Non-clinical
services examples

  • Strategy
    • Non-clinical program design based on Target Product Profile, or Next Milestone Criterium
  • Content
    • Target validation plan
    • (Safety) pharmacology study plan
    • PK / PD study plan
    • Interpretation documentation / study reports / publications
    • Non-clinical registration file writing
  • Concept / content challenge
    • Assessment / gap-analysis of client study plan based on TPP / NMC
    • Refinement of study protocols
    • Due Diligence documentation
  • Process / Project management
    • Participation in multidisciplinary drug development teams
    • Management of First-in-Man dosing guidance document
    • Management of study packages /complete non-clinical programs
    • Representation of non-clinical function in clinical development team
Unrecognizable male scientist using a pharmacogenomics platform in drug discovery. Concept for pharmaceuticals, bioinformatics, pharmacogenetics, DNA, biochemistry, pharmacology, genetic makeup.
Partners Team work joining hands to success together. Business Team stack of hands for star up project. Team work Concept

Early-clinical
services examples

  • Strategy
    • Clinical biomarker plan
    • Safety / clinical pharmacology study plan
    • Advice on Proof of Mechanism studies
  • Content
    • Study protocol writing for special clinical pharmacology / POC / POM studies
    • Study results interpretation / report writing / publication writing
  • Process
    • Science Lead for mentioned studies

Regulatory & Marketing
support examples

  • Content
    • Non-clinical input for regulatory strategy & regulatory response document writing for EMA / FDA
    • Competitive edge studies plan
    • Competitive edge documentation writing