Greenlight Guru Clinical

Pros: Ease of setup and activation, GG helpdesk readily available in case of questions. Good reporting tools for data extraction.

Cons: Some more in depth/granular tweaking is not possible but this can be accepted taking into account the global ease of use

Overall: I am happy with the user experience and possibilities GG Clinical has to offer. Competitive pricing and a great support experience are also highly appreciated.

Pros: Its an amazing software very easy to learn and adapt, its has a very easy learning curve, its amazing in storing data and very secure and safe as it logs out automatically

Cons: sometimes its hard to navigate when there is too much data it lags a little and exports may not work sometimes

Overall: overall experience is amazing, It is the best data collection app I have used, the security is amazing and the way you can export data and read it its amazing as well

Pros: I like versatility in the types of questionnaires you can have and the support team is very helpful.

Cons: Very laggy and slow. Sometimes features like queries don't work. Participants complain it is not user friendly.

Overall: Not my favorite. Really slow and can make my day frustrating. Participants complain it is not user friendly and it is a major barrier to get them to do questionnaires.

Pros: This was our first human trial experience with our new company. We had some initial study set-up problems that we were able to work through with Ida at Greenlight Guru Clinical. Her help was a lifeline. We like how smoothly things are running now and the overall ease of use of the platform.

Cons: Without control over how long governing authority approvals will take, we would like a pricing option for setting up the study; then the cost of running the study once participants are being entered. We would also like the platform itself to provide data options...appealing looking data displays, charts, that type of thing.

Overall: The one who set up the study for us left the company before we began collecting data. There were some set up items that weren't done correctly and the help we received from Ida and Greenlight Clinical was great. I like the look and relative ease of use of the platform.

Pros: Easy to use and navigate
Good interface
simple
Highlights areas which have not been completed
easy to log back in once it has time out, does not require resending new link codes

Cons: Difficult to find the SAE and AE reporting but once found easy to use

Overall: I really like this product over some of the other platforms i have used in a research capacity, its user friendly.

Pros: Overall, I’ve found Greenlight Guru to be a really useful system
It brings a lot of the documentation and processes into one place, which makes it easier to manage patients throughout the different stages of the trial and keep track of the information being collected.
This is particularly useful when working with a larger number of patients and multiple members of the research team.
I also like the data organisation and structure within the system. It provides a consistent way of entering and managing information, which helps reduce confusion and makes it easier for different members of the trial team to understand the data.

Cons: There are a few things that can be frustrating. The system can take some time to get used to, particularly for new members of the research team who aren't familiar with all of its features.
Finally, navigation could be more straightforward in some areas. When you're trying to find a specific piece of information quickly

Overall: Overall, though, I think Greenlight Guru provides a useful platform for managing patient information during a research trial. The centralised data, patient tracking, audit trail and collaborative features are all strong positives, and once the team becomes familiar with the system, it can make day-to-day data management much more straightforward.

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.

Cons: Features related to how to build questions can be improved. Reminders for PMCF studies as well.

Overall: I have been using GGC for the past 3 years and it's been always a really good experience with the costumer service and the contractor team.

Pros: 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.

Cons: 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.

Overall: 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.

Pros: 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.

Cons: 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.

Overall: Overall, Greenlight Guru Clinical has been a valuable tool for managing clinical studies from a sponsor perspective. The platform supports regulatory compliance, document control, adverse event management, audit readiness, and study oversight throughout the clinical lifecycle. Its centralized approach improves visibility across study activities and enhances communication between stakeholders. The system has helped maintain organized records, support inspection readiness, and increase confidence in data quality and traceability. I would recommend Greenlight Guru Clinical to organizations conducting regulated medical device clinical studies that require reliable study management and compliance-focused processes.

Pros: 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.

Cons: 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.

Overall: Overall, I find the system well suited for study set-up and ongoing study management, with a good balance between functionality and flexibility.

After using GGC for several years, I can say that I am very happy with the cooperation and would recommend GGC to other companies and study teams looking for a reliable and flexible EDC solution.

Pros: 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: 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.

Overall: Although it is not the most comprehensive data capture I have used, it is a solid entry level option for organizations that need to implement a study but do not have dedicated EDC programming personnel. Can be limited at times but gets the job done while supporting changes during study conduct without causing major issues to data exports for minor changes.

Pros: It is easy to navigate and use. Everything is clearly labelled. Always support from the data team. Queries are clearly labelled and simple to answer.

Cons: Having to double answer why you are changing an answer. Can be time consuming.

Overall: Very happy with overall experience. Would recommend the use of Greenlight Guru to other studies as their database.