Criterium Inc.- CRO Clinical Research, Clinical Trials, in USA Europe South Africa India

By: Criterium  09-12-2011
Keywords: Clinical Trials

Criterium Inc.- CRO Clinical Research, Clinical Trials, in USA Europe South Africa India

  • Reduce Costs- We perform “traditional” monitoring tasks using proprietary technologies instead of purchasing additional costly computer hardware and software.

From Thought to Finish

Clinical Trial Service Expertise

In addition to a full suite of services across the drug development timeline, Criterium provides specialized services at each trial juncture. Since 1991, Criterium has been developing programs that serve clients’ needs to get the job “Done right and on time!” Clients can choose the service that meets one or all of their requirements.


  • Clinical development planning
  • Regulatory consulting
  • Protocol design
  • Expert panels

Phase I

  • First introduction into man
  • PK/PD studies
  • Single-dose, multiple-dose, and dose-escalation studies
  • Special studies (e.g. food interaction; skin irritation)

Phase II

  • Proof-of-concept studies
  • Dose-ranging studies

Phase III

  • Large-scale global safety and efficacy studies
  • Placebo-controlled studies
  • Active-comparison studies
  • Bioequivalence studies with clinical endpoints
  • Quality-of-life studies
  • Resource utilization studies

Registration/Phase IIIb

  • Individual study reports
  • Integrated safety and efficacy summaries
  • Treatment INDs
  • Package inserts
  • Submissions in NDA or CTD formats
  • Biostatistics


  • NDA supplements
  • Continuing Phase IIIb studies

Phase IV

  • Post-approval regulatory commitments/support for primary indication
  • New indication studies/labeling expansion
  • Product/disease registries
  • Health-related quality of life, patient-reported outcomes via IVRS
  • Post-marketing surveillance
  • Retrospective chart reviews
  • Managed-care studies
  • Pharmacoeconomics

Keywords: Clinical Trials