Comprehensive and innovative.
secuTrial® is a fully developed solution for the web-based collection and management of patient data. It is continuously developed in cooperation with users and offers a comprehensive range of functions as well as all the usual advantages of specially designed study software.
Key features of secuTrial®
- Simple and independent study setup
- Completely web-based application
- User-friendly operation and intuitive user interface
- Dynamic forms
- Annotated eCRFs
- Integrated test environment
- Standardised import and export interfaces
- Integrated image management
- Patient Reported Outcome
- Full compliance with regulatory standards
- Extensive randomization options
- Labelling of missing values
- Patient files printed in PDF format
- Data entry via app
The modular concept enables you to combine typical question components such as radio buttons or number and text fields as required. Appropriate elements can then be selected from a series of predefined plausibility checks. The visit plan can be easily modified to suit your study setup. No prior knowledge of programming is required.
As secuTrial® is completely browser based, no software needs to be installed for administration or data collection. In addition to defining the study setup, managing participants and exporting data from any PC with Internet access, you can even enter patient data.
secuTrial® was developed in cooperation with users, focussing on a user-friendly design right from the outset. The application is logically structured and intuitively designed. To ensure ease of use, the study forms have a similar structure to the paper forms.
To prevent data entry errors and increase data quality, the user interface and the structure of the eCRF in an EDC system should be as simple and clearly structured as possible.
secuTrial® offers you the facility to display only those entry fields which are actually needed in the eCRFs . Entry fields which are dependent on preceding user entries are only displayed once these entries have been made.
In the FormBuilder you can immediately view all designed forms in a preview window. You can also view all table and column names, including all defined rules. In addition, there is the option to save the entire study setup as a dossier.
The AdminTool, DataCapture and ExportSearchTool are located in a separate test area (setup) and in a productive area. You can test all functions before beginning your study or when implementing changes in productive mode prior to releasing them for users. After successful testing, one click is all that is required to set up the study to productive mode. The changes are always included in the new project version.
You can import data from CSV-formatted tables for an entire study and multiple patients into secuTrial®. External and internal keys can be mapped in advance in the FormBuilder. It is also possible to import data via a web service into secuTrial. Supported export formats are SAS, SPSS and CSV. Data can be exported with secuTrial® in the CDISC standard ODM 1.3.
From secuTrial® Version 3.0 there is the facility to manage images in DICOM format or standard formats such as jpg, png, tif, avi and mpg. Along with the usual form content, these images can be uploaded and pseudonymised. Modifications to images can be tracked in the AuditTrail and all original images can be exported again.
Patient Reported Outcome is offered as an optional study feature. In addition to the data documented by clinical investigators, this option allows study-relevant data to be collected from the patients themselves. The clinical investigator can create the patients in the system and assign a user name and password. The patients can then view their file and input their own measurement data (e.g. blood sugar levels) or make entries assessing their quality of life.
When validating study data, it is important to know if a value has been intentionally or accidentally left out.
In secuTrial® the “missing values” function has been created for this purpose. It allows the user to indicate that a value has not been entered during data collection and to give a reason for the omission.
As it is platform-independent, the PDF file format is particularly suitable for the long-term archiving of documents. Regardless of the original application programme, operating system or hardware platform, PDF files can always be displayed exactly in their original form.
In secuTrial® the entire eCRF of a patient can be printed in both HTML and PDF format.
For international studies, it is not only the eCRFs but also the entire user interface together with all texts and reports that need to be displayed in the language of each country, e.g. when patients are required to enter their own data.
Working in close cooperation with our customers, we have translated the user interface of secuTrial® into multiple languages. In addition to German, English and French, secuTrial® now offers Spanish, Italian and Polish as language options.
The convenient smartphone app that we have developed is a simple way for patients to enter study-relevant data.
The app offers numerous attractive functions for the user. The data entry times, for example, can be adjusted to the study plan by temporarily freezing the forms. A reminder system helps to ensure regular entries. To accommodate different situations, data can even be entered when no Internet access is available. The next time that an Internet connection is possible, an authentication process will be initiated and the encrypted data will then be securely transmitted to secuTrial®.
secuTrial® fulfils all regulatory standards (CRF, GCP) and offers all FDA-compliant functions such as an audit trail, roles and rights concept and electronic signatures. Furthermore, secuTrial® has been subjected to multiple independent benchmark audits. Full compliance has been certified with 21 CFR Part 11 and the associated regulations.
Randomization is commonly used in evidence-based clinical studies, in particular in order to statistically minimise individual influences on the outcome of the study.
secuTrial® offers seven algorithms for randomization.
- Extended stratified block without list (secuTrial)
- Range minimization
- Variance minimization
- Static unstratified single block randomization
- Static unstratified multi block randomization
- Static stratified block randomization
- Simple randomization
These algorithms work with multiple randomization groups (= treatment arms).
The randomization can be unblinded, single-blind, double-blind or triple-blind. During randomization various stratification factors can be taken into account based on patient characteristics, either within a centre or a project.
It is also possible to carry out the randomization using external software. The created lists can then be uploaded into secuTrial®.