Rosa & Co, LLC


PK/PD Small Graph

Streamlining Clinical Trials

Developing an integrated model of relevant sources of information – preclinical data, proprietary pharmacokinetic and pharmacodynamic (PK/PD) data, and public-literature data – plays an increasingly critical role in designing successful trials. Our clients have gained important insights from predictive drug-disease and trial simulations that are the basis for more informative and less costly trial designs – while leading to more productive interactions with regulatory bodies.

Our PK/PD modeling and trial-simulation services routinely help clients address such critical needs as:

  • Quantitatively selecting doses and dose regimens for:
    • First-in-human or dose-ranging studies
    • Proof-of-concept and pivotal trials
  • Determining the most informative a) number of active and placebo arms and b) subjects per arm
  • Assessing drug-drug interactions and their relevance to trial design
  • Evaluating and comparing alternative comparators and/or success metrics
  • Quantifying, understanding, and improving trial success probability
  • Solidly justifying dose and/or other protocol choices to regulatory agencies

Collaboratively Developed and Accurate

We work closely with client teams to increase our clients’ analytic capacity. Close collaboration also ensures that new drug-development insights and their process implications are quickly understood and incorporated. Our clients come away with a model they own, understand, and can stand behind.

Learn More

Contact us today to learn more about our PK/PD modeling and clinical trial simulation services.

Check out our case studies.