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Clinical Trial Services

Criterium brings a high level of expertise, and high-value technology to every clinical trial. When conducting clinical trials Criterium’s mission is threefold:

  • Provide Quality Solutions- We customize the entire clinical research process to each client’s specific needs, from initial planning to approval.
  • Reduce Costs- We perform “traditional” monitoring tasks using proprietary technologies instead of purchasing additional costly computer hardware and software.
  • Accelerate Timelines- With the use of proprietary tools (IVR, EDC, EPRO) our staff is able to speed up the process of managing clients, sites and patients.

From Thought to Finish

At every phase of development from preclinical to Phase IV, Criterium provides timely and accurate clinical trial data. This allows clients to make sound and cost-efficient decisions about safety, tolerability, efficacy, and marketability for their product. Criterium’s high-energy team is committed to achieving the highest quality results, and seeing clinical trial projects to a successful end.

Criterium’s staff has the ability to handle large-scale clinical projects while providing the personal attention lacking in larger contract research organizations. With fewer levels of management, our staff members are able to respond quickly to a client’s request and initiate action without having to consult a committee. Our team members take ownership of the project, providing clients with a more personalized, strategic approach to clinical management in the context of the phase, location, and objectives of the study.

Full Range of Services

Criterium, Inc. offers a full range of clinical research services for the pharmaceutical, medical device, biopharmaceutical, and CRO industries including:

  • Study Development
  • Intellectual Advisory Board
  • Translational Science Specialists
  • Protocol Development
  • CRF Design & Distribution
  • Site Management: Solicitation, Qualification & Selection
  • Patient Recruitment
  • Regulatory Management
  • Project Management
  • Study Monitoring
  • Medical Monitoring/SAE Reporting
  • Statistical Analysis, Programming & Reporting
  • Remote Management Tools
  • IVR & IWR
  • EDC Electronic Data Capture
  • Data & Report Management
  • Data Verification and Validation
  • MedDRA & WHO Drug Coding
  • Risk Management
  • Bioequivalence/Therapeutic Equivalence Studies
  • Comprehensive Medical Report Writing
  • CTM Management
  • Special Assessments

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

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