A regulatory-compliant clinical trial management system

Product
overview

In the dynamic landscape of medical research, the utilization of a robust Clinical Trial Management System (CTMS) emerges as indispensable. Streamlining intricate processes, enhancing collaboration, and ensuring compliance, a CTMS not only mitigates the challenges inherent in traditional trial management but also optimizes efficiency, data quality and data accuracy.

ParTrial, our regulatory-complaint Clinical Trial Management System is designed to become your Single Source of Truth. Streamline and optimize the complex processes associated with clinical trials by automating manual tasks, improving efficiency, ensuring compliance, and providing comprehensive insights.  

 It also serves as a centralized hub that enables collaboration between study team, researchers, trial coordinators, and other stakeholders to efficiently plan, execute, and monitor clinical trials from start to finish, enhancing the overall productivity, transparency, accuracy and success of clinical trials, benefiting not only sponsors and CROs, but also researchers and patients. 

ParTrial is more than a standalone software product – it’s a complete integrated solution to manage all stages of a trial lifecycle.

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Key benefits

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By automating manual tasks such as document management, linked folders to upload files in all sites/studies, version control and eTMF maintenance, tracking patient recruitment progress, facilitating communication between stakeholders with notifications related to sample and drug logistics, inventory tracking, etc.

Electronic communication and document management systems streamline interactions between stakeholders optimizing resource allocation and saving time.

Assists with maintaining regulatory compliance by providing tools to manage and track required documentation and version controlling, to ensure that all necessary documentation for audits is complete, up-to-date and easily accessible. Gain confidence in front of audits with complete and traceable data to ensure data quality and integrity.

Within a centralized platform where all stakeholders can access, interact, comment, review and approve documentation, raising the overall quality of the clinical trial.

Easily integrate ParTrial with other clinical systems such as eCRFs using the API to streamline data exchange, enhance data consistency and reduce manual data entry, ensuring that patient values and status are continuously updated, and the study’s progress is reflected while improving overall trial quality and data integrity.

Modules for sample and drug management guarantee stock and deliveries and provide visibility over available samples for subsequent studies.

Key features

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    • Site feasibility: creates feasibility forms and manages the protocol synopsis distribution to principal investigators and study coordinators across multiple sites. It oversees site participation and patients’ confirmations within the trial general dashboard.

 

    • Site management: capabilities for managing multiple trial sites, facilitating effective communication and collaboration among different sites and their principal investigators, streamlining operations and enhancing productivity from planning to the final report.

 

    • Regulatory: assists with regulatory activity planning across multiple countries including required documentation checklist to be submitted to competent authorities, communication management encompassing actions, clarifications and amendments, integration with eTMF for secure archiving of submitted documentation, and tracking of planned versus actual dates throughout the trial’s regulatory process.

 

    • Roles and permissions management: securing access to critical data by controlling access levels for different users and custom role types to ensure a flexible approach to fit any organization.

 

    • Participants’ management: it provides tools to plan, track and manage participant recruitment and enrollment, ensuring accurate participant data collection, improving efficiency, and reducing errors.

 

    • Monitoring: it offers integrated monitoring for site visits and streamlines reporting through online report creation, review and validation. It enables stakeholders to monitor trial progress and site performance, track issues and protocol deviations and access up-to-date information on the overall study status. This facilitates proactive decision-making and enhances risk management.

The eTMF and eISF are secure and easily accessible digital solutions designed to manage critical documentation and records associated with a clinical trial, both at sponsor and investigator site level, offering enhanced efficiency, organization, reducing manual effort, minimizing errors, and strengthening collaboration and compliance throughout the trial process:

    • Centralized Repository: for all trial related documentation that allows its management, organization and version controlling.

 

    • Document Collaboration & Workflows: enables seamless collaboration among trial stakeholders by allowing multiple users to access, review and contribute to trial documents simultaneously.

 

    • Regulatory Compliance: designed to meet regulatory standards and requirements. It assists in maintaining compliance by providing audit trails, version control and document tracking capabilities.

 

    • Integrated Monitoring and Oversight: it offers monitoring and oversight features, allowing sponsors, clinical research associates (CRAs), and regulatory authorities to track and review trial documentation, ensuring completeness, accuracy, and timeliness. This facilitates efficient monitoring during site visits and regulatory inspections.

 

    • Document Quality and Control: eTMF provides functionalities to ensure document quality and control. It offers features such as document indexing, metadata capture, and quality checks, ensuring that documents are organized, searchable, and meet predefined quality standards.

 

    • Customization and Configurability: eISF adapts to the specific needs of the investigator site and trial. Users can configure the system to match their workflow and create custom document templates.

It is a centralized and automated solution that helps streamline and optimize the management of investigational drugs and study supplies throughout the clinical trial lifecycle, ensuring efficient supply chain management and compliance with regulatory requirements. It also improves patient safety by maintaining accurate records and facilitating detailed information of drug usage, contributing to cost savings, future investigation, and smoother operations.

This feature empowers customers to visualize cross-study data from all trials, as well as analyzing specific trial data effectively, enabling data-driven decision-making, performance evaluation, and strategic planning for overall trial success.

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 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.

All changes in data and configurations are tracked. The system provides information about timestamps and user performing a given action allowing the possibility of tracing back all sequence of events leading to a specific action.  

Responsive design, clear navigation, and specific interfaces for each trial to accommodate different user roles. It also provides features such as e-mail or feasibility form composition to enhance user experience.

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).

It supports integration with eCRFs via API and data retrieval to other third-party applications (i.e. dashboarding).

Support & training

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We provide a documentation portal including all educational resources and training materials to help users get the most of ParTrial. Both standard and tailor-made training and certifications are also available for all user types.

A customer specific support portal provides 24/7 technical support with a dedicated key account manager. Create support tickets to ensure that all issues are properly logged and tracked facilitating efficient follow-up and resolution.

We perform regular and scheduled software updates including new features and functionalities and security improvements to stay up-to-date and adhered to industry standards, compliance, and regulatory requirements.

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.

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.