Reflecting on an Inspiring CZECRIN Annual Conference - News - Institute of Biostatistics and Analyses, Ltd.

Last week, Daniel Schwarz attended the CZECRIN annual conference, which took place in St. Anne's University Hospital Brno. He was very interested in the interactive session dedicated to CTIS, expertly mediated by members of ethics committees from various institutions, as well as the discussion around decentralized clinical trials.

We are proud that our data management solution, CLADE-IS, is fully equipped to overcome these obstacles without resorting to cumbersome solutions.

Key aspects include:

Patient Involvement: In many research projects, we have given patients access to parts of the eCRF. This allows them to report valuable data about their quality of life. Our technical solution has undergone rigorous audits and approvals, including ISO 27k (ISMS) certification, penetration testing and more.
Remote monitoring strategy: Our studies include statistical monitoring and we have actively engaged in research and development of anomaly detection in databases supporting patient registries and RWE / RWD projects.
E-consent: We smoothly solved the problem of e-consent through direct communication between the API of CLADE-IS and the API of the digital signature provider. We were able to implement this using Signi's services, while remaining flexible with other providers as well.
Secondary EHR usage: CLADE-IS boasts an open system with a fully documented API that enables seamless communication with various EHR systems.
We have also established integrations with wearable electronics manufacturers (e.g. auto-injectors) and analytical model providers (e.g. pharmacokinetic modeling).

26. 6. 2023

Back

The Institute of Biostatistics and Analyses is an investigator of the project “Extending services portfolio of an information system for the data management in clinical research”. The project is supported by the OP EIC from the European Union funds.

Main objective of the project is the development of a platform for composition of information systems focused on data management and data mining in the field of pharmaceutical industry and life sciences. Offer of digital services based on a developed and validated information system will make reliable analytical models accessible to the companies for their decision-making and precise information sources for regulatory bodies. The project steps out of a laboratory environment of clinical trials and focuses on the evidence supported by real-world data.