Effective 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 demographic data mining, scientific study design and analysis, therapeutic expertise, epidemiology and pharmacovigilance, risk management, global regulatory affairs expertise, and deep knowledge of real world 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
- Phase IV trials—approved product, same or new indications
- 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.
Data collection and management systems
i3 is on the forefront of developing integrated health care technology solutions. Available technologies include:
- IVRS
- EDC
- DataFax (optical character recognition)
- Web portal (KnowledgePort®)
- E-Clinical (web-based study management)
- ePro
- Web-based investigator training
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. |
