Greenlight Guru Clinical

Greenlight Guru Clinical

Greenlight Guru
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About

Your clinical trial technology partner …together we create better trials We provide state of the art software solutions but we believe in the human touch. We’ll work with you to make your next trial the best one yet. Study set-up in a matter of days. We will set-up for you, or you can build your own. Investigator or subject led data collection on any device. All the features you need in an intuitive and integrated application. Meet your regulatory and business objectives. A trained, experienced human being will respond to your query and prioritize its resolution. Currently helping medical device companies meet their business and compliance requirements.

About

Greenlight Guru Clinical is the only electronic data capture (EDC) system built specifically for medical device and diagnostics companies, not adapted from pharma. Designed exclusively for medtech, it combines an easy to use clinical data platform with industry leading customer service, helping teams generate reliable, compliant clinical data under FDA, EU MDR, IVDR, and ISO 14155 requirements. Get a single, validated platform for medical device studies, including: Electronic Data Collection and eCRF ePRO/eCOA (electronic patient and clinician reported outcomes) eConsent Randomization (RTSM) PMCF Surveys (post market clinical follow up) Adverse Events Reporting Open API Used by device manufacturers and medtech CROs running clinical investigations, PMCF studies, registries, and human factors testing. Every customer gets a dedicated customer success manager with real medtech experience and a validation package included with every product update.

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Audience

Medical device, pharmaceutical, food

Audience

Medical Device Manufacturers

Support

Phone Support
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

Screenshots and Videos

Screenshots and Videos

Pricing

No information available.
Free Version
Free Trial

Pricing

No information available.
Free Version
Free Trial

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

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Reviews/Ratings

Overall 4.3 / 5
ease 4.3 / 5
features 3.7 / 5
design 4.3 / 5
support 4.5 / 5

Pros & Cons from Real Users

Pros

  • GGC is user friendly and very simple to build. I like how support can always provide information and insights on how to improve or build your eCRF in the best way.
  • One feature I do appreciate is the ability for sites to upload source documentation directly into the system. This can be very helpful for remote monitoring. However, the source-document workflow also has significant limitations. When a site needs to amend previously uploaded source documentation and uploads the revised version, the previously uploaded version is no longer readily visible to the CRA. Unless the CRA happened to download and retain the earlier version separately, it can be difficult to compare the original documentation with the amended version. From a monitoring and traceability perspective, it would be extremely beneficial to have clearly accessible version history for uploaded source documents so that prior and amended versions can be reviewed side by side. The audit trail is another area that I find difficult to navigate. Information that should be readily available to support monitoring and data review can take considerable effort to locate. An EDC audit trail should make it relatively straightforward to understand what changed, when it changed, and who made the change. Finally, reporting is one of the most frustrating aspects of the system. Reports can generate very large Excel spreadsheets containing far more information than is needed for routine monitoring purposes. Considerable time can then be spent manipulating and filtering the spreadsheet simply to obtain a small amount of useful information. More flexible reporting options would greatly improve the CRA experience. For example, it would be extremely helpful to generate a simple PDF report showing subjects and the visits/eCRFs that have been entered, completed, monitored, or remain outstanding without having to extract that information from a large spreadsheet. Overall, Greenlight Guru has functionality that can support clinical research, particularly the ability to upload source documentation for remote review. However, from a CRA monitoring perspective, the platform would benefit significantly from improvements in navigation, concomitant medication management, individual-row SDV functionality, source-document version history, audit-trail accessibility, and customizable reporting. A more intuitive monitoring interface with less duplication and easier access to essential information would substantially reduce the administrative burden on CRAs and allow more monitoring time to be focused on data quality, protocol compliance, and subject safety.
  • Greenlight Guru Clinical provides an efficient and well-structured platform for managing clinical studies in a regulated medical device environment. The system offers strong traceability between study activities, adverse event reporting, monitoring activities, and study documentation. Data entry workflows are intuitive, user permissions are configurable, and electronic records are maintained in a manner that supports compliance with GCP and applicable regulatory requirements. The ability to centralize study documentation, track participant data, and maintain audit trails has improved oversight and study execution. The platform also facilitates collaboration between sponsors, investigators, monitors, and quality personnel while maintaining data integrity and controlled access.
  • I have been using GGC at my company since 2019 and I have been very satisfied with the system. It is reliable, user-friendly and offers good flexibility for different study requirements. Setting up new studies is straightforward and efficient, allowing studies to be set up within a short time. One of the main advantages for me is the support provided by GGC. They are easy to reach and usually respond within a few hours if there is a problem or if I have a question. The communication is always friendly, helpful and solution-oriented. I also appreciate that GGC is open to customer requests and feedback. If a customer needs a function that is not currently available, GGC is willing to discuss possible solutions and, where possible, further develop the system to meet specific requirements. This makes GGC a very flexible and customer-oriented partner.
  • Can be easily programmed by someone without experience coding or with software. Simple to implement rules and validations. Intuitive to use for sites and study staff. Non-blocking amendments is a great addition in the last year.

