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Ratings and Reviews 12 Ratings
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What is QureClinical?
As a specialist in Data Management, we provide a wide array of services that encompass not only data management but also the strategic planning and development of statistical analyses along with appropriate CRF design. We take care to ensure that all required documentation adheres to FDA regulations and other pertinent guidelines. Our past experiences have shown that dedicating additional time to the planning phase can significantly improve the efficiency and speed of the trial's concluding stages. Our databases are crafted with precision by experienced data managers who have a deep understanding of various eCRFs and the crucial elements involved in designing electronic data capture systems and collecting data. This level of expertise allows us to develop the eCRF in an impressively short period. Furthermore, the validation and testing of the eCRF are vital components of our design process, performed by specialized personnel to ensure a comprehensive and functional eCRF. By emphasizing these critical aspects, we guarantee exceptional quality outcomes for our clients, fostering a collaborative relationship built on trust and results. Ultimately, our commitment to excellence positions us as a leader in the field of data management services.
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.
Integrations Supported
Integrations Supported
BSI CTMS
ChatGPT
Claude
Cursor
Gemini
Medidata
Oracle Clinical One
Prelude EDC
Tremendous
Veeva Vault
API Availability
API Availability
Has API
Pricing Information
Pricing not provided
Pricing Information
Pricing not provided
Free Trial Offered?
Supported Platforms
SaaS
Supported Platforms
SaaS
Customer Service / Support
Standard Support
Web-Based Support
Customer Service / Support
Standard Support
Web-Based Support
Training Options
Documentation Hub
Online Training
On-Site Training
Training Options
Documentation Hub
Webinars
Online Training
On-Site Training
Company Facts
Organization Name
Quretec
Date Founded
2006
Company Location
Estonia
Company Website
www.quretec.com
Company Facts
Organization Name
Greenlight Guru
Date Founded
2013
Company Location
Denmark
Company Website
www.greenlight.guru/clinical-electronic-data-capture-software
Categories and Features
Clinical Trial Management
Not specified
Electronic Data Capture
Audit Trail
CRF Tracking
Data Entry
Data Verification
Distributed Capture
Document Imaging
Remote Capture
Study Management
Categories and Features
Clinical Trial Management
21 CFR Part 11 Compliance
Electronic Data Capture
Enrollment Management
HIPAA Compliant
Monitoring
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