Digital measurement tools have opened a world of possibilities in remote clinical research, and Koneksa is dedicated to the continuous discovery, testing, and implementation of at-home digital solutions designed to advance human health.
Biomarkers have been part of clinical research for many years. There are different types and different development methods that govern their qualification, such as the Evidentiary Framework. The use of digital tools to collect disease measures remotely — Koneksa’s primary area of expertise — is what differentiates digital biomarkers from their non-digital counterparts.
Leading the Remote Digital Data Collection Revolution
Koneksa is at the forefront of digital biomarker development, validation, and deployment. Such work comes with high expectations and is governed by regulatory authorities, which is why we do the research to ensure the quality and validity of the measures we deploy in our solutions.
Through historical and ongoing R&D and support of biomarker and outcome measures, we have developed deep expertise needed to provide measures that characterize disease and the impact of your treatment. We put our experience to work for you in close, early collaboration, ensuring you get exactly the solution you require.
What Digital Biomarkers Can Tell Us
Biomarkers are measures of key characteristics that indicate normal biological processes, pathogenic processes, or responses to treatments and other forms of exposure or interventions — HbA1c for measuring average blood glucose over 3 months, for example. In the age of digital transformation, however, the variety of methods available for characterizing disease and health status has increased exponentially, with new approaches and wearable medical monitoring devices emerging almost constantly. Digital wearables and sensors can help identify new disease measures that were previously impossible to readily measure outside a clinic.
Determination of the target biomarker is an early and important decision for sponsors to make. Several types are defined by the Evidentiary Framework:
detect disease presence
likelihood of a clinical event
Biomarker type drives the evidence and validation approach. Similar requirements apply to the development of outcome measures, but with the addition of a requirement to demonstrate content validity.
Validation requirements are defined by industry frameworks, such as V3 and regulator Evidentiary Framework. Developing a validation approach with evidence is what we help you do.
Our Framework for Characterizing Digital Biomarkers
Over the course of numerous projects, we have developed a generalized engagement approach that helps sponsors develop novel digital biomarkers and outcome measures. This approach can be tailored to your needs and adapted based on available evidence. If you have completed work, that can also be incorporated into a project plan.
Why Do We Focus on At-Home Measures?
Because you need to know the impact of a disease or treatment as patients go about their daily lives, not just during occasional visits to a trial site. Further, not all patients have ready access to a study site, and some have diseases that make travel a significant burden. Remote digital measures happen in a context that is less burdensome to patients, and they can occur more often than in clinical visits.
We provide a better way to collect clinical data.
Koneksa Sets a Higher Standard for Digital Technologies
Digital biomarkers have tremendous potential to help us understand patients’ underlying physiological processes and how those functions interact with treatments. We put science first, and to ensure you derive high-quality, actionable data from our solutions, Koneksa holds the digital devices and technologies we use to industry and regulatory standards, applying the same scientific methods used to develop and validate wet or imaging biomarkers.
We do not offer consumer-grade solutions
Each component of a Koneksa solution functions as intended and meets the needs of your trial better than other available options. Scientific rigor is the foundation of all that we do, and we spend the effort to ensure our offerings capture the measures that matter for your trial.
Our Comprehensive Measurement Capabilities
Koneksa offers a meticulously tested suite of digital measures and biomarkers. Through our strategic partnerships, we integrate the highest-quality devices and assessments available to support your study protocol and a remote clinical trial. Additional measures may be developed to address on your specific needs.
Our platform and measures are designed to minimize patient and site burden while ensuring high patient compliance. When a patient is non-compliant, compliance alerts are sent to the site and monitors, enabling a rapid response.
Our Industry-Leading Platform and Algorithms
Leading With Science — Always
We take our position as the digital biomarker industry leaders very seriously. Koneksa is not just another technology company, and we are not focused on a single solution. We exist to improve the effectiveness and availability of treatments through a suite of validated, continuously available, objective digital measures via a leading-edge platform and 24/7 support. That’s how we fulfill our commitment to help improve the lives of patients and scientifically founded clinical trials.
If you’re ready to optimize your trial with a science-first solution that delivers the measures that matter for your trial, contact us today.