Clinical Trial Services
From thought to finish, Criterium
provides timely and accurate clinical trial data at
every phase of development allowing you to make sound
and cost-efficient decisions about safety, tolerability,
efficacy, and marketability for your pharmaceutical,
biotechnology, or device product. Our competitive advantages
are high energy, commitment, and perseverance.
CLINICAL TRIAL SERVICE EXPERTISE
In addition to a full suite of services
across the development timeline, Criterium provides
specialized services at each trial juncture:
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
- Quality-of-life studies
- Resource utilization
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Registration/Phase
IIIb
- Individual study reports
- Integrated safety and efficacy
summaries
- 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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