Cons

  • Features related to how to build questions can be improved. Reminders for PMCF studies as well.
  • From a CRA perspective, my overall experience with Greenlight Guru as an electronic data capture (EDC) system has been challenging and, unfortunately, not very positive. Having worked as a CRA for more than 20 years and across numerous EDC platforms, I find several aspects of the system unnecessarily complicated and inefficient for clinical monitoring. One of my biggest concerns is the management and review of concomitant medications. I have not encountered another EDC where concomitant medications are presented for monitoring in this manner. Medication information appears in two separate areas of the system. Within the Screening eCRFs, the concomitant medication section can only be SDV'd as a whole rather than allowing the CRA to SDV individual medication entries. There is then a separate medication area accessed through the prescription bottle icon, where individual medications can be reviewed and monitored separately. This creates a confusing and duplicative workflow. The CRA ultimately needs to access the separate medication area to adequately review individual entries, yet SDV activity is also required within the Screening eCRF section. Additionally, I have encountered instances where medication details do not appear to transfer consistently between the two areas, resulting in information that does not match. From a monitoring and data-quality perspective, concomitant medications should ideally have one clearly defined location where individual medication records can be reviewed, queried, and SDV'd. Visit identification and navigation are also difficult. There are multiple tabs that appear nearly identical, making it unnecessarily challenging to quickly distinguish one visit or section from another. For CRAs who routinely move between subjects, visits, forms, queries, and source documents, clear visit identifiers and intuitive navigation are extremely important. The current design can significantly increase the amount of time required to perform routine monitoring activities.
  • While the platform is highly capable, some workflows require multiple navigation steps to locate specific records or reports. Advanced reporting and data export capabilities could benefit from additional customization options to support organization-specific metrics and trending. Initial configuration and user onboarding may require training to ensure users fully leverage all available functionality. Occasional interface improvements could further streamline commonly used study management activities.
  • If I had to mention one area for improvement, some very complex data validation rules or advanced form development requirements can be challenging to implement. For example, certain dynamic functions, such as using a patient's response from one question in the text of another question, are not possible to set up (yet?). However, these are rather specific requirements, and GGC is usually open to discussing possible solutions.
  • Can be a bit restrictive, for example cannot use calculated values in a validation rule which makes it more difficult to implement controls for inclusion and exclusion criteria. Export labels can be difficult to work with. Skipped or missing visits can cause issues. SDV is difficult to verify only part of a visit.

Training

Documentation
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

CRFweb
Founded: 2012
United Kingdom
www.crfweb.com

Company Information

Greenlight Guru
Founded: 2013
Denmark
www.greenlight.guru/clinical-electronic-data-capture-software

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Categories

Categories

Electronic Data Capture Features

Audit Trail
CRF Tracking
Data Entry
Data Verification
Distributed Capture
Document Imaging
Document Indexing
Forms Management
Remote Capture
Study Management

Electronic Data Capture Features

Audit Trail
CRF Tracking
Data Entry
Data Verification
Distributed Capture
Document Imaging
Document Indexing
Forms Management
Remote Capture
Study Management

Clinical Trial Management Features

21 CFR Part 11 Compliance
Document Management
Electronic Data Capture
Enrollment Management
HIPAA Compliant
Monitoring
Patient Database
Recruiting Management
Scheduling
Study Planning

Integrations

BSI CTMS
ChatGPT
Claude
Cursor
Gemini
Medidata
Oracle Clinical One
Prelude EDC
Tremendous
Veeva Vault

Integrations

BSI CTMS
ChatGPT
Claude
Cursor
Gemini
Medidata
Oracle Clinical One
Prelude EDC
Tremendous
Veeva Vault
Claim CRFweb and update features and information
Claim CRFweb and update features and information
Claim Greenlight Guru Clinical and update features and information
Claim Greenlight Guru Clinical and update features and information