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

Company structure

Quality management

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.

Our key people

Petr Brabec

Petr Brabec, PhD

Petr is the chief executive officer (CEO) and one of the company’s founders. He is primarily engaged in searching for new opportunities and in the development of international cooperation. He has been involved in clinical research projects since the early 2000s. During his career, he has participated in hundreds of research projects (both grant-aided and commercial ones) in the areas of oncology, haematology, neurology and rare diseases. He is the author or co-author of numerous research papers. In his own words, articles published in The Lancet Oncology and the Journal of Clinical Oncology were among his biggest scientific achievements.

Assoc. Prof. Daniel Schwarz, PhD

One of the company’s founders, Daniel is the chief information officer (CIO), mainly overseeing the agile software development. He is an associate professor at the Masaryk University and at the Brno University of Technology, and his research interests are focused on neuroscience, processing and analysis of image data, machine learning and artificial intelligence. As of October 2017, he was the author or co-author of 35 papers in peer-reviewed journals, two monographs and five chapters in books; he participated in the development of 12 engineering works, including one applied certified methodology.

Daniel Schwarz
Karla Henčlová

Karla Henčlová, MSc

Karla is the chief operating officer (COO) and has been working in the company since 2017. Her responsibilities involve a smooth running of the company, setting up internal processes and financial control. She has 17 years of experience as COO and CEO in the top management of Czech and multinational companies.

Ilona Lundová, MSc

Ilona has been working in our company since mid-2015 and as the Head of the Finance Department she is responsible for financial management. She is involved in accountancy and tax issues and in overseeing company’s economy status. She has gained experience as an accountant, financial manager, and particularly as an economic expert in a multinational company.

Ilona Lundová
Michaela Škrabalová

Michaela Škrabalová, MSc

Michaela is the quality manager and has been working with us since 2016. Since 2014 she has been dealing with good practice and quality assurance in pharmacy (GMP/GCP/GPP). She is responsible for the quality management system in compliance with effective versions of the international standards EN ISO 9001, ISO/IEC 27 001 and ISO/IEC 20 000-1, and in compliance with the GPP/GCP requirements. Her responsibilities also involve implementation of the General Data Protection Regulation.

Marika Chrápavá, MSc

Marika is the Head of Department of Clinical Projects and has been working in the company since 2015. She has been dealing with project management in the pharmaceutical industry and with related issues such as quality management and regulatory affairs since 2003. In her career, she has led dozens of research projects (both grant-aided and commercial ones) focusing on medical devices and medicinal products: from basic research, preclinical and clinical development to placing a product on the market. Her knowledge and experience in time and finance management, as well as keeping documentation in accordance with the quality management system and legislative requirements, are invaluable assets for project management.

Marika Chrápavá
Jaroslav Koča

Jaroslav Koča, MSc

Jaroslav is the Head of Department of Data Management and has been part of the company since the very beginning. He has been working in clinical research since 2006; most of the time, he has been dealing with activities related to management of clinical data from both commercial and academic projects. He keeps a good track of the complex management of clinical data on the project level (such as CRF design, database development, data processing, programming of validations, data revision, quality control etc.) and is also experienced in the development of standard procedures as well as in the selection of a suitable electronic system for the collection and processing of clinical data.

Petra Ovesná, PhD

Petra is the Head of Department of Data Analysis and has been part of the company since the very beginning. She has been dealing with analyses of clinical data since 2009 and is the author or co-author of numerous research papers. During her career in clinical and experimental research, she has participated in many projects where she was responsible for the study design, selection of appropriate statistical methods, processing of analyses, writing reports and publications. In the academic sector, she participates in grant projects and supervises graduate students.

Petra Ovesná
Petr Leixner

Petr Leixner, MSc

Petr leads the team of Clade-IS developers. He has been involved in the development of this system since the very beginning. He has been actively engaged in the development of web applications since his school years. He has gained a lot of experience over the years, from the development of simple websites to setting up e-shops and, finally, complex information systems. In the Institute of Biostatistics and Analyses Ltd, he has been in charge of a young team of developers. His knowledge of web-based technologies and their application is invaluable in designing the architecture, implementation and testing of the Clade-IS.

Supervisory Board

The Supervisory Board is the supervisory authority of IBA Ltd. The Supervisory Board is obliged to supervise the company’s management, participates in strategic decisions relevant to the company and takes initiatives for the company’s future operation.

Members of the Supervisory Board

Prof. Ladislav Plánka, MD, PhD
Chairman of the Supervisory Board, Chief Physician of the Department of Paediatric Surgery, Orthopaedics and Traumatology at the University Hospital Brno, Professor at the Masaryk University

Prof. Martin Bareš, MD, PhD
Member of the Supervisory Board, Vice-Rector for Academic Affairs of the Masaryk University, Deputy Chief Physician of the 1st Department of Neurology at the St Anne's University Hospital Brno

Marta Valešová, MSc, MBA
Member of the Supervisory Board, Bursar of the Masaryk University

Prof. Petr Dvořák, PhD
Member of the Supervisory Board, Vice-Rector for Research of the Masaryk University, Head of the Department of Biology at the Faculty of Medicine of the Masaryk University

Assoc. Prof. Petr Štourač, MD, PhD
Member of the Supervisory Board, Chief Physician of the Department of Paediatric Anaesthesiology and Resuscitation at the University Hospital Brno

Ownership structure

The current ownership structure consists of three associates, and the Masaryk University is one of them. Therefore, the Masaryk University has still the possibility to influence the company’s management and operation, it has the right to call a meeting of associates and to propose measures.

GDPR

GDPR logo

The IBA Ltd staff has been dealing with the issue of personal data protection for many years. This is due to the fact that many projects managed by IBA Ltd involve processing of data which might possibly be (or actually are) sensitive data. The issue of personal data protection has been addressed by the introduction of ISO 27000, ISO 20000, standard operating procedures (SOP) and a number of procedures that deal with the protection of personal data comprehensively and in accordance with GDPR, the new regulation of the European Commission. All projects have been managed properly and in compliance with the current legislation. IBA projects have been checked several times by the Office for Personal Data Protection and no misconduct was ever proven.

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.

Institute of Biostatistics and Analyses, Ltd.