Pharmacometrics & PK/PD Modeling Services

EvotecAvailable: Worldwide

Integrated biostatistics, clinical data management, CDISC data standardization and PK/PD modeling to turn preclinical and clinical study data into submission-ready, decision-grade results, from early discovery through Phase III.

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Description

Every stage of drug development produces data that must be reliable, well-structured and correctly interpreted before it can support a go/no-go decision or a regulatory filing. Evotec's pharmacometrics group combines data management, biostatistics and PK/PD modeling expertise in one team. Sponsors get a single partner for handling and analyzing data, from discovery experiments and nonclinical safety studies through to clinical trials. The team works to GxP standards and applies the same quality approach to non-regulated work.

On the clinical side, Evotec supports Phase I–III trials and observational studies across many therapeutic areas, including oncology, pain, cardiovascular, respiratory and anti-infectives. Its connected workflow runs from electronic data capture to the final statistical report, which shortens timelines and reduces errors. In preclinical work, Evotec’s statisticians work alongside your scientists from protocol design to report, covering safety pharmacology, genetic toxicology, abuse liability and immunoassay studies.

Evotec’s key capabilities include:

  • Translational and population PK/PD modeling and simulation
  • Clinical NCA and pharmacokinetic analysis
  • Biostatistics for discovery, preclinical and clinical studies
  • Clinical data management, EDC and ePRO/eCOA solutions
  • CDISC SDTM and ADaM data standardisation
  • SEND datasets for non-clinical studies
  • Study design, sample-size calculation and statistical analysis
  • Data cleaning, programming and quality-controlled reporting
  • Custom analytical dashboards for preclinical and clinical data
  • Support within GxP and regulatory environments

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