Clinical Pharmacology + Consulting

|Clinical Pharmacology + Consulting
Clinical Pharmacology + Consulting 2017-06-30T19:57:16+00:00
What We Do

Preserve your study timelines with expert review and analysis of complex data.

The ability to predict reliable human response to investigational products by reviewing and cultivating minimal data sets requires unique and precise expertise. Our Clinical Pharmacology team helps bridge the gap between nonclinical and clinical data, leading to extrapolation of response into the larger population. We offer an experienced and knowledgeable team with extensive agency exposure to generate and support everything from program-level strategy, formulation of pharmacology documents, to plan operations and implementation.

Clinical Pharmacology and Consulting experience you can count on.

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Analyses defended in front of regulatory bodies
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Small molecule and biologic trials completed
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PK analysis plans prepared

Count on our clinical experience, regulatory expertise, and proven industry reputation to help you address:

  • Nonclinical and clinical development support including pharmacology, toxicology, pharmacokinetic studies, biopharmaceutical, and ADME programs
  • Bridging support between nonclinical and clinical data sets
  • Extrapolating minimal data into human response prediction
  • Calculating proper dosing and sampling
  • Defending exposure-response modeling in front of global regulatory bodies
  • Strategizing program management of your small molecule, biologic, and immunoresponse clinical trials
  • Writing specialized pharmacokinetics/pharmacodynamics publications, protocol design, biopharmaceutics summaries, briefing books, and all related study documents
“Firma has a well-known team of some of the most reputable industry experts. They bring a level of strategy that we simply didn’t have internally.”

Learn how three clients relied on Firma Clinical Pharmacology & Consulting to assess project data and deliver recommendations ahead of schedule.

Want to learn to how we can preserve your study timelines with expert review and analysis of complex data?

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