment delays.

  • Australia is a preferred destination for early phase trials because of simple and fast regulatory stream and lucrative R&D cash refund scheme.