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WHO WE ARE...IBA is an SME based in Brno, South Moravian Region, Czech Republic

IBA was founded in March 2014 – as a spin-off company of Masaryk University, which is the second largest public university in the Czech Republic and the leading higher education institution in Moravia.

With the previous academic background, IBA has been an essential partner for clinical researches - local and international - including medical expert societies, pharmaceutical companies and specific grant teams – for more than 15 years.

IBA focuses mainly on data management in clinical research projects, real-world evidence projects, organization and management of clinical trials, particularly non-interventional clinical studies and healthcare registries.

IBA‘s main activity is complemented with related services such as analysis of data, cost-effectiveness analysis, market access support, pharmacovigilance, technology-enhanced medical training and development of tailored software products.

The staff at IBA comprises of 50 employees.

Our

mis

sion

s

To provide reliable data management services

in the healthcare and life sciences industry.

To perform instructional data analysis

for enhanced decisions.

To innovate IT solutions for intuitive

and secure user experience.

To build a strong reputation among

scientists and healthcare professionals.

datamanagement

dataanalysis

information technologies

projectmanagement

To provide reliable data management services

in the healthcare and life sciences industry.

To perform instructional data analysis

for enhanced decisions.

To innovate IT solutions for intuitive

and secure user experience.

To build a strong reputation among

scientists and healthcare professionals.

datamanagement

dataanalysis

information technologies

projectmanagement

To provide reliable data management services

in the healthcare and life sciences industry.

To perform instructional data analysis

for enhanced decisions.

To innovate IT solutions for intuitive

and secure user experience.

To build a strong reputation among

scientists and healthcare professionals.

datamanagement

dataanalysis

information technologies

projectmanagement

To provide reliable data management services

in the healthcare and life sciences industry.

To perform instructional data analysis

for enhanced decisions.

To innovate IT solutions for intuitive

and secure user experience.

To build a strong reputation among

scientists and healthcare professionals.

datamanagement

dataanalysis

information technologies

projectmanagement

dataanalysis

project management

information technologies

datamanagement

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IBA – Global service

IBA develops and runs information systems for collection, validation and analysis of clinical data, mostly by means of web-based technologies.

IBA provides complete services in clinical research projects, including trial or registry design, CRF/eCRF proposal, document comple-tion and communication with regulatory authorities, ensuring expert guarantee by professional medical societies, data reporting and study monitoring.

IBA has a long-standing and privileged collaboration with two university hospitals in Brno and with several labs inside the Central Eu-ropean Institute of Technology (CEITEC).

The Data Analysis department at IBA has extensive experience in data fusion, data analyses and multimodal imaging methods, ob-tained also through professional stays at the University Medical Centre Utrecht and Imperial College London.

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IBA GLOBAL SERVICE

Data collection

RWE/RWD projects

Data analyses

Pharmacovigilance

Clinical data management services

Project management

Education and lectures

Software development

Non-interventional studies

Contract clinical research and health registries

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Our

focu

s

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OUR SERVICES

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Retrospective and prospective data collection and data analyses

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Retrospective and prospective data collection and data analyses

Cross-sectional studies (chart reviews) Single-time retrospective data collection monitoring the occurence of the disease and risk factors at the same time• Quick answer to research questions and objectives of the study• Safe in terms of requirements of regulatory authorities• Safe in terms of GDPR – anonymous data. In case of remote data monitoring, data can be viewed as pseudonymous• Potential for publications

Prospective data collections • Non-interventional studies• Clinical registries• RWE data collections

Data extracts from hospital databases• Analyses of data from selected hospitals, selection based on the size of the centers and the number of patients treated

- a representative sample• Safe in terms of GDPR - data without identifiers and personal data• Safe in terms of ethical approach and regulatory activities

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Non-interventional studies and secondary data use studies (SDU)

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Non-interventional studies and secondary data use studies (SDU)

Non-interventional studies

• Prospective or retrospective-prospective design• Medicinal product used in accordance with SmPC• Time-bound to 2 to 5 years• Application of GPP rules• Collection of primary data (observational studies and registries) • Interviews and questionnaires can be performed as a part of a routine clinical practice

SDU

• Analyses of already collected data, registries can be used as appropriate SDU data sources • Pooling of countries / registries data• National and international analyses -> meta-analyses• Protocol and the other processes and documentation according to GPP• Publication potential

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Contract clinical research and health registries

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Contract clinical research and health registries

• Clinical projects run by IBA are coordinated by the Department of Clinical Projects. This department arranges all: sponsors, scientific leadership, internal communication within the company, i.e. communication with relevant departments, external communication, regulatory and legislative activities.

