Ratings and Reviews 12 Ratings
Ratings and Reviews 0 Ratings
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QualioQualio is a unified quality and compliance platform that helps growing life sciences companies scale faster while staying continuously audit- and inspection-ready. Medical device, digital health, biotech, and pharma teams use Qualio to replace manual processes and disconnected tools with a single source of truth for quality, regulatory readiness, and risk. With a modern eQMS at the foundation and Compliance Intelligence layered on top, Qualio moves teams beyond point-in-time audits. Automated gap analysis, cross-standard evidence mapping, and real-time readiness dashboards provide confidence that the organization is prepared today—not just when auditors arrive. Qualio centralizes document control, training, CAPA, change management, supplier quality, and design controls, linking them directly to regulatory requirements and product lifecycle data. Executive-ready views show compliance health by standard, region, and product, turning regulatory readiness into a measurable business capability instead of a black box. Compliance Intelligence continuously monitors for risk, highlights gaps early, and prioritizes remediation so teams focus effort where it matters most. Pre-validated regulatory frameworks are maintained as requirements evolve, reducing reliance on consultants and avoiding duplicate work as companies expand. The result is faster market entry, lower compliance cost, reduced risk of findings or recalls, and confident, risk-managed growth.
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ImorgonSignificantly improve the speed and quality of Radiology reporting by reducing unnecessary dictation, particularly for ultrasound and DEXA. Imorgon transfers modality measurements into Powerscribe/Fluency/RadAI merge fields/tokens, eliminating manual entry errors. Imorgon's specialized services offer the following advantages: - All measurements are always transferred (usually DICOM SR) - Electronic worksheets capture findings and insert them into Powerscribe/Fluency/RadAI (rather than dictating from a worksheet) - Worksheets with priors, calculators, and clinical decision support (TI-RADS, O-RADS, etc) - Integrate into Epic or other EHRs - Vendor neutral - Support to ensure everything continues working Significant improvement in the overhead of reporting with a quick ROI.
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Jama ConnectJama Connect® is an innovative platform for product development that establishes Living Requirements™. It weaves together disparate activities related to testing and risk management, ensuring comprehensive compliance, mitigating potential risks, enhancing processes, and maintaining adherence to regulations. Organizations involved in developing intricate products, systems, and software can now effectively outline, synchronize, and implement their requirements. This streamlined approach significantly decreases the time and resources needed to demonstrate compliance and minimizes the need for rework. By selecting a user-friendly, adaptable solution accompanied by supportive services focused on fostering adoption, companies can confidently pave the way to their success. The platform’s design emphasizes collaboration, ensuring that all stakeholders are aligned throughout the product development lifecycle.
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What is Greenlight Guru Clinical?
Medical device and diagnostics companies running clinical studies are often stuck configuring EDC software that was built for pharmaceutical trials and never designed around FDA, EU MDR, IVDR, or ISO 14155 requirements. Greenlight Guru Clinical solves that by being the only electronic data capture (EDC) system built from the ground up for medtech, so teams aren't reworking someone else's pharma template to fit a device study.
Designed exclusively for medtech, Greenlight Guru Clinical combines an easy to use clinical data platform with industry leading customer service, so teams generate reliable, compliant clinical data with confidence.
Get a single, validated platform covering the full lifecycle of a device or diagnostics study, including:
Electronic Data Collection and eCRF design, with GCP compliant structures and built in audit trails
ePRO/eCOA for patient and clinician reported outcomes, collected in person or remotely on any device
eConsent for compliant, auditable enrollment
Randomization (RTSM) for controlled and comparative studies
PMCF Surveys for post market clinical follow up under EU MDR
Adverse Events Reporting built into the platform
Leading-edge, open API for connecting study data to other clinical or quality systems
Greenlight Guru Clinical supports pre-market clinical investigations, post-market surveillance studies, registries, and human factors testing, and is used by both device and diagnostics manufacturers and by contract research organizations (CROs) that specialize in medtech. A validation package is included with every product update, removing the ongoing burden of software revalidation from the quality team. Every customer also gets a dedicated customer success manager with real medtech experience, not a generalist software account rep. For manufacturers already on Greenlight Guru's quality management system (QMS), Clinical extends into one connected platform spanning quality, product development, and clinical evidence.
What is Digitalis Clinical Data Collection?
Digitalis is an innovative solution for the collection and management of clinical data, operating as an Electronic Data Capture system. This platform offers all the necessary tools for effective and thorough data management, guaranteeing an enjoyable user experience. Its adaptable and user-centric design emphasizes the software’s ease of use and versatility, customized to satisfy unique user needs. As a web-based application, Digitalis eliminates the need for complex installations; access is granted with just a web browser and a reliable internet connection. It is optimized for contemporary web browsers such as Chrome, Firefox, and Safari, while still maintaining functionality on older versions like Internet Explorer 9. Whether used on a desktop or a tablet, Digitalis ensures a consistent user experience, automatically adjusting to fit any screen size. This careful consideration allows for convenient data collection from mobile devices, making it easy to gather information wherever you may be. Overall, Digitalis significantly improves the management and collection of clinical data, establishing itself as an essential resource in contemporary research environments. The platform not only enhances efficiency but also supports researchers in making informed decisions based on accurate data.
Integrations Supported
BSI CTMS
ChatGPT
Claude
Cursor
Gemini
Medidata
Oracle Clinical One
Prelude EDC
Tremendous
Veeva Vault
Integrations Supported
BSI CTMS
ChatGPT
Claude
Cursor
Gemini
Medidata
Oracle Clinical One
Prelude EDC
Tremendous
Veeva Vault
API Availability
Has API
API Availability
Has API
Pricing Information
Pricing not provided
Free Version
Free Trial Offered?
Pricing Information
Pricing not provided
Free Version
Free Trial Offered?
Supported Platforms
SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux
Supported Platforms
SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux
Customer Service / Support
Standard Support
24 Hour Support
Web-Based Support
Customer Service / Support
Standard Support
24 Hour Support
Web-Based Support
Training Options
Documentation Hub
Webinars
Online Training
On-Site Training
Training Options
Documentation Hub
Webinars
Online Training
On-Site Training
Company Facts
Organization Name
Greenlight Guru
Date Founded
2013
Company Location
Denmark
Company Website
www.greenlight.guru/clinical-electronic-data-capture-software
Company Facts
Organization Name
Cerebellis
Date Founded
2016
Company Location
France
Company Website
www.digitalis-cdc.com
Categories and Features
Clinical Trial Management
21 CFR Part 11 Compliance
Document Management
Electronic Data Capture
Enrollment Management
HIPAA Compliant
Monitoring
Patient Database
Recruiting Management
Scheduling
Study Planning
Electronic Data Capture
Audit Trail
CRF Tracking
Data Entry
Data Verification
Distributed Capture
Document Imaging
Document Indexing
Forms Management
Remote Capture
Study Management
Categories and Features
Electronic Data Capture
Audit Trail
CRF Tracking
Data Entry
Data Verification
Distributed Capture
Document Imaging
Document Indexing
Forms Management
Remote Capture
Study Management