Delivering precision, regulatory-grade, data insights.
Using our precision, real-world health data, we work to optimise patient outcomes by generating regulatory-grade, real-world evidence insights for pharmaceutical and biotechnology companies to support their drug discovery, development and post market approval stages of research.
How We Work
Our research database, comprising diverse data including enhanced electronic health records, unstructured data, molecular data and population data, is used to curate disease-specific datasets tailored to the needs of our pharmaceutical and biotechnology clients.
We use the research database to access and standardise these different types of extensive structured and unstructured data that are not readily available to enable our analytical team of RWE experts to generate deep, regulatory-grade insights that can support the delivery of innovative treatments for patients. The research database, known as the Real-World Data Network, has received ethics approval from the UK Health Research Authority.
Our RWE team are experts in applying both traditional and innovative real-world evidence techniques, covering research methods, medical statistics, and epidemiological approaches.
This enables Arcturis to bring real-world health data to life and deliver novel data insights including patient characterisation, treatment efficacy and clinical outcomes in the real world.
Unlike other real-world data sources, our datasets are curated in real time to ensure the data insights we generate are providing an up-to-date view of a patients journey through the health system to better inform decision making for our clients and regulators.
Strategic Solutions
Navigating the complexities of generating quality real-world evidence (RWE) requires scientific, regulatory, and technological expertise. At Arcturis, we facilitate the strategic use of RWE across the product lifecycle to support regulatory submissions and enhance decision making.
Scientific and Regulatory Expertise
Our experienced team of RWE statisticians and epidemiologists allows Arcturis to provide tailored guidance to optimise evidence generation for our clients. Our expertise ensures adherence to regulatory standards and RWE best practices to maximise the effectiveness of real-world health data and evidence across drug asset portfolios.
Our Advanced RWE Insights
Regulatory Submissions
Our real-world evidence insights are of proven regulatory grade for use in submissions to regulatory bodies. We are able to provide insights that will make a difference to achieving positive outcomes and getting innovative treatments to patients more efficiently.
Health Technology Appraisals
Health Technology Appraisals, or HTAs, are a critical step in novel drugs being adopted by the UK. Arcturis has a proven track record in successfully supporting positive recommendations from NICE through generation of RWE insights that are able to support the real-world benefits of a new treatment.
External Control Arms
Our ability to generate external control arms from the research database provides our clients with invaluable comparison data for single-arm trials, active-controlled trials or placebo-controlled trials. These data bolsters evidence packs to supporting treatment effectiveness and safety for regulatory decision making.
Pharmacoepidemiology
We describe and compare post-marketing effectiveness and safety, supporting regulatory requirements and informing formulary and pricing decisions.
Market Access
From monitoring real-world utilisation to conducting publication-ready Health Economics and Outcomes Research (HEOR), we provide comprehensive support for global value dossiers and payer decision-making and approval processes.
Post-Authorisation Safety Studies
Identifying and evaluating post-approval safety signals is essential for regulatory compliance. The real-time nature of the research database means it is uniquely placed to support regulatory obligations and ensure ongoing safety monitoring.
Natural History Studies
We conduct natural history studies to characterise specific disease cohorts in terms of demographic and clinical characteristics, treatment pathways and understand outcome risks in patients receiving standard care, informing trial design and supporting non-randomised pivotal study arguments.
Medical Writing
Arcturis’ comprehensive RWE offer includes support in medical writing, manuscript preparation and showcasing and disseminating research findings through conferences, events and invited talks.
Clinical Trial Optimisation
The research database can be deployed to optimise clinical trial design through informing better protocol design, stratifying patients by phenotypic and genetic markers, and supporting trial feasibility assessments.