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Clinical Trial Services
Criterium brings a high level of expertise, and high-value technology to every clinical trial
We customize the entire clinical research process to each client’s specific needs, from initial planning to approval. We perform monitoring tasks using proprietary technologies instead of purchasing additional costly computer hardware and software. With the use of proprietary tools (IVR/IWR, EDC, ePRO) our staff effectively manages 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 while providing the personal attention lacking in larger contract research organizations. Team members take ownership of the project and initiate actions without having to consult a committee. With fewer levels of management, our staff members can respond quickly to a client’s request.
Criterium, Inc. offers a full range of clinical research services for the pharmaceutical, medical device, biopharmaceutical, and CRO industries including:
- Full Service Research: Ph I – III, Registration and IIIb, Launch, Phase IV, & Post-Marketing
- Study Development
- Intellectual Advisory Board
- Translational Science Specialists
- Protocol Development
- eCRF Design & Distribution
- Site Management:
Solicitation, Qualification & Selection - Patient Recruitment
- Risk Management
- Regulatory Management
- IND/IDE submissions & management
- Project Management
- Study Monitoring
- TMF Management & Quality Review
- Medical Monitoring/SAE Reporting
- Statistical Analysis, Programming & Reporting
- Remote Management Tools
- IVR & IWR
- EDC Electronic Data Capture
- Bioequivalence/Therapeutic Equivalence Studies
- Comprehensive Medical Report Writing
- CTM Management
- Special Assessments
- Proprietary Investigator’s Site Database
- Automated Feasibility Questionnaires
- Medical Writing
- Data & Report Management
- Data Verification and Validation
- MedDRA & WHO Drug Coding
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 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
Our Unique Centralized Network Model (CNM) for Translational Research
Clinical Development tailored to each client’s needs
Seamless interfacing with ancillary support technologies