• All projects solved within contract clinical research are implemented in accordance with national and international recommendations and standards in force, ethical principles and rules for handling of intellectual property.

• IBA has long-term experience in management of health registries in many diagnostic and therapeutic areas, such as oncology, hemato-oncology, rheumatology, gastroenterology, neurology, pneumology, immunology, cardiology and pathology.

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Real–world evidence/data (RWE/RWD),market access and market research services

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RWE/RWD projects

IBA provides support to real-world evidence (RWE) research and is able to ensure comprehensive services in this area. IBA ensures counselling and data processing, or even requests for setting the price, reimbursement, and conditions for reimbursement of medici-nal products.In particular, we offer:Real-world evidence/data (RWE/RWD)• collection of data in a real population• analyses of therapeutic procedures, potential by regions• preparation of “tailored value” of a medicinal product for all regulators and decision makers in the system

Comprehensive market analyses (potential, decision makers, key opinion leaders)Sales force effectivenessCompleting data for setting prices and reimbursements, or a comprehensive arrangement of the entire process• describing the epidemiology of a concrete condition• mapping of therapeutic procedures• analysis of the most appropriate position of a medicinal product in the treatment algorithm• counselling in the strategy of getting the maximum price and the amount of reimbursement from the public health insurance• preparation of the overall strategy in submitting the application• searching for price referencing within the EU• performing the cost-effectiveness analysis and the budget impact analysis

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Project management

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Project management

IBA provides services in the areas of organization and management of clinical trials, non-interventional studies (NIS), clinical regist-ries, and research projects.

Our typical project manager is responsible for technical and administration aspects of a study defined by the client, and is the key person in the communication between the client and the project team. In particular, we offer:• help with both study design and study protocol• proposal of appropriate study centres – site feasibility• outsourcing of study coordinators• processing the documentation according to regulatory and legislative requirements• cooperation with ethics committees and with state authorities• development and creation of case report forms (CRF, eCRF)• development of an electronic system for data collection including data validation, management of user accounts, data reporting etc.• ensuring pharmacovigilance during the study• data processing and analysis• medical writing, ensuring medical aspects of the project• consultations and training

The projects are administered and the relevant study documentation is processed according to implemented ISO norms, national and international standards, legal standards and good clinical/pharmaco-epidemiological practice (GCP/GPP).

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Clinical data management

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Clinical data management

Clinical data management is a critical phase in clinical research. Correct and proper data management leads to production of high-quality, reliable, and statistically sound data.Good credibility and correctness of clinical project result is strictly dependent on quality of collected data. Data management containing data capture, data processing, data validation and data storage has strong impact on the clinical project results. Our open-minded expe-rienced data management team can offer: • CRF creation. We can simply create the CRF according delivered draft. We can also compose the CRF in a way significantly simplifying

the work of investigators focusing on collection of data in best quality. • eCRF creation. Proceed from basic CRF structure we will add a database structure, parametric definition of variables and relevant

functionalities to build eCRF exactly for your project. • DC database. Internally developed professional online EDC system allowing us to manage various scale of clinical projects (IIS, Registries, NIS,

Clinical Trials). Common and advanced functionalities like data entry, data validation and verification, queries management, randomization, flexible user access policy, extensive code lists integrated into database, various language mutations, audit trail, etc. included.

• Data validation. We will prepare for you the list of validations tailored for your project. We know that each project is different. All validations are smartly planned, precisely programmed and carefully tested.

• Advanced work with data. We will manage medical coding in order to precisely analyze adverse events or concomitant medication. We will compare data in our clinical database with data in safety database and then guarantee your safety analyses will be performed on correct data.

