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.
Several randomisation methods
Participants can be randomised into two or more study groups, up to a maximum of ten. The system supports three methods: simple randomisation, weighted randomisation with allocation ratios defined for each group (unequal simple randomisation), and block randomisation with either a fixed or a random block length. A participant can also be assigned to a group manually, for example if randomisation is carried out outside the system.
Stratification keeps groups balanced
Block randomisation can use one or more stratification variables, in which case the system generates a separate permutation sequence for each stratum. This keeps the composition of the study groups balanced with respect to age, sex or other variables relevant to the study.
Every randomisation step is traceable
All randomisation actions are automatically recorded in the Audit Trail log. The log captures details such as the time, the user and the randomisation result, which ensures full traceability and supports regulatory compliance (e.g. 21 CFR Part 11). A randomisation result cannot be changed afterwards, and the results can be downloaded as a PDF report.
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.
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.
Reliable and compliant
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.
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