TrialKit PACS

TrialKit PACS, developed by Crucial Data Solutions, is a clinical trial imaging solution that enables researchers to access, interact with, and adjudicate medical images from the same platform used to manage all other study data. By integrating DICOM and non-DICOM imaging directly into the TrialKit ecosystem, it eliminates data silos and provides a centralized hub for both clinical and imaging data — making it suitable for oncology, neurology, imaging-based endpoint research, and a broad range of other therapeutic areas and study types.

A Picture Archiving and Communication System (PACS) is a medical imaging technology used to securely store, retrieve, manage, and share digital images such as X-rays, MRIs, CT scans, and ultrasounds. In the context of clinical trials, TrialKit PACS serves as a centralized solution for organizing imaging data, reducing manual handling, standardizing imaging protocols, maintaining data integrity, and ensuring regulatory compliance — while supporting real-time collaboration and remote monitoring across decentralized or multi-site studies.

Supported Imaging Modalities

• X-rays for assessing bone structure, fractures, and orthopedic conditions
• Magnetic Resonance Imaging (MRI) for high-resolution views of soft tissue, brain activity, and tumors
• Computed Tomography (CT) scans for cross-sectional imaging and volumetric analysis
• Ultrasounds for real-time imaging in prenatal, cardiovascular, and organ studies
• PET scans for metabolic activity monitoring in oncology and neurology research
• DICOM and non-DICOM formats to ensure compatibility with virtually any imaging device or vendor system

Key Features and Capabilities

• Real-time access and evaluation of DICOM imaging: Researchers can instantly access and evaluate medical images, enabling faster, informed decisions that protect patient safety and data quality.
• Robust image interaction: TrialKit's DICOM viewer includes tools for in-depth image analysis, allowing researchers to calibrate, zoom, pan, and adjust image view settings for detailed examination of clinical trial imaging.
• Anonymization, annotation, and collaboration: Images can be quickly anonymized to prevent sharing of sensitive data. Users can annotate images and collaborate with other viewers in real-time, sharing insights, confirming findings, and identifying discrepancies.
• Integration with data analytics: Imaging data is integrated into TrialKit's analytic capabilities, allowing researchers to correlate imaging findings with other trial metrics within a single platform for deeper and faster study insights.
• Customizable dashboard reporting: Researchers can configure and generate customizable dashboard reports that include imaging data alongside other clinical trial metrics, providing a comprehensive overview of trial progress and outcomes for stakeholder reporting.
• Secure and compliant cloud storage: The platform adheres to global regulatory requirements, ensuring that the storage and handling of medical images meet stringent security protocols and data integrity standards.
• Audit trails for enhanced accountability: Every interaction with images within TrialKit is meticulously logged, enhancing accountability and transparency — critical for regulatory compliance and data integrity.

Unified Imaging and Clinical Data Management

• TrialKit PACS is fully integrated into the broader TrialKit ecosystem, giving sponsors and CROs a single login to access both imaging endpoints and other study data.
• Imaging files can be mapped directly to subjects, visits, and case report forms (eCRFs), making it straightforward to associate scans with specific timepoints or clinical outcomes.
• The integration eliminates the complexity of working across multiple disconnected systems and accelerates image review timelines.
• Intuitive access to imaging data is available on both desktop and mobile devices, supporting studies of any scale — from single-site to global multi-center trials.

Regulatory Compliance and Security

• TrialKit PACS is fully compliant with HIPAA, FDA 21 CFR Part 11, and GDPR.
• The platform includes encrypted data storage, controlled user access, and comprehensive audit trails to ensure compliance and data security.

TrialKit PACS is designed for sponsors, CROs, and research sites seeking to streamline imaging workflows within a unified clinical trial management environment. Its cloud-based architecture, broad modality support, and deep integration with TrialKit's eCRF and analytics tools make it a comprehensive solution for managing imaging data across the full lifecycle of a clinical trial.