Successful regulatory approvals require appropriate planning and execution of a scientifically robust and compliant device development strategy. This strategy must be supported by a deep understanding of the regulatory landscape and detailed analysis of available options. Validation plans, developed using state of the art statistical methods that support the scientific hypotheses, are key to optimising study designs and reducing cost and time for clinical validation.
Our biostatistics collaborators specialise in developing and applying innovative analytics solutions that let us and our clients derive more information from data collected in clinical investigations, performance studies and electronic health records. Using a unique proprietary platform allows us to anticipate and overcome barriers to a successful clinical development plan, allowing our sponsors to maximise the chances of a positive study outcome.
Bespoke end-to-end biometrics services from strategic decision support and protocol development to analysis and reporting, creating smarter protocol designs and driving overall stakeholder engagement.
Statistical Analysis Planning
Our biostatistics group work with sponsors and manufacturers in the development of an SAP that supports the overall performance objectives of the investigational device. We support our clients in alignment meetings with global regulators to explain the statistical rationale that will support the required performance for the device in the clinical setting.
Clinical Protocol Development
In collaboration with our biostatistics partners, we develop clinical investigation protocols and clinical performance plans that are scientifically sound, meet the needs of all stakeholders and yield clinical data that is robust, verifiable and demonstrates the study objectives.
- Clinical protocol design that maximises the potential for recruitment and retention of study participants
- Smart statistical planning and data modelling seeks to ensure that study data supports the objectives and endpoints
- We work to deliver a successful and streamlined product launch to market
ARC Biostats Team
- Are experts in medical device research, ensuring stakeholder alignment on robust, scientifically sound clinical investigation plans.
- Accelerate precision medicine development using leading-edge statistical and computational methods that support and expedite genomic discovery, focusing on biomarker discovery and validation, companion diagnostics development and the integration of biomarkers into development programmes.
- Employ proprietary software, we accelerate Precision Medicine studies through the optimisation of a wide range of study parameters and support multiple sub-group and treatment group identification.
- Have significant experience in FDA alignment meetings on medical device and in vitro diagnostic statistical approaches and methods