Evidence and experience-based solutions
i3 Innovus is a world leader in health economics, outcomes, and late phase research. We uniquely couple expert study design consultation with rich datasets to enhance the success of late phase studies, helping you achieve both your scientific and commercial objectives while maintaining regulatory compliance.
A multifaceted approach
Efficient execution of late phase research requires a multifaceted approach that involves adaptive late phase operational approaches, automated technology solutions, scientific study design and analysis, therapeutic expertise, epidemiology and pharmacovigilance, risk management, global regulatory affairs expertise, and deep knowledge of real world research.
i3 Late Phase Research clearly understands these multifaceted approaches and possesses the necessary expertise and technology to optimally conduct this specialized research.
Wide-ranging late phase research capabilities
i3 Innovus specializes in the design, implementation, and results dissemination of the following types of late phase research:
- Registries—disease, product, and safety
- Post marketing observational studies
- Phase IV trials—approved product, approved or new indications/labeling expansion
- Clinical effectiveness trials
- Consumer healthcare/OTC trials
- Community-based and naturalistic studies
- Health economic and outcomes research (prospective, observational studies)—cost-effectiveness, burden of illness, PRO/QoL, chart review, survey (direct to physicians or patients)
- Health economic piggyback trials
Leveraging unparalleled data assets
Our late phase research team has access to secondary data assets that can be leveraged to facilitate robust study design and streamline study execution. This data can be analyzed to determine/confirm sample size; assess/improve study protocol feasibility; identify targeted investigators and patients; and improve the efficiency of recruitment and execution of the study.
Clinical trial and data management with i3Cube™
i3Cube is a Web-based, fully integrated clinical trial and data management system that provides global, end-to-end project and data management connectivity between sponsor, sites, and CRO, allowing the entire team to remain engaged every step of the way—and elevating client control to a new level in clinical research. By consolidating all aspects of the clinical trial process from site selection to final data delivery, i3Cube can greatly increase team efficiency and effectiveness. i3Cube also keeps all late phase trial constituents integrated to mitigate risks and help users stay on schedule and on budget.
Remote site management
i3 Innovus also offers sponsors a site management center (SMC) comprised of in-house CRAs to manage investigator sites remotely, cost-effectively, and in a manner designed to maintain data integrity. Its dedicated staff can assist with regulatory document collection, IRB approval, protocol training, patient enrollment, data submission and cleaning, and any other site needs. The SMC can also provide full central monitoring or traditional on-site monitoring via certified CRAs, depending upon trial requirements. |
