IBA, Ltd., secondary image

Institute of Biostatistics and Analyses, Ltd.

Spin-off company of the Masaryk University

The Institute of Biostatistics and Analyses of the Masaryk University as an academic entity has been devoted to clinical research project since the early 2000s. With the increasing significance of contract research activities, however, the pressure to provide more professional services was growing. For this reason, Institute of Biostatistics and Analyses Ltd (IBA) was established in 2014 as a spin-off company of the Masaryk University with a share of ownership by the parent institution, taking over activities unrelated to academic grants and education.

Although the history of IBA activities on the market is not very long, the company has an extensive network of supplier and client contacts. These relations were established during a more than 15-year period of contract research activities carried out by the above-mentioned academic entity.

IBA activities are directed at the sector of pharmaceutical industry and life sciences; in this regard, IBA develops and runs information systems for the collection, validation and analysis of clinical data, using both local (desktop) and online (web-based) technologies. These systems, often called electronic data capture (EDC) systems, serve for the collection, management and analysis of data in clinical/health research projects. IBA provides complete services in these projects, including trial or registry design, CRF/eCRF proposal, document completion and communication with regulatory bodies, ensuring expert guarantee by medical societies, data reporting and study monitoring. These services are complemented by a comprehensive support in other areas such as (i) market access, (ii) cost-effectiveness analyses, (iii) pharmacovigilance, (iv) analysis of clinical data including advanced biostatistics, (v) development of tailored software products with a special emphasis on databases and online services, (vi) graphic design.

Structure

Struktura společnosti

Quality and management

Certline logo

Institute of Biostatistics and Analyses Ltd (IBA Ltd) has implemented the integrated system of quality management in accordance with ISO/IEC 20000-1:2006 (guaranteeing the quality of IT services), EN ISO 9001:2009 (quality management systems), and ISO/IEC 27001:2006 (information security management system). Our outputs and services are currently guaranteed by the ISO/IEC 27001 certificate. The quality management system as well as the IT service management system remain implemented, and have been maintained according to the latest versions of the respective standards. The Division of Clinical Projects team also focuses on the management of clinical research projects, and has undergone training in the good clinical practice (GCP).

The point of the above-mentioned standard is to map and to monitor all processes taking place in the organisation, which subsequently facilitates their effective management and control. On top of that, introduction of these standards significantly reduces potential risks occurring from providing IT services and processing data, in terms of technical failure, personnel issues, or even natural disasters.

The three certifications have logical links and mutually complement each other: EN ISO 9001:2009 is a well-known standard of more general characteristics ensuring effective management of the organisation and high quality of products or services. In contrast, ISO/IEC 20000-1:2006 is a relatively new standard focusing on the quality of IT services, their reliability, availability and support for clients in case of problems. Both standards are supplemented with ISO/IEC 27001:2006, which refers to information security management.

Institute of Biostatistics and Analyses, Ltd.