Protocol & Study Design

protocol design clinical trialsCROS NT’s expert clinical team supports Sponsors with their overall clinical strategy and development including the planning, design and execution of product development.

Early Phase Clinical Trials (Phases I/IIa)

CROS NT’s clinical experts have extensive knowledge and expertise in Early Phase clinical trials and can provide clinical and strategic product development advice and consultancy regarding study design and selection of suitably qualified Phase I units.

Our consultancy includes:

  • Protocol Development
  • Study Document Development
  • Study Monitoring
  • Medical Safety Monitoring
  • Bioequivalence/Bioavailability
  • Proof of Concept
  • Pharmacokinetics/Pharmacodynamics
  • First in Man
  • Safety & Tolerability
  • Special “population groups”

Late Phase Clinical Trials (Phases IIb/III/IV)

protocol design late phase trialsWith our full range of clinical, regulatory and biometrics services, our clients gain end-to-end project planning to build quality into their clinical trials from the start – with mitigating risk strategies and efficient and effective time and budget planning.

CROS NT’s highly experienced clinical operations team provides strong site management and patient enrollment strategies based on well-researched evidence-based feasibility assessments. We utilize expert medical monitors to provide important oversight of safety during trials.