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Clinical Trial Services

As a global contract research organization with the goal of offering a unique mix of high-quality innovative clinical research services, Criterium provides a high level of expertise, high-value services, products, and technologies, and high-end results to the pharmaceutical, biotechnology, and medical-device industries. Criterium’s mission is threefold:

  • Accelerate Timelines through our experienced management team and proprietary tools (IVR, EDC, EPRO) to manage clients, sites and patients.
  • Reduce Costs by transforming “traditional” monitoring tasks through proprietary technologies without the additional purchase of expensive computer hardware and software.
  • Provide Quality Solutions for the entire clinical research process, from initial planning to approval, which can be customized to fit each client’s specific needs.

From thought to finish, Criterium transforms timely and accurate clinical trial data at every phase of development — preclinical to Phase IV — into information that allows clients to make sound and cost-efficient decisions about safety, tolerability, efficacy, and marketability for their pharmaceutical, biotechnology, or device products. In addition to cutting-edge clinical trial technologies – interactive voice response, electronic data capture, and electronic patient diary – Criterium’s competitive advantages include high-energy teams, a commitment to achieving the highest quality results, and perseverance to seeing clinical trial projects to a successful end.

Criterium’s staff has the ability to handle large-scale clinical projects from site and patient recruitment, study initiation and closure, to data acquisition , analysis, and reporting — 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 in real time, 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; understand trial design; embrace the importance of defining best practices; and are adept at resource planning in the context of the phase, location, and objectives of the study.

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 study management process 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

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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