Regulatory Affairs
& Compliance
Software for Evidence Synthesis
Appeal to Evidence Across the Regulatory Landscape
Nested Knowledge enables regulatory affairs professionals to establish a single source of truth for assessing and presenting the safety, efficacy, and performance of pharmaceuticals and medical devices. Provide regulatory agencies––and your entire team––with the evidence they need using a living evidence strategy that considers the regulatory frameworks across different markets. By conducting your evidence synthesis in Nested Knowledge, from meta-analyses of clinical trial data to systematic or scoping reviews across diverse data sources, you create a single living source for all future analysis and reporting of essential regulatory data.
Safety Assessment
Evaluate the safety profile of a product by synthesizing data on adverse events, risk factors, and mitigation strategies across various populations and settings.
Efficacy & Performance
Assess the efficacy and performance by comparing your product with existing therapies or devices, using clinical endpoints, patient-reported outcomes, and functional metrics.
Quality Assessment
Appraise the quality of evidence across all reviews, with templates for a variety of frameworks and evidence types. Or, build your own templates with flexible hierarchies.
Living Evidence
Regulatory Bodies Expect Excellence
Check out this FDA Webinar featuring the ECRI Institute and the FDA’s work in the Nested Knowledge software.
Systematic reviews and meta-analyses have long been a requirement for regulatory submissions across the international regulatory landscape, such as the European Medicines Agency (EMA). However, As regulations evolve, the expectations for the quality and currency of evidence continue to rise, making it essential for regulatory affairs professionals to stay up-to-date with the latest information and methodologies.
You too can gain access to our proprietary templates which enable you to gather the right evidence now to stay ahead of the curve.
How will the Inflation Reduction Act Impact Evidence Needs for Pharmaceutical Companies?
The IRA is shaking up how drug companies and insurers set prices. Increasingly, reimbursement is now directly connected to the proven clinical efficacy of therapies. These companies–and their data providers–can take steps now to generate, store, and update evidence to prepare for health technology
New Regulations call for new strategies
How do you keep up? The future is living evidence.
As the CMS adopts the role of value-assessor (and sets the maximum price for eligible molecules), drug manufacturers will need to provide evidence supporting the efficacy and safety of their drugs, as well as the unmet clinical need. Poor evidence management, and lags in updates to evidence, will place drug manufacturers at a disadvantage to competitors.
Tools for Ongoing Analysis
Living Evidence Libraries
By centralizing all relevant data in a single, easily accessible platform, Nested Knowledge allows regulatory affairs teams to continuously synthesize in the background, while offering instant, curated access to key stakeholders.
Following the submission, regulatory agencies may have questions or require additional information. Be prepared to address these queries, provide clarifications, and submit any requested additional data or analyses more quickly than ever before.
Post-approval, keep everything up to date easily for safety monitoring, post-marketing surveillance, and periodic safety update reports.
See it in Action
Experience Living Evidence
This interactive Qualitative Synthesis visualization results from the careful combination of all currently available and published evidence for treatment of Basilar Artery Stroke with Endovascular Thrombectomy. Updated continuously in the background, this point-and-click interface allows you to review hand-picked insights, then explore the sunburst diagram or select a specific study to trace insights back to the source.
By creating the best systematic review, meta-analysis, and evidence synthesis tools available, Nested Knowledge allows you and your clients to focus on analyzing the outcomes associated with interventions and comparators across populations.
Start tracking hundreds of variables concurrently with Nested Knowledge.
Global impact
Deploy Nested Knowledge
Living evidence enables you serve all markets, both familiar and new, simultaneously.
- Safety and efficacy reviews
- Clinical trial reviews
- Comparative effectiveness reviews