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

By: Criterium  11-11-2011
Keywords: Clinical Trial

  • 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.

Preclinical

  • 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

Launch

  • 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

GET TO KNOW US!

Keywords: Clinical Trial

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

Criterium’s mission is to deliver every job to every client done right, on time, and on budget. Criterium has experienced and dedicated staff located in,,,,,,, and.


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

Audit, lock, and transfer final database. On-site monitor and regulatory training.


11-11-2011

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

The new program “gives us the greatest flexibility in responding to precisely what our clients need,” says Ronny Schnel, Executive Director of Business Development. Global Contract Research Organization expands client services offerings to include an "a la carte" menu of monitoring and data management for clinical trials.