Optimizing clinical trials through a powerful digital solution
In the fast-evolving world of clinical trials, it is critical to have streamlined processes
Best-in-class tools are essential for enabling confident go/no-go decisions, empowering teams to navigate the competitive landscape and complexity of clinical trials. At Linus Health, our suite of digital assessments leads the way in transforming clinical trials through innovative solutions that simplify participant recruitment, enhance study outcomes, and help demonstrate clinical meaningfulness.
Our advanced digital platform enhances collaboration across multiple sites, making trials more efficient and effective. With remote, precision digital assessments, trial sponsors can recruit participants and monitor study outcomes, including both safety endpoints and treatment effects.
Digital solutions have revolutionized trial data collection, storage, and analysis. By utilizing electronic data capture, researchers benefit from:
- Centralized, secure data storage, that eliminates manual entry and reduces human error.
- Real-time data access, empowering researchers to monitor trial progress, make informed decisions, and ensure data integrity and security with robust encryption and access controls.
At the heart of the Linus life sciences platform are advanced analytics and evidence-based machine learning algorithms, which optimize participant recruitment strategies and enhance risk identification. These capabilities ensure trials run smoothly and yield meaningful results. Additionally, our platform integrates seamlessly with existing systems, providing a comprehensive solution that supports every aspect of the clinical trial process, from recruitment to outcome analysis.
A digital platform enabling comprehensive approach to brain health
With over 160,000 tests administered globally, our suite of precision digital assessments, featuring integrated electronic Clinical Outcome Assessment (eCOA) solutions, is a trusted tool for optimizing clinical trials.
Our platform offers highly sensitive and accurate assessment batteries that are ready to use off the shelf, enabling streamlined deployment for diverse needs. Our platform can be tailored to suit your protocol needs, leveraging a comprehensive suite of digital assessments, including multiple FDA-listed Class II, CE, and UKCA marked medical devices. These assessments utilize consumer device sensor arrays to simultaneously capture multiple modalities, generating hundreds of precise metrics. When output from our assessments is combined with other biomarkers of choice, performance is further enhanced, delivering robust, accurate insights for clinical trial decision making.
Designed to serve multiple therapeutic areas, our solution supports a wide range of clinical and research applications, including but not limited to:
- Alzheimer’s disease (AD)
- Parkinson’s disease (PD)
- Amyotrophic lateral sclerosis (ALS)
Reducing screen failure rates and participant inconvenience
Pre-screener solution: rDAC
Effective participant recruitment and retention is vital for the success of a clinical trial. Without enough participants, researchers struggle to gather the data needed for accurate conclusions. Traditional recruitment methods are often costly, inefficient, and limited in scope. The Linus life sciences platform streamlines recruitment, helping sponsors meet enrollment targets and improve data quality. As a digital platform, the Linus assessments are not only evidence-based outcome measures but designed around reducing the patient and caregiver burden, supporting study retention. Our remote screening platform permits access to a larger, more diverse participant pool, fostering more representative results and satisfying regulatory guidance – enriching trial outcomes, enhancing timelines, study costs and resources.
The Linus Health pre-screening solution uses a two step approach to enhance recruitment. Our short eligibility assessments reduce screen failure rates and offer accurate phenotyping for study inclusion.
Step one: Remote speech assessments
From the comfort of their home, participants complete a remote speech assessment. The assessment takes approximately eight minutes and can be completed on any smartphone or tablet — no proprietary hardware required.
Step two: In-clinic Digital Clock and Recall (DCR)
Participants with step one results indicating possible impairment are brought into the clinic for a DCR assessment, which typically takes around three minutes. Participants are then classified into one of several cohorts, allowing sponsors or sites to identify the correct participants for a given trial with a high degree of confidence while reducing the screen failure rate.
Measure intervention safety with digital endpoints
Safety endpoint solution
Safety endpoint monitoring is a critical aspect of clinical trials – ensuring patient safety and the efficacy of interventions. Utilizing the Linus life sciences platform streamlines this process, allowing for real-time data availability and more precise monitoring of safety outcomes. This enhances trial accuracy, regulatory compliance, and provides deeper insights into individual patient responses, ultimately improving trial integrity and outcomes.
Powered by sensitive and validated digital assessments, the Linus Health library of digital assessments permits pharma sponsors to adhere to regulatory, safety and ethical obligations.
Bringing the participant’s unique voice into clinical trials
The ePSOMTM tool
The ePSOM tool has been developed to establish meaningful treatment benefits at an individual level, yielding two key outputs:
- Individually defined priorities provided as free-text entries, enabling an in-depth analysis of meaningful treatment benefits across the study sample using natural language processing
- A self-reported ePSOM score in how confident a person feels in their ability to do the things that matter to them the most
The ePSOM tool provides the ability to capture and monitor subtle changes in confidence which the person with disease would notice in themselves which assessments that are not person-centered would fail to capture at an individual-level..
The ePSOM tool can be offered as a single version or a dyad version, incorporating an observer-reported level of assistance required to manage priority outcomes. The tool is designed to be used in older adults with and without cognitive impairment and across different stages of neurodegenerative diseases like AD and related dementias. The ePSOM tool takes approximately ten minutes to complete, uses patient-friendly language, and can be administered remotely or in-clinic.
Revolutionizing brain health globally
Linus partners with you every step of the way
Our platform combines industry-leading AI-enhanced assessments with modern tools for administrators and participants, reducing timelines and costs. Streamlining processes helps boost scalability to accelerate breakthroughs in brain health research. With low-burden, high-precision recruitment and best-in-class digital tools, we help keep your study on time, on budget, and focused on achieving meaningful clinical outcomes for success.