• Obviously,youwouldliketohaverealpictureofprojectprogress.Enrollment report is the basis. We can prepare for you customized report tailored according your wishes.

• Documentation. Providing relevant documentation like Data Management Plan or Data Validation Plan is a matter of course.

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Pharmacovigilance

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Pharmacovigilance in the projectsDrug safety (pharmacovigilance) is frequently monitored in clinical registries and in non-interventional studies.

Monitoring of drug safety is very often among the primary or secondary objectives of a specific project. We are able to provide an au-tomated on-line reporting of adverse events and/or adverse effects. Pharmacovigilance procedures also involve safety reconciliations, i.e. comparisons between records of adverse events in the registry and records in the investigator’s safety database.

Our activities in the area of pharmacovigilance are in accordance with legislative and regulatory requirements.

In particular, IBA provides:

• pharmacovigilance activities as part of a clinical project• medical and safety services according to the sponsor’s plan• CRF/eCRF revisions from the point of view of contractual stipulations on pharmacovigilance• adverse event monitoring, reporting and reconciliation

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Data analysis

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Data analysis

IBA has a large and highly experienced team of biostatitians and data analysts. In particular, we offer:

Support in the stage of protocol designing

• preparation of statistical parts of the protocol• processing the power analysis and sample size determination• CRF review with respect to defined aims• randomization, allocation list creation and integration with EDC system Clade-IS • Statistical Analysis Plan (SAP) creation

Data analysis

• periodical reports or on-line visualization of entered data• analysis of clinical data, processing of analytical reports respecting GCP ICH E9 guideline• evaluation of real world data, including the patient’s quality of life and the patient’s satisfaction with treatment• processing of pharmacoeconomic analyses (CUA, CEA, BIA, CMA)• collaboration with medical writers to assure proper interpretation of results and their publication

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Education and training

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Education and training

IBAofferseducation in thefieldofdataanalysis,datamanagementandprojectmanagementofnon-intervenitonalclinical studies in the form of lectures and seminars.We organize customized trainings fully tailored to the needsoftheclientorgeneraltrainingsfortheprofessionalpublic.

Customizedtrainings• Trainings fully tailored to the needs of the client• Statistics training focused on the statistical methodology, data interpretation and interpretation of study results• Statistics training courses are essential for anyone who has a quality-related role • Data management training focused on eCRF creation, data quality and methodology • Data management courses can help you understand how to select, collect, manage, and analyze organizational data• Project management training focused and adapted to non-interventional clinical studies (NIS)• You will learn how to manage NIS, set-up milestones, do risk management, allocate staff and budgets, deal with clients and contracts• We also focus on more professional skills such as how to write protocol according to GPP, how to manage study related documen-

tation and deal with regulatory and legislative activities

Trainingblocks• General statistical and data management training for the professional public

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OUR REALIZED PROJECTS

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TULUNG Registry of non-small cell lung cancer treatment

Guarantor:Prof.JanaSkřičková,MD,PhD.CzechSocietyforOncologyCzechPneumologicalandPhtisiologicalSociety

Projectobjectives:• Monitoring the overall number of NSCLC patients in the Czech Republic treated with the expensive treatment• Assessment of effectiveness of targeted therapies and of applied treatment regimens• Analysis of patients‘ survival in relation to monitored clinical factors• Assessment of safety of targeted therapies

Publications,articlesinscientificjournalsandconferenceabstractsThe TULUNG registry is a project merging previous clinical registries Avastin, Tarceva, and Pemetrexed. The list providing an overview of selected publications in English, the full list of publications linked to the TULUNG project and the list of publications resulting from these projects is available on the website tulung.registry.cz

Startoftheproject:2011End date of the project is not determined.

Numberofcentres:14Numberofrecords/follow-ups/patients:intotal: approx 6600per year: 800 - 900

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IBA GLOBAL SERVICE

tulung.registry.org

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CREDITCzech Register of IBD Patients on Biological Therapy

Guarantors:

Prof.MilanLukáš,MD.,PhD.MartinBortlík,MD.,PhD.CzechGastroenterologicalSociety

Non-interventional multicentric retrospectively-prospective longitudinal follow-up of patients treated by biological medication for idiopathic bowel inflammations.

