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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