Clinical Research Services
We are a full-service Clinical Research Organization (CRO) with a strong and highly experienced scientific team that is eager to partner with industry. Inflamax Research provides a broad range of services in all areas of clinical trial research to assure the successful completion of both R&D and marketing studies. We collaborate with academia and the scientific community to continuously develop, improve and publish innovative methods, models and standards.
Phase I-IV Single and Multi-site Clinical Trial Services
Phase I Studies
Our Phase I Unit is capable of handling up to 80 subjects for studies requiring overnight stays. We are equipped with state-of-the-art monitoring systems, and combined with our experienced medical team allow for safe and effective conduct of First in Human (FIH) and pivotal early stage studies.
- Ability to conduct PK/PD studies in patient populations as well as incorporate POC inquiries
- Single ascending dose, multiple ascending dose
- Special populations
- Controlled drug/food interaction and full pharmacy
- Secure sample and document storage
- Medical screening facilities to include multiple medical and ophthalmic lanes
- Onsite and Offsite Laboratories for fast and accurate sample processing
- Full Pharmacy
- Fully Trained Clinical Research Coordinators
- Medical Writing
- Centralized Patient Recruiting Services
- Electronic Data Capture
- Data Management
- Project Management
- Clinical Monitoring and Medical Monitoring
- Global Study Coordination – including investigator site selection
- Quality Assurance
We offer regulatory services that assures the delivery of high quality customized solutions consistent with the ever evolving regulatory environment.
- Quality dossiers (i.e. Chemistry, Manufacturing and Controls)
- Electronic Compilation and submissions to IRB, Health Canada and FDA agencies
- Development and preparation of Nonclinical plans and Medical device studies
Our experienced Research and Development team of scientists can provide guidance in many aspects of drug and device development. We can help translate early molecule research to final consumer product that is possible with the combined application of controlled EEC models and well-validated quality objective sign and symptom assessment tools.
Our experts specialize in developing unique and proprietary models for your custom needs.
We can design proposals for combination studies that can incorporate Proof Of Concept (POC) ideas with mid-phase and marketing requirements to provide the maximum quality output in one study. We can collaborate with your team to strategically plan trials and are extremely skilled at working with complex designs to get them into operation. We will provide continuous scientific support and therapeutic expertise to the operations team throughout your study.
Contact us today to discuss how Inflamax Controlled Clinical Research Models may improve the cost and time efficiencies of your drug or device development program.