Bridging the knowledge gap between patient insights and study design

Product
overview

In the conventional landscape of clinical trials, gathering data from enrolled patients follows a dated paradigm reliant on periodic check-ins and scheduled visits, inevitably causing significant delays in obtaining critical insights. Additionally, establishing effective communication channels with patients proves to be a challenge. Patients may face difficulties in reporting symptoms or providing feedback, and there is often a lack of standardized methods for consistently collecting this vital information.

Encouraging active patient engagement in clinical trials presents its own set of hurdles, influenced by factors such as patient motivation or the perceived value of their input.

Bridging the gap between patients and researchers is a complex task that leads to a fragmented understanding of the patient experience. Real-time access to patient information emerges as a key enhancement, providing the means to unlock invaluable insights promptly and facilitate informed decisions and adjustments throughout the entirety of a trial.

InTrialCare is the patient-centric app that addresses these challenges, transforming the way we connect with and understand patients within the context of patient engagement in clinical trials.

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Key benefits

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InTrialCare elevates your clinical trial, providing real-time insights, enhancing patient engagement, and paving the way to trial success.

Elevate patient engagement in clinical trials with an app carefully designed to seamlessly deliver crucial information between treatment cycles, ensuring optimal involvement.

Harness the potential of our AI-powered algorithm to predict potential dropouts, analyze the psychometric and physiologic state of participants, and guide them back to a more stable stage through personalized content suggestions provided by AI.

Enhance physicians’ and sponsors’ understanding of patients’ psychometric state, symptoms, and side effects in intricate detail and real-time.

Safeguard patient-collected data in the cloud, ensuring traceability in accordance with GDPR and GCP regulations.

Gather direct patient feedback on your study for prompt protocol corrections, maximizing drug efficiency and achieving an optimal study design.

Key features

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InTrialCare forges a direct link between patients and healthcare professionals. Its intuitive interface allows immediate reporting of symptoms and side effects with a high level of detail and psychometric states from the comfort of patients’ homes. InTrialCare, powered by AI technology, tailors personalized content to enhance the patient experience throughout the entire trial journey.

Utilize objective, dynamic graphs illustrating the impact and severity of side effects for each patient. This enables doctors to conduct optimal follow-ups, maximizing the efficiency of medical visits.

Harness the capability to deploy AI models for predicting patient persistence and drop-out rates within the clinical trial. Early insights empower proactive decisions, potentially leading to an extended patient recruitment process or even a reopening of the trial.

Anticipate and address potential imbalances in randomized cohorts between the test and control arms, especially considering patient dropouts. This approach not only bolsters the scientific validity of the study but also upholds the robustness of statistical analyses.

Technical details

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Virtual private cloud-based hosting to ensure data isolation, and segmentation. This allows customers to have their data in the most appropriate geographical region.

Robust and scalable database management system to efficiently handle large volumes of trial data. It supports data storage, retrieval, and querying capabilities to enable efficient data management and analysis.

Strong security measures are in place to ensure the confidentiality and integrity of patient information. This includes encryption of data transmission, user authentication, access controls, and adherence to data privacy regulations such as HIPAA or GDPR.

The system meticulously tracks all changes in data and configurations, offering detailed information on timestamps and the user responsible for a specific action. This feature enables the thorough tracing of the entire sequence of events leading to a particular action.

InTrialCare boasts a responsive design, intuitive navigation, and specialized interfaces catering to each user type. The sponsor benefits from a dedicated desktop version, facilitating real-time access to aggregated patient information, trial progress KPIs, and the execution of predictive models. Physicians, utilizing a desktop version, gain detailed insights into patient-reported symptoms and adverse events, optimizing their medical visits. Patients, on the other hand, enjoy a user-friendly mobile app that enables them to report their psychometric and physiological status, access pertinent study information, and directly communicate with the medical team.

Designed to handle the increasing volume of data and user load as the organization’s trial portfolio grows. Resources are automatically scaled based on usage to accommodate multiple trials, patients, and users while maintaining optimal performance.

The InTrialCare app is compatible with major operating systems, including iOS and Android, offering flexibility in device selection for patients. The patient monitoring dashboard is a SaaS (software as a service) solution compatible with macOS, Windows and chromium-based web browsers (Edge and Chrome), facilitating easy access for healthcare professionals using desktop or laptop devices.

Support & training

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There is a set up process to personalize all the app contents according to the clinical trial, support during the presentation of all the documents to the ethical committee, and training on dashboards for sponsors. We also offer training to make the most of the data extracted from the app.

For ongoing support, a customer-specific portal ensures 24/7 access to technical assistance, guided by a dedicated key account manager. Our support system encourages the creation of support tickets to log and track issues systematically, streamlining efficient follow-up and resolution.

To stay current and in compliance with industry standards and regulatory requirements, we regularly conduct scheduled software updates. These updates encompass new features, enhanced functionalities, and security improvements, ensuring our system remains up-to-date and aligned with the latest industry benchmarks.

Security & compliance

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Science4Tech is an ISO 27001 certified company.

All our software is designed, built, tested, and maintained according to GAMP5 guidelines and security development practices. It complies to industry standards and regulatory requirements, such as Good Clinical Practice (GCP) guidelines, FDA regulations for electronic records and signatures (21 CFR Part 11), Health Insurance Portability and Accountability Act (HIPAA) and EU data protection (GDPR).

For desktop features, each customer has a virtual private cloud (VPC) in a specific geographic region to comply with regional requirements, with network security controls including firewalls, encryption, and strict security policies to ensure compliance and prevent unauthorized access.

It supports features that facilitate compliance, such as audit trails for all data entries, access controls and data validation checks.

Each new release is notified to the customer and vulnerability assessments are performed to address potential vulnerabilities proactively. Our in-house compliance team supports audits and provides guidelines about how to validate software to be used in compliant environments.