Reliable and compliant eCRF for clinical studies
Granitics eCRF is a reliable and validated system for clinical research data management. Its design takes into account the requirements that authorities in the EU and the US place on data management systems.
Standards and regulations taken into account
The system supports compliance with the requirements of the ICH GCP E6(R3) guideline, the FDA 21 CFR Part 11 regulation and the ISO 14155:2020 standard. These requirements have been taken into account in the system's design, development and validation.
Strict requirements for subcontractors
We extend our requirements to our subcontractors as well, because the entire chain has to work properly. For example, we require ISO 27001 certification from the service provider responsible for maintaining the system. We also require subcontractors to have documented and compliant procedures, particularly with regard to information security.
Secure access and use
The system includes two-factor authentication and continuous monitoring of use. The study is responsible for ensuring that the right people have appropriate rights and access only to the information relevant to them. This is made easier by the information the system provides on user roles and rights.
Information security and data location
Study data includes health information, so information security is a key requirement in how the service is delivered and maintained. The main principles are summarised below, and a more detailed description is provided to customers in an information security statement.
Data stays in Finland
The service and its data are located in Finland, in a data centre whose information security management system is ISO/IEC 27001 certified. Data is not transferred outside the EU or EEA unless required by law or by an order of an authority.
Daily backups
Data is backed up once a day with versioning, and backups are retained for at least six months. Restoring from a backup is tested at least twice a year.
Protected access and encrypted traffic
Access to the study team's system is restricted to networks specified by the customer, and logging in always requires two-factor authentication. All user interface traffic is encrypted.
Data protection agreed by contract
The customer is the controller of the study data, and Granitics Ltd acts as the processor of personal data. The processing is agreed in a data processing agreement in accordance with the GDPR.
Explore the features of Granitics eCRF
Explore our other features too. Together they cover your study's data collection from planning to analysis.
Self-Enrolment
Granitics eCRF lets participants enrol in a study on a self-service basis. The same feature can also be used to collect data from a target group through surveys.
Audit Trail
All actions related to study data are comprehensively recorded in the Audit Trail log. Recorded actions include data entries, changes, views and deletions.
Online surveys
Surveys are a good way to gather views or experiences on a study topic. Granitics eCRF offers an easy way to run a survey for either a broad audience, such as event attendees, or a defined group. People can take part anonymously, for example at a trade fair via a QR code, or personal links can be sent to a selected group.
Data retrieval and export
The right format for every purpose – study data can be exported in several commonly used formats. The data is ready for analysis, reporting and archiving without extra conversions.
Electronic signature
Granitics eCRF enables study data to be approved with an electronic signature. The feature supports a transparent study process and helps ensure that the data collected can be reliably approved for analysis and reporting.
Monitoring
Granitics eCRF provides comprehensive tools for monitoring clinical studies. Monitoring is a key part of study quality assurance, as it ensures that study data is correct, complete and compliant with the protocol. Granitics eCRF enables efficient monitoring and clear collaboration between the study team and monitors.
Messaging
Granitics eCRF enables secure and traceable communication between the study team and participants. Centralised messaging makes study coordination easier, reduces the risk of errors and ensures that all messages are documented as part of the study process.
ePRO questionnaires
ePRO (electronic Patient-Reported Outcomes) lets participants enter data directly into the study system. They do this by answering questionnaires in a browser-based interface, with no separate apps to install.
Automatic notifications and alerts
Email and text message alerts can be set up for study team members. This way, important events are not missed even when the system is not open.
Double blinding
Granitics eCRF supports double blinding, one of the key methods for ensuring the reliability of clinical study results. In a double-blind study, neither the participant nor the investigator conducting the study knows which group the participant belongs to.
Randomisation
Granitics eCRF includes a built-in randomisation function that supports reliable and transparent clinical studies. Randomisation can be carried out directly in the system without separate tools, which reduces the risk of errors and keeps the study process under control.
Multicentre studies
Granitics eCRF is designed to support multicentre studies in which several organisations, research units or hospitals take part in the same study. The study can be managed centrally while each centre works securely and clearly within its own role.
Clear user interface
The user interface is designed to be clear and intuitive. Study staff learn to use it quickly, leaving more time for the research itself.
Role-based access rights
Granitics eCRF user accounts are personal, and logging in requires two-factor authentication. The study can add new users itself and assign them study-specific roles and access rights. Users can have different roles and permissions in different studies.
Free online demo
May we show you Granitics eCRF?
In an online demo, we present the features and functions of the eCRF and discuss how it could improve your research. The demo is free of charge and without obligation.
Granitics Ltd