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01 CRO 02 Clinical trials 03 Clinical trials of medicinal products 04 Clinical trials of medical devices 05 Observational studies 06 Medical Registers 07 eCRF
08 Data management 09 Real world data 10 Statistics 11 Trainings and consulting 12 Research and Development 13 Market Research

BioStatistics
eCRF | Clinical Trials | Registries

In accordance with FDA standards

Active studies

Our biostatistics center provides comprehensive services in the planning, organization, and execution of research, as well as data processing for various research projects. With 16 years of experience in collaboration with pharmaceutical and medical companies, we offer our clients support in the following activities:

  • Clinical, epidemiological, and bioequivalence studies
  • Observational studies, PMS (Post-Marketing Surveillance), educational studies
  • eCRF.bizTM (electronic Case Report Form) for clinical trials