Medicai's clinical trial PACS integrates with your EDC and trial systems to organize imaging data across all sites, with a full 21 CFR Part 11-compliant audit trail, automated de-identification and re-identification, and granular access control. Retrieve, view, store, and share studies across sites without installing or downloading locally.
Medicai provides a cloud-based PACS and DICOM viewer solution that seamlessly integrates with any CTMS, ensuring centralized and real-time access to imaging data. With automated data capture, advanced analytics, and AI-driven insights, Medicai significantly enhances data consistency, accelerates clinical trial workflows, and improves patient management.
Our platform guarantees strict regulatory compliance, maintaining detailed audit trails and secure data storage for HIPAA, GDPR, and 21 CFR Part 11. Through streamlined collaboration tools, annotation features, and customizable dashboards, research teams can make informed decisions quickly.
By reducing manual processes and optimizing resources, Medicai’s imaging services for clinical trials drives efficiency, shortens trial timelines, and supports faster drug development.
Clinical trial imaging carries requirements that general PACS does not. Medicai is built for them: a 21 CFR Part 11-aligned audit trail on every image interaction; automated de-identification and re-identification so sponsors and pharma teams work only with anonymized data while sites retain the link; support for blinded independent central review (BICR) workflows, where reads are separated from site staff; and HIPAA-ready, GDPR-aligned handling backed by ISO 27001 and ISO 9001 certifications. Studies, pathology, reports, and related documents stay in one compliant, multi-site archive from first scan to database lock.
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Some of the key features of our imaging solution for CTMSs are:
Since Medicai is entirely cloud-based, no software needs to be downloaded or installed for viewing any study or research. This guarantees convenience and adaptability for users taking part in clinical trial management.
Our platform complies with strict privacy laws and regulations regarding clinical software solutions, ensuring the security of the system and the privacy of sensitive medical imaging data.
Integrated checks and audit logging features help users adhere to regulatory requirements throughout the clinical trial process.
Role-based access control ensures that only authorized personnel access specific medical imaging data, enhancing security and privacy.
Medicai provides safe, long-term DICOM storage, guaranteeing data availability and integrity during clinical studies.
We have protocols for anonymizing patient information. Pharma companies are not allowed to interact with the protected health information of patients. Other providers might also face restrictions on their ability to interact with PHIs. Therefore, Medicai's de-identification engine enables them to establish automated workflows.
Medicai’s Clinical Trials PACS software transforms trial management with seamless imaging integration, real-time data access, and advanced analytics. Enhance compliance, streamline workflows, and accelerate timelines while reducing costs.
Medicai’s cloud-based platform ensures instant, secure access to medical images, enabling researchers and clinicians to collaborate from any location. Real-time synchronization means updated data is always available, drastically reducing lag times. This on-demand accessibility accelerates trial workflows, allowing for faster decision-making and ultimately boosting the overall quality of research outcomes.
By seamlessly integrating PACS with your CTMS, Medicai eliminates manual data entry errors and ensures consistent imaging data across all trial sites. Automated processes, combined with secure data capture methods, maintain high-quality data integrity. This level of precision leads to more reliable outcomes and offers dependable support for regulatory submissions.
Medicai is designed to meet stringent standards, including HIPAA, GDPR, and 21 CFR Part 11, ensuring compliance throughout your clinical trial’s imaging workflow. Our system automatically logs audit trails for every image interaction, maintaining transparency and accountability. This robust compliance framework significantly mitigates risk and accelerates the approval process for treatments.
Medicai supports annotation, sharing, and messaging features directly within the PACS environment, uniting geographically dispersed research teams. This collaborative approach allows for rapid feedback on imaging findings, eliminating communication gaps. By fostering real-time dialogue, Medicai helps your team make quicker, evidence-based decisions that keep trials on schedule and under budget.
By integrating imaging data management within your existing CTMS, Medicai reduces duplication of tasks and lowers operational overhead. Automated processes and robust analytics help identify inefficiencies and streamline resource allocation. This efficient approach ultimately cuts costs, conserves staff time, and delivers faster results without compromising quality or patient safety.
Medicai integrates with AI and machine learning algorithms to automate image analysis, revealing critical patterns and predicting outcomes sooner. These intelligent tools highlight anomalies, quantify disease progression, and even suggest optimal treatment pathways. This level of insight empowers faster, evidence-based decisions, expediting trial timelines and enhancing overall research reliability.