Startoftheproject:2016End of the project is not determined

Numberofcentres:30

Numberofrecords/follow-ups/patients:intotal:approx. 3000peryear:approx. 1500

Primaryendpoints:The main purpose of the project is monitoring of the total count of patients treated with biological therapies in the Czech Republic.

Secondaryendpoints:Further goals include evaluation of the effects of the biological therapy, evaluation of the quality of life through QOL questionnaires, evaluation of therapeutic models and monitoring of the length of biological therapy of IBD patients.

Publicationsandpresentations:PEARLS GI Gastroenterology Standalone Meeting, 19.–21.1.2017, Vienna, Austria, speaker Martin Bortlík, MD, Ph.D.Committee on Health Care, Chambre of deputies Parliament of the Czech Republic, 7.3.2017, speaker prof. Milan Lukáš, MD, CSc.Workshop of Paediatrics gastroenterology and nutrition, 5.-7.10.2017, EA Hotel Kraskov, Czech Republic, speaker Martin Bortlík, MD, Ph.D.RUŽGAD 2017, 10.11.2017, Bratislava, Slovakia, speaker Martin Bortlík, MD, Ph.D.

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IBA GLOBAL SERVICE

credit.registry.org

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REPAR Czech nationwide registry of patients who have been treated with growth hormone

Guarantors:Prof.VáclavHána,MD,PhD.,StanislavaKoloušková,MD,PhD.,CzechEndocrinologicalSociety

Register is divided into children and adults part

Projectobjectives:

• Collection of epidemiological and clinical data on patients treated with growth hormone

• Keeping records on patients treated with growth hormone. Treatment is providing in centers (large health care facilities with experience with this treatment)

• To evaluate safety and effectiveness of therapy with growth hormone for individual diagnoses

• To involve all health care facilities providing treatment with growth hormone in the Czech Republic

• To establish a Czech nationwide portal which would pre-sent the project results, and which might also serve for a mutual communication among involved centers, or for the presentation of their own activities

REPARchildren

Startoftheproject:2013End date of the project is not determined.

Numberofcenters:10

Numberofrecords/follow-ups/patients:intotal: approx 3700peryear:600 - 700

REPARadult

Numberofcenters:9

Numberofrecords/follow-ups/patients:in total:approx 540per year: approxa 100

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IBA GLOBAL SERVICE

repar.registry.org

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NERONausea/EmesisRegistryinOncology

Impact of the Adherence to Antiemetic Guidelines in Cancer Patients Undergoing Repeated Cycles of Either MEC or HEC Regimens in Eastern Europe

Guarantor:Dr.med.MattiAapro,FMHSponsor:AngeliniPharmaOestereichGmbH

StudyObjectives:Primaryobjective: Guideline consistent and guideline inconsistent CINV prophylaxis measured by Complete Response (CR: no emesis and no use of rescue medication) during 120 h after chemotherapySecondaryobjective:Impact of CINV on the Quality of Life in cancer patients receiving MEC/HEC

Startoftheproject:2016Endoftheproject:2019

Numberofcountries: 6Numberofcenters: 36Targetnumberofsubjects: 1150

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IBA GLOBAL SERVICE

nero.healthregistry.org

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Publicationsandconference

Publications of Czech myeloma group in 2017MM and MGUS – 37 publications

More information and the list of publications is available on the website myeloma.cz

RMGInternational clinical registry of patients with monoclonal gammopathies

Guarantors:

Prof.RomanHájek,MD,PhD.Prof.VladimírMaisnar,MD,PhD.CzechMyelomaGroup

Projectobjectives:

The primary goal of the project is creating a parametric database and an information system for the collection and basic analysis of data on diagnosis and therapy of patients affected with monoclonal gammopathy in a routine clinical practice.

Startoftheproject:2006End of the project is not determined.

