secuTrial® | Info & Demo

Quality-assured testing of secuTrial®

New functions are verified by independent testers within the framework of our qualified change management system. The system requirements are checked (quality test) according to a specification (detailed concept, test specification) and any errors or defects are identified at an early stage (maturity management). All positive results produced during testing must be documented with a screenshot and a short description. Any errors must be logged in the bug tracking tool Mantis so they can be subsequently corrected and tested again.

The following test levels are mandatory parts of the tests conducted by the testers:

  1. Integration test on the build server as a preliminary test for early identification of errors and avoidance of unnecessary updates
  2. System test on a staging server
  3. Function test
  4. Data integrity tests
  5. Performance tests
  6. Re-test
  7. Data congruency
  8. Layout/design test/customer friendliness

The framework conditions and end results are documented, signed by the testers and sent to the product manager.

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10th Anniversary: secuTrial® User Group Meeting 2017, Berlin

Topics
– Interfaces and security
– secuTrial® in operation in Nigeria
– secuTrial® and the German MS register

Celebrating a major milestone: 10th anniversary secuTrial® user group meeting with symposium and social evening

This year’s meeting was held in the trendy Berlin district of Friedrichshain at a quirky venue that used to be a sports hall. The weather was fantastic and so was the atmosphere.

10. secuTrial®-Jubiläumsanwendertreffen 10. secuTrial®-Jubiläumsanwendertreffen 10. secuTrial®-Jubiläumsanwendertreffen 10. secuTrial®-Anwendertreffen

A series of highly interesting presentations were enjoyed by the participants. The presentation on “secuTrial® in operation in Nigeria” by Prof. Fortwengel of Hanover was met with a high level of interest – especially by one of our user group members, who just happened to be from Nigeria.

Symposium

Discrepancy Transfer Modul: Solutions for the MS Register
Alexander Stahmann, German MS Society
secuTrial® in operation in Nigeria
Prof. Dr. Gerhard Fortwengel, Hochschule Hannover – University of Applied Sciences and Arts
Implementing add-ons (interfaces, tools) for secuTrial® at the Clinical Trial Centre Leipzig
Andre Rothe, Clinical Trial Centre Leipzig
Safety@Secu
Karolina Weiß, Clinical Trial Centre Leipzig
Requirements and implementation of a deviation workflow in secuTrial®
Dirk Smolinski, CTC UniversityHospital Zurich

Following the numerous requests for individual discussions, this year’s user group meeting was once again held over two days. Participation was confirmed with a certificate.

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Ultra-modern data centre for secuTrial®

Rechenzentrum Vereinzelung

Our hosting service provides a simple and convenient solution for conducting clinical trials and other projects.

secuTrial® and our customers’ data are hosted at one of Europe’s most modern, powerful and energy-efficient data centres: the NBG6 of noris-network AG in Nürnberg.

Rechenzentrum Rechner

The data centre offers:

  • Multiple-redundant systems for secure operation
  • Maximum availability and energy efficiency
  • Maximum security through hermetic perimeter protection and multi-stage fire protection concept with early fire detection
  • Certified to ISO/IEC 27001, ISO/IEC 20000-1, eco Datacenter Star Audit
  • ISO 27001 certificate based on the “IT-Grundschutz” (IT baseline protection) of the BSI (Federal Office for Information Security)

 

Rechenzentrum Aggregat

We monitor the continual quality of the data centre through regular audits.

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9th secuTrial® User Group Meeting 2016, Berlin

Topics
– Interfaces
– secuTrial® as a survey tool
– secuTrial® release 5.0, 5.1 and 5.2, 5.3

Lots of information and news, plenty of familiar faces and the chance to meet new user group members created a fantastic atmosphere, topped off with superb weather. Everyone agreed that this was one of the most enjoyable user group meetings to date at the Pfefferberg in Berlin. It was also one of the most successful, with over 50 participants travelling here to see presentations on current topics and to discuss secuTrial®.

9. secuTrial®–Anwendertreffen | Vortrag 9. secuTrial®–Anwendertreffen | Vortrag
9. secuTrial®–Anwendertreffen | Entwicklungschefin 9. secuTrial®–Anwendertreffen | Willkommen
9. secuTrial®–Anwendertreffen | Mittagspause 9. secuTrial®–Anwendertreffen | Team

As increasingly large data volumes are being transferred from external systems to secuTrial® and from secuTrial® to external systems, this year’s presentation series focused on the different interfaces of secuTrial®:

secuTrial® as a survey tool
Dirk Smolinski, Clinical, Center for Clinical Research, University Hospital Zurich
New import functions and exporting an eCRF to secuTrial®
Andre Genrich, GKM, Munich
Using the automatic report export and import
Gisela Antony, Competence Network on Parkinson’s disease, Universität Marburg
secuTrial® at the Clinical Trial Centre Leipzig
Andre Rothe, Clinical Trial Centre Leipzig

Due to numerous requests for one-to-one discussions, the user group meeting was once again held over the course of two days. Individual participation was confirmed with a certificate.

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EDC systems: what are the advantages of an eCRF?

Electronic data capture (EDC) systems are being increasingly used for data capture in clinical trials. Electronic data capture with eCRFs is progressively replacing paper-based data capture (pCRF).

Using an EDC system has the following advantages:

  • A clear overview of the data is available at all times
  • Inconsistencies can be avoided in advance
  • Incorrect entries are immediately recognised and queried
  • Adverse events are recorded and reported
  • Electronic data capture is secure and can be configured for multiple centres without installing any software
  • Electronic data capture is compliant with 21 CFR Part 11
  • Electronic data capture makes it easier to monitor trials

eCRF_pCRF

Fully electronic or hybrid solution?

In addition to data capture using electronic case report forms (eCRF), secuTrial® offers users the facility to create their own eCRFs without any programming knowledge.

In addition to data capture using electronic case report forms (eCRF), secuTrial® offers users the facility to create their own eCRFs without any programming knowledge.
The query workflow is also conducted completely via the Internet. As the data is checked for completeness and plausibility during the data entry stage, queries can often be avoided. In addition to eliminating errors caused by illegible handwriting, the quickly available reports make it easy to maintain a clear overview of the trial.

As well as providing a purely eCRF-based solution for clinical trails, secuTrial® can also be used as a hybrid solution for trials with centres using a mixture of electronic and paper-based forms. All eCRFs can also be printed out as pCRFs. The data recorded on these paper-based forms can then be entered for the centres using the Double Data Entry function. Queries can also be printed out and sent to the relevant centre.

 

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