Trium Analysis Online GmbH is an internationally operating company, providing web-based solutions and services for healthcare and life sciences. Trium's primary company objective is "Improving Human Health" by online collection, analysis and dissemination clinical and biomedical data.
Our core competency is at the interface between mathematics, informatics and medicine. We apply our know-how to develop highly functional and efficient tools. Having the user in mind, we do our best to design user-centered and customizable software. Around the globe, we cooperate with other technology leaders and work closely with scientific institutes and universities to ensure continuous quality. With a certified and comprehensive QM system in accordance with ISO 13485, we fulfill the expectations in our industry.
Trium Analysis Online was founded in September 1999 as a spin-off from the Institute of Medical Statistics and Epidemiology (IMSE) at the Technical University of Munich/Klinikum rechts der Isar. Up to the time of foundation the managing directors Dr. rer. nat. Martin Daumer and Dipl.-Stat. Michael Scholz had gained more than ten years experience in telemedicine and in clinical trials.
"Trium CTG Online" is a class IIb medical device used for fetal and maternal monitoring (Cardio-Toko-Graphy) in clinical practice, including telemedicine, based on on-line algorithms to analyze and classify fetal heart rate patterns. Trium CTG Online is "device agnostic" and can be combined with all major CTG monitoring devices. Mobile users such as physicians and midwives can use web-browsers on any suitable stationary or mobile device to perform remote monitoring and care of patients at any location and at any time. The remote monitoring solution is Trium CTG mobile fleet, which is a medical system containing Trium CTG Online and suitable and selected fetal heart rate monitoring devices.
"actibelt" is a technology platform - comprising devices, algorithms and software - for the use of wearable sensors in clinical trials and research. A continuous stream of wearable sensor data is stored on the actibelt "recording box" that can be worn in a belt buckle. These data are collected, transferred and analyzed by validated software packages to form a new class of activity related digital biomarkers such as real world walking speed.
Trium has discontinued to offer its eTrials platform “Clinical Trial Engine” to external customers. "CT-Engine" is a web-based electronic data capture system for supporting data management in clinical trials.
"Improving Human Health" underpins the corporate philosophy and the "vision" of Trium. It is therefore, a declared goal to deliver services that we promise our customers – and thus ultimately the patient – in the defined form as specified by regulations. Only in this way is it possible to ensure the highest degree of safety for the users or beneficiaries of our products and services. We ensure continuous growth and the development of new markets through cooperation with other technology leaders and close collaboration with scientific institutes and universities. We develop highly functional and effective solutions for telemedicine and clinical studies under the guiding aspect of achieving a plus in quality of life for our customers. All employees are expected to work according to the basic principles of the Quality Management System. At the same time, they are encouraged to contribute to the maintenance of the Quality Management System.
Trium's mission can be summarized as ("the big opportunity", according to John Kotter): "By combining expertise, methods, tools, devices, data, customers and networks in our core areas our team can become the best tool-box maker for
- the use of accelerometers in clinical trials
- FHR monitoring in clinical practice, including telemedicine
Trium has established the concept of "CMCEvolve" ("Continuous Monitoring for Continuous Evolution") - inspired by https://www.boeing.com/company/about-bca/aviation-safety.page#/monitor) - to avoid errors before they unfold and to manage a crisis.
The following guidelines comprise the essence of this concept:
- truth and transparency; Should be valid equally internal and external. We have a close collaboration with the School of Computation, Information and Technology, TUM Technische Universität München and the Human Motion Institute (https://link.springer.com/book/10.1007/978-3-662-28998-3), regularly published peer review papers in relation to our technology and participate and conduct international symposium relevant to our technology
- diversity, agility and respect
- principle of parsimony: "as little as possible, as much as necessary" (Occam's razor https://en.wikipedia.org/wiki/Occam%27s_razor)
- avoid "pseudoaccuracy", i.e. making decisions based solely on quantitative observations (or metrics) and ignoring all others (https://en.wikipedia.org/wiki/McNamara_fallacy)
- improved decision making - subjective team decisions in the light of (semi-) quantitative assessment of categories - thereby avoiding cognitive basis, which is a common source for human errors that arise heuristics and biases (https://en.wikipedia.org/wiki/Daniel_Kahneman)
- "Altocumulus Lenticularis principle": apart from weekly team meetings, we conduct discussion meetings with an extended group of high level, robust participants/experts during the process of critical/important decision making (https://en.wikipedia.org/wiki/Lenticular_cloud)
- warning: the core quality suffers from a focus on "formal" QM activities (The Audit Society: Rituals of Verification https://www.bmj.com/content/316/7133/787.2)
It is, therefore, our obligation to maintain Trium's reputation and success by setting appropriate and realistic goals and working towards continuous quality improvement. The latter is ensured by observing regulatory requirements, involving customers and employees, conducting internal audits and management assessments.
All employees are aware that they are an integral part of a constant "learning organization", which at the same time must continuously change itself in order to remain sustainable. High quality work and motivation, as well as continuous further training, are encouraged, in order to strengthen the sense of shared responsibility among employees for the company as a whole.
As a tool for focused communication we follow the basic principles of "SBAR" (https://en.wikipedia.org/wiki/SBAR):
Significantly shorter development cycles are also common practice in medical technology today. Customer-oriented, beneficial innovations are, therefore, essential for survival in the long run. As a company, we, therefore, avoid squandering resource and allowing ineffectiveness in favour of the realistic assessment of new projects and product ideas in terms of feasibility, benefits and business success.
With the entry into force of the QM System, Management and all employees of Trium Analysis Online GmbH have committed themselves to carry out their activities carefully according to the descriptions of the QM System, in order to ensure the fulfilment of customer requirements and the set quality goals.
- Successful completion of MDR transition
- Development of strategic partnership with GE and initiations in the field of actibelt
- Maintenance of business operations in the light of MDR regulatory chaos
- Extraction of opportunities from Corona
- Participation in projects consistent with Improving Human Health
- Donation to selected charitable institutions in the field of "Improving Human Health
- Completion of the last remaining CT-Engine projects
- Further establishment of the basic principles/guidelines with regard to CMCEvolve
- Planning for the rental situation from 2023 onwards
- Continued open error and improvement culture with customers and partners
- Striving for excellence
- Application of the further education and training concept and determination of the real need through appraisal interviews
- Supervision of diploma, bachelor and master students, doctoral theses and industrial internships
- Contribution to relevant professional symposia
- Publications mentioning our products/brand names
- Quality optimization & further development of products & services
- CTG Online
- Upgrade of technology stack (reduction of technical debts)
- Introduction of new features
- Mobile Fleet
- Bringing the platform "mobile fleet" for pregnancy home monitoring to the
- Starting clinical study using “mobile fleet”
- Introduction of “mobile fleet” App.
- Successful closing of the ZIM & Novartis projects
- Integration of actibelt in new grant proposals and commercial studies
- Maintenance of SGS certification (Consumer Recording Box)
- Expanding collaboration toward regulatory acceptance