Numberofcenters:23

Numberofrecords/follow-ups/patients:intotal:approx 9600peryear:approx 800

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IBA GLOBAL SERVICE

rmg.healthregistry.org

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Publicationsandconference

Presentations at international conferences, presentations at Czech conferences, articles in international journals.More information and the list of publications and presentations is available on the website attra.registry.cz

ATTRARegistry of patients with inflammatory rheumatic diseases

ATTRA–AS AnkylosingspondylitisATTRA–RA RheumatoidarthritisATTRA–PSA PsoriaticarthritisATTRA–JIA JuvenileidiopathicarthritisATTRA–SLE Systemiclupuserythematosus

Guarantor:

Prof.JiriVencovsky,MD,PhD.CzechRheumatologicalSociety

Startdate:2001End date of the project is not determined.

Numberofinvolvedcenters:41

Numberofrecords/follow-ups/patientsintotal:ATTRA-AS: approx 3100ATTRA-JIA: approx 900ATTRA-PSA: approx 970ATTRA-RA: approx 4600ATTRA-SLE: approx 150

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IBA GLOBAL SERVICE

attra.registry.org

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OUR PRODUCTS

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ObserNIS web application

Application

• is developed as a useful tool to generate the type of a planned study with respect to the necessary legislative acts• helps define the study design - case-control, cohort, cross-sectional, ...• is a repository of information, documents, and backgrounds for protocol creation• leads the user through individual study steps to create a study protocol• helps create a formatted protocol• minimizes study costs - using this application, the user is able to design and create a protocol by himself/herself

Defining study design• defining a study type using answers to decision tree questions (Wizard)

Creating study protocol• writing protocol chapters - a guide is used to navigate through protocol chapters (Guide)• repository of processes, information, study documentation, attachments• continuous changes can be made to the individual parts of the documentation that will be reflected when generating a new version

of the protocol

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IBA GLOBAL SERVICE

A SIMPLE AND ULTIMATE GUIDE TO OBSERVATIONAL /NON - INTERVENTIONAL STUDIES

ObserNIS is simple and easy solution for NIS de�nition. aThanks our sophisticated algorithm, you can de�ne

precisely type of your study according to standards easily.

This service helps you de�ne for FREE your speci�cclinical research project, prepare all documentation and

generate Protocol as an essential document of clinical study. You have everything in one place. ObserNIS is

your Electronical Trial Master File.

O BSERNIS ©

www.obsernis.comobsernis.com

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Virtual patient

Learningmodality

Virtual patient is an interactive computer simulation of a real clinical situation, or a case created for medical and health education purposes. It is a learning modality that is often used to support skills training, such as clinical decision making and critical thinking.

Virtualpatientdeliverysystem

• Virtual patients can be understood as representations of real world-problems in health care. They represent a narrative form of medical simulations and enable healthcare professionals to simulate important steps in the diagnostic and therapeutic process before exposure to patients.

• Our virtual patient delivery system is an easy-to-use web-based platform. It comprises of a player with elements coming from the world of serious games, an authoring tool, an administration component, storage system, and assessment tools.

Reference project

The ca-ledviny.cz project represents a series of virtual patients with renal cell carcinoma. Educational content has been created for the purpose of lifelong learning for physicians and healthcare professionals, particularly in the fields of oncology and urology. All the cases have a linear pathway, instant feedback and a score generator that brings our virtual patients closer to the world of serious games.

IBA GLOBAL SERVICE

virtualni-pacient.cz

ca-ledviny.cz

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CLADE-IS

• CLADE-IS (Clinical Data Warehousing Information System) – a software product developed by IBA - belongs to the class of the most modern and progressive EDC systems industrialized on the grounds of web technologies.

• It comes with Entity–Attribute–Value model of the database allowing encoding data structures and entities with sparse characte-ristics. This is exactly the case of data entities in clinical research databases where the number of parameters or attributes used to describe an entity is potentially large, but the actual number of the applied attributes with assigned values is relatively low.

• At a high level, the openness of the data model means that CLADE-IS is in fact a robust platform for design and deployment of stan-dalone EDC systems for data collection and management in clinical studies of various types, in a wide range of clinical fields.

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REFERENCES

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CONTACT

Institute of Biostatistics and Analyses, Ltd.

Poštovská 68/3, 602 00 BrnoCzech Republic

Contact us:

info@biostatistika.cz+420 515 915 100

Helpdesk 8–16 h

helpdesk@biostatistika.cz+420 515 915 100