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Natural History Studies
Utilise observational data to characterise the untreated progression of a disease, establishing a reference for treatment efficacy assessment
Real-World Evidence for Regulatory Submissions
Reduce drug development timelines, lower costs and make informed decisions using RWE
Regulatory Use Cases
External Control Arms
Employ real-world data from external cohorts to serve as controls in single-arm trials, enabling comparison with treated groups by using untreated patients or those receiving standard care as comparators
Supplementing Randomized Clinical Trials
Integrate RWE with randomised RCT data to augment safety and effectiveness evaluations, addressing specific regulatory questions
Providing Primary Evidence
Leverage RWE as a core data source for regulatory strategy
Supporting New Indications
Use RWE to identify and prioritise indications as well as maximising PTS through integreated clinical development strategies
Supporting Post-Approval Studies
Utilise RWE to meet regulatory requirements for ongoing safety and effectiveness monitoring post-market approval
Our formula for RWE in regulatory submissions
At Inovia Bio, we leverage our proprietary technology and regulatory expertise to create personalised solutions for each of our partners.
Collaborative Discovery
We start by working closely with your team to deeply understand your unique challenges and desired outcomes, laying a solid foundation for a tailored, data-driven strategy.
Rapid Evidence Alignment
Within just 7 days, we deliver an Integrated Evidence Plan via InovaIEP that aligns all stakeholders, identifies critical evidence gaps, and defines the precise data needed to support your asset’s regulatory journey.
Swift Data Identification
Using Inova360, we identify the necessary regulatory-grade RWD to support your submission in minutes, ensuring speed and precision every step of the way.
RWE Data Analysis
With InovaMine, we maximise your RWE data, transforming it into actionable insights that empower you to make informed decisions and strengthen your program
Regulatory Expertise
Our experienced Medical Team guides you throughout the regulatory process, proactively identifying potential issues and ensuring a seamless path to success.
Try Our Free RWE Study Designer
Design RWE studies in Minutes, specifically outlining the windows for assessing various aspects of the study cohort