Higher quality EHR data extraction for faster insights

Product
overview

Conducting a clinical trial involves managing vast and sensitive patient data. Challenges like large data volumes, poor system interoperability, and data quality concerns underscore the need for advanced EHR data extraction technologies. Successfully navigating these complexities demands a commitment to ethical and regulatory standards, coupled with rigorous processes.

CapTrial is a cutting-edge software solution designed to revolutionize the way clinical data is managed. By leveraging the power of artificial intelligence and advanced data processing, CapTrial seamlessly extracts, organizes, and contextualizes data from electronic health records (EHRs), facilitating effortless retrieval of information, gaining valuable insights, and automating the generation of up-to-date electronic Case Report Forms (eCRFs) synchronized with EHR updates.

CapTrial initiates at the data source, processing the connected EHR data extraction including patient anonymization. The data and metadata are securely encrypted and transmitted to the cloud, ensuring complete traceability and compliance. In the cloud, the data is processed and structured to automatically generate the eCRFs, reducing errors and alleviating the burdensome manual tasks associated with data entry and form generation. This enables researchers, medical professionals, and sponsors to concentrate on what truly matters: advancing healthcare innovation.

Our innovative platform not only automates the EHR data extraction process but also rigorously adheres to the stringent provider requirements outlined in Good Clinical Practice (GCP).

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Key benefits

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Streamline data collection and integration processes to significantly reduce the time required for the initiation and completion of clinical trials. Real-time updates and AI-driven efficiencies play a pivotal role in expediting decision-making processes.

Mitigate data entry errors with AI-driven validation checks, safeguarding the integrity and accuracy of collected data. This enhancement directly contributes to the improved reliability of trial results.

Rapid retrieval of comprehensive and standardized patient data from EHRs facilitates improved safety monitoring and early detection of potential issues, prioritizing the well-being of trial participants.

Trim operational costs linked to manual data entry, verification, and reconciliation. Our solution optimizes processes, leading to substantial savings for both sponsors and sites. 

Utilize AI algorithms to continuously analyze incoming data, identify patterns, and potential insights in real-time, enabling adaptive protocols. Respond promptly to emerging data trends while upholding the scientific rigor required by regulatory authorities.

Safeguard against compliance risks by aligning with GCP standards and meeting other regulatory requirements. The platform’s transparent audit trail creates a comprehensive record to support regulatory submissions effectively.

Embrace a patient-centric approach by leveraging AI to identify eligible participants more efficiently, seamlessly integrating CapTrial with our MatchTrial. 

From single-center studies to complex multi-center trials, our adaptable solution accommodates diverse trial requirements, providing flexibility for sponsors engaged in various research endeavors.

Key features

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Harnessing advanced AI algorithms, CapTrial seamlessly harmonizes diverse data sets from EHRs, ensuring standardized, accurate information ready for comprehensive clinical trial analysis.

CapTrial facilitates real-time data transfer and updates, ensuring researchers have immediate access to the most pertinent patient information. This enhances the efficiency and agility of clinical trials.

Personalize data mapping to fit the unique requirements of each clinical trial. CapTrial facilitates seamless integration with diverse EHR systems, accommodating a variety of data formats and structures.

CapTrial integrates robust validation checks to minimize errors and omissions, ensuring the delivery of high-quality, reliable data for analysis. 

Demonstrating a commitment to data security and privacy, CapTrial adheres to the most stringent regulations, including HIPAA. We guarantee the safeguarding of sensitive patient information throughout the entire data transfer and capture process.

CapTrial upholds transparency and accountability through a meticulous audit trail. Every data entry and modification are logged, creating a comprehensive record for regulatory compliance and quality assurance purposes.

CapTrial is engineered to accommodate the rising volume and complexity of clinical trial data. It seamlessly scales to meet the demands of both small-scale studies and large multi-center trials, adapting to your evolving research requirements.

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 and multiple trials. It supports data storage, retrieval, and querying capabilities to enable efficient data management and analysis. 

Strong security measures are in place to protect sensitive trial data. 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.   

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, sites, and users while maintaining optimal performance. 

SaaS (software as a service) solution which provides hassle free set up process. Updates and patches are automatically deployed. It is compatible with macOS, Windows and chromium based web browsers (Edge and Chrome). 

Seamless integration is supported through project implementation with the hospital’s available Electronic Health Records (EHR) system. 

Security & compliance

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Science4Tech is a ISO 27001 certified company. 

All our software is designed, build 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).  

Each customer has a virtual private cloud (VPC) in a specific geografic region to comply with regional requirements, with network security controls including firewalls, encription and strict security policies to ensure compliance and prevent unauthorised access.  

It supports features that facilitate compliance, such as audit trails, access controls and data validation checks. Traceability to the raw data is kept all the time and all the data structured by AI models contains an explanation of the interpretation and includes the reference in the raw data.

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. 

Support & training

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We initiate implementations with a comprehensive project aimed at connecting all new sites and establishing the primary database. Our training program encompasses the use of all tools, and customized implementations come with specific training and user manuals tailored to individual needs.

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. 

Pricing & licensing

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CapTrial necessitates an initial installation, encompassing site connectivity, data extraction, and model validation. Subscription-based access is provided for data storage, ensuring compliance, maintenance, and access to dashboards. The quotation for custom implementation is contingent upon various factors, including the number of distinct sites and countries (languages) for each clinical trial. To obtain a personalized quotation, kindly reach out to our sales team.