Our Modules
With our modular system structure, you can adapt the functionality exactly to the requirements of your study. You only pay for what you need.
Basic Software
Our software offers a comprehensive solution for data collection in clinical studies with a flexible eCRF designer that is available on any device without installation.
Intuitive participant management with secure pseudonymization and helpful filters for easy tracking of individual processing status.
Integrated validation and monitoring tools that ensure data integrity throughout the entire course of the study.
Unlimited scalability – supports any number of users, patients, and visits.
One-click data export into a universal CSV format.
Full regulatory compliance with GCP, FDA 21 CFR Part 11, HIPAA, and GDPR.
Secure data storage in an ISO 27001-certified data centers in Germany.
Multicenter Module
If several partners at different locations are involved in the study, this module allows all locations to actively participate. Study centers can be equipped with individual access rights so that, for example, each center can only view and edit its own patients. Each patient can be pseudonymously assigned to a study center. This makes it easy to determine, for example, the recruitment rate of each center.
Unlimited number of study centers
Unlimited number of users (study team)
Unlimited number of participants
Unlimited visits
Unlimited number of eCRFs and questions
Unlimited data points
Individual assignment of rights for each center, groups, or individual persons
Query Management
Our Query Management module supports you in managing, processing, and documenting all queries: Conveniently create new queries directly where they occur. Keep an overview of the number and status of queries. Communicate with the study center directly within the Query Management system. Naturally, all processes are fully stored in the Audit Trail.
Complete administration and processing of queries in the software
Automatic documentation of every question and answer incl. processor (Audit Trail)
Unlimited queries
Individual access and editing rights
Survey / ePRO
The Survey/ePRO module allows for the creation of surveys/questionnaires that can be filled out by the patients themselves. Sending is done via a link or a QR code. Both can be sent to the participant either by email or letter. Each subject has exclusive access to their own questionnaire. Processing can be interrupted at any time and resumed at the same point later. Caching happens automatically, so entries can never be lost.
Layperson-friendly and intuitive user guidance
Sending of the questionnaire via individual link or QR code
Usable on all devices (smartphone, tablet, PC...)
Automatic caching of all entered data
All questions can be displayed in different font sizes
All entered data available in real-time
Biosample Management
In some studies, blood, serum, or other biosamples are collected, analyzed, and evaluated. The Biosample Module supports you with the complete workflow related to the samples. The entire process is supported, from the creation of labels to the shipping of the sample, through to life-cycle management and documentation of results.
Support in creating sample ID labels
Support with sample shipping
Documentation of the sample lifecycle from collection to measurement
Visit Scheduler
Especially with tight deadlines for follow-up visits, a forgotten appointment can quickly lead to a drop-out. The Visit Scheduler makes it easier to coordinate all appointments and reminds study partcipantsv of upcoming visits by e-mail.
Overview of weekly appointments for the study team
E-mail reminder for participants of upcoming visits
Randomization
Participants can be automatically assigned to groups according to individual specifications. You can define the randomisation specifications, the number of groups and the weighting. You can specify which members of the study team are allowed to randomise and who is allowed to unblind.
Simple randomization
Block randomization
Stratified randomization
Identity Management
Store personal identifying data in compliance with data protection regulations: separate storage, databases and server.
Access by name
Using emails and phone numbers
Role based access permissions
Compliant with GDPR and other regulations
API Access
For the connection to external systems.
