secuTrial®-User Group MeetingOur annual User Group Meetings: lectures, discussions, networking - and always in fine weather.
Regulations, validations & auditsGCP, 21 CRF Part11 + many other standards! secuTrial® is designed for licensing approval of pharmaceuticals.
Key Data secuTrial®Customer installations: > 50 Projects: > 660 Number of centres: > 3.000 Number of participants: > 14.500 Number of patients: > 250.000
Dr. Ulrike Jonas
Product Manager secuTrial®
Tel. 0049 30 225050 499
– 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®.
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.
Work experience placement with secuTrial®: Prototype video guide developed by school pupil with our help
As part of his work experience placement, Aaron Paape developed a fantastic prototype for a series of step-by-step video guides on how to get started with secuTrial®.
Covering tasks such as “Login”, “Create new patient” and “Print pseudonym”, the short videos explain each process step by step. These basic data entry guides will be available to all users for training purposes in future.
Aaron is a pupil of the Alexander Puschkin School in Berlin Lichtenberg and already had experience with screen capture software. With our support, he optimised the recordings and video editing, added music and voiceovers and created German subtitles.
We were impressed with the focus and dedication he showed during his work placement and are delighted with the extremely useful results he produced.
The research unit “Clinical research in emerging countries” of the Hannover University of Applied Sciences and Arts led by Prof. Dr. Gerhard Fortwengel is conducting a study on HIV in Enugu in cooperation with the University of Nigeria. In the study, the influence of therapy on bone density is being investigated and compared in around 800 HIV positive and HIV negative patients.
We are providing the entire infrastructure and the necessary licenses for secuTrial® free of charge for the study setup and the browser-based data entry system.
We would like to thank Professor Fortwengel for this wonderful opportunity to help.
– Validation of studies
– Practical example of use with tablet computers
– secuTrial® release 4.8 and 4.9
The countless discussions and excellent atmosphere of previous years continued at this 8th user group meeting. The outstanding participation of our clients from the pharmaceutical, academic and medical technology industries helps us to develop a future-proof product that is geared towards the needs of practice.
Due the numerous requests for individual discussions, the user group meeting was held over two days.
Participation in our symposium was confirmed with a certificate. The following presentations were held:
GAMP 5 – Supplier evaluation: How can secuTrial® help?
Dr. Ulrike Jonas, secuTrial®
Standards for the validation of studies and updates
Dirk Smolinski, CTC ZKF Universitätsspital und Universität Zürich
Birgitt Wiese, Biometrie Medizinische Hochschule Hannover
Dr. Corinna Engel, Center for Pediatric Clinical Studies (CPCS)
Linda Gusky, CIOffice Forschungsnetze, Universitätsmedizin Göttingen
Patient self-documentation within the framework of a study with secuTrial and tablet computers
Lorenzo Hess, Appletree Biostatistics AG/Appletree CI Group AG, Winterthur
New requirements and requests were then subsequently discussed. After reaching a general consensus, the future functions of secuTrial® were agreed.
We were one of three manufacturers who once again participated in the EDC challenge of the the German association for Health Information Managers (DVMD). After a brief presentation of the company and the system, the challenge was to solve various practice-oriented tasks within a set time.
In front of a large audience, we presented standard data entry processes, different layout options, data checks across visits and many other functions directly in secuTrial®. We were able to fulfil all of the requirements and demonstrated how quickly and user-friendly it is to work with secuTrial®.
The response was very positive and many interested individuals came to see us at to our standard at the industry exhibition afterwards.