Everything you need to know about onboarding, study building, data management, security, and quality to ensure compliance with ISO 14155:2020, Good Clinical Practice (GCP), and other regulatory requirements.
Our Onboarding includes consultation and recommendations on your clinical data management processes, and you will naturally learn Greenlight Guru Clinical basics and best practices for data management. We also provide templates to use in your internal clinical QMS. Onboarding includes:
Map and visualize your unique data collection plan in Greenlight Guru Clinical
Your project starts with a question in a form:
Your project starts with a question in a form:
The process defines what and when forms shall be completed:
The process defines what and when forms shall be completed:
After creating a process for your clinical data collection, create your site or sites and link them to the relevant Process for the individual site:
After creating a process for your clinical data collection, create your site or sites and link them to the relevant Process for the individual site:
See how you can set up and build a Study in Greenlight Guru Clinical in only 90 seconds.
See how you can set up and build a Study in Greenlight Guru Clinical in only 90 seconds.
Features to ensure GCP and ISO 14155:2020 compliance
Converse on study endpoints with collaborators and communicate via Query Messages.
Full trail of corrections made to the data and a full overview of all Queries.
Converse on study endpoints with collaborators and communicate via Query Messages.
Full trail of corrections made to the data and a full overview of all Queries.
Improve data consistency and validity with Greenlight Guru Clinical's monitoring and verification types. “Verification I & Verification II”. Perform Source Data Verification, remote monitoring and site monitoring.
Improve data consistency and validity with Greenlight Guru Clinical's monitoring and verification types. “Verification I & Verification II”. Perform Source Data Verification, remote monitoring and site monitoring.
Lock data when quality assurance has been performed to secure data for analysis.
Lock data when quality assurance has been performed to secure data for analysis.
Get a quick overview of your Subject population, export data when needed and get a complete overview of site compliance and subject response rates. Supports statistical tools such as SPSS, SAS, STATA, R, Matlab, MS Excel and more.
Get a quick overview of your Subject population, export data when needed and get a complete overview of site compliance and subject response rates. Supports statistical tools such as SPSS, SAS, STATA, R, Matlab, MS Excel and more.
Enable SMS send-oust for quick responses from subjects and increase your response rates.
Enable SMS send-oust for quick responses from subjects and increase your response rates.
Designed and developed in compliance with the PIC/S Guidance, PI-011-3 Good Practices for Computerized Systems in Regulated “GxP” Environments, with software validation based on IEC 62304.
We ensure that you can be compliant with the industry latest standard on GCP for Medical Devices
We ensure that you can be compliant with the industry latest standard on GCP for Medical Devices
We deliver ready-to-use SOP templates you can customize to your own QMS or study protocol. Streamline the documentation process and compliance with our SOP templates and validation templates.
We deliver ready-to-use SOP templates you can customize to your own QMS or study protocol. Streamline the documentation process and compliance with our SOP templates and validation templates.
Greenlight Guru Clinical is designed to protect your data by following industry-leading standards on security, encryption, and access control. The platform comes out-of-the-box with two-step verification, permission-based access control, and extensive system audit logging, all compliant with regulatory requirements.
Greenlight Guru Clinical is designed to protect your data by following industry-leading standards on security, encryption, and access control. The platform comes out-of-the-box with two-step verification, permission-based access control, and extensive system audit logging, all compliant with regulatory requirements.
Greenlight Guru Clinical simplifies regulatory compliance for ISO 14155 (GCP), FDA 21 CFR Part 11, GDPR, and HIPAA by offering ready-to-use QA templates, system modules, and guidance documents.
Read the GCP, FDA Part 11, and HIPAA Compliance Statement
Greenlight Guru Clinical simplifies regulatory compliance for ISO 14155 (GCP), FDA 21 CFR Part 11, GDPR, and HIPAA by offering ready-to-use QA templates, system modules, and guidance documents.
Read the GCP, FDA Part 11, and HIPAA Compliance Statement
Greenlight Guru Clinical experts also offer consultancy, training and custom development services.
Our data management experts can take care of your study setup in Greenlight Guru Clinical, including all forms, questionnaires, validation rules, process design, and ePRO templates for e-mails and SMS.
Our data management experts can take care of your study setup in Greenlight Guru Clinical, including all forms, questionnaires, validation rules, process design, and ePRO templates for e-mails and SMS.
We can deliver both online and on-site training for your sites or end-users. This ensures that all users, investigators, monitors, and other study staff will be comfortable in using Greenlight Guru Clinical thereby increasing compliance and data quality as well.
We can deliver both online and on-site training for your sites or end-users. This ensures that all users, investigators, monitors, and other study staff will be comfortable in using Greenlight Guru Clinical thereby increasing compliance and data quality as well.
With over a decade of experience in medical software development our team can implement custom features or integrations to Greenlight Guru Clinical as needed.
With over a decade of experience in medical software development our team can implement custom features or integrations to Greenlight Guru Clinical as needed.