Medicai's platform provides an intuitive user interface for uploading, storing, and exchanging medical images for clinical trials. There is no need for complex software installations because users can safely access the platform from any device with an internet connection. Throughout the clinical trial process, role-based access control and built-in compliance checks guarantee that sensitive data is compliant and safe.
Due to its interoperability, Medicai can be integrated with any other clinical trial platform or clinical trial automation software. Also, we can connect multiple clinical research sites, making them work as one.
Our multi-enterprise solution enables a new approach to clinical trials. Connect and retreive imaging studies for patients enrolled in the clinical trials directly from the participating centers.
Medicai's interoperable imaging infrastructure provides a robust foundation for multi-location clinical trials. The infrastructure can store studies, together with other medical documents and files (including pathology studies), in a secure and compliant way.
Our imaging orchestration layer enables automatic connections with AI companies and manages the processes of de-identification and re-identification.
Access control is granular and easy to define and manage.
Clinical trial data can be accessed and visualized through our web portal and mobile apps. Both frontends embed the DICOM Viewer.
The Medicai accounts are multi-organization, so if a doctor or a researcher participates in multiple clinical trials, they can view the data from the same user account.
Collaboration is easy with Medicai's functionality: audio/video calling, messaging, notifications, and document signing.
Pharma companies have access to aggregated, anonymized (de-identified) data and can easily manage the progress in real time.
Imaging and DICOM capabilities can be embedded in already-existing clinical trial management software using our APIs.
Give it a try, play with it! Using our embeddable DICOM Viewer, you can easily view your DICOM files anywhere online (web, in the mobile application). Your DICOM files are stored in your Medicai workspace, in your cloud PACS.
"With Medicai, we can access patient medical data like CT scans and other medical documents. We organize our multidisciplinary discussions of diffuse interstitial lung diseases online, using the Medicai platform. These discussions aim to establish a definite diagnosis and bring consensus on the therapeutic recommendations."
MD. PhD. Claudia Toma
Choose Medicai as your trusted clinical trials imaging company and experience unrivaled data accessibility, streamlined workflows, and robust compliance. As a top-tier imaging vendor for clinical trials, we excel in the dynamic diagnostic imaging clinical trials market, offering real-time collaboration, AI-driven insights, and transparent audit trails. Empower your research with faster, better-informed decisions—partner with Medicai today for results.
Does it support blinded independent central review (BICR)?
Yes. Medicai supports blinded independent central review workflows, separating image reads from site staff and controlling who can see which studies through granular role-based access. This lets sponsors run consistent, bias-controlled central reads across all trial sites from one platform.
How is patient data de-identified for sponsors and reviewers?
Medicai automates de-identification so sponsors, pharma teams, and central reviewers work only with anonymized imaging, while the site retains the link needed for re-identification. This keeps protected health information at the site and lets the study team analyze imaging without exposure to patient identifiers.
What is a clinical trial PACS?
A clinical trial PACS is a picture archiving and communication system built for the requirements of clinical research rather than routine care. It centralizes imaging across trial sites, maintains a 21 CFR Part 11-aligned audit trail, automates de-identification, and supports the blinded review and multi-site access that sponsors and CROs need. Medicai provides a cloud-based clinical trial PACS with no local installation required.
How do you choose a clinical trial PACS?
When choosing a clinical trial PACS, evaluate four things beyond standard imaging features: whether it maintains a 21 CFR Part 11-aligned audit trail, whether it automates de-identification and re-identification, whether it supports blinded independent central review, and whether it centralizes imaging across all sites in one archive through to database lock. These research-specific controls, not the viewer alone, separate a trial-ready platform from a general PACS.
How does a clinical trial PACS support regulatory compliance?
A clinical trial PACS supports compliance through a 21 CFR Part 11-aligned audit trail on every image interaction, automated de-identification that keeps patient identifiers at the site, role-based access control, and secure long-term storage. Medicai is also HIPAA-ready, GDPR-aligned, and ISO 27001 and ISO 9001 certified, so imaging data meets research data-protection standards across regions.
How does imaging integrate across trial sites and EDC systems?
Medicai centralizes imaging from every participating site in one cloud archive and connects to your EDC and trial systems through standards-based interfaces, so imaging endpoints flow into the study record without manual transfers or per-site installations. Authorized team members retrieve, view, and share studies from any location.
Seamlessly retrieve, view, store, and share medical imaging data with a robust multi-location, cloud PACS storage, zero-footprint DICOM viewers, AI support, and best-in-class sharing capabilities.
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Investigations
Medical ImagingPET CT ScanMRI ScanCT ScanMammogramsAngiographyMR AngiographyUltrasoundDEXA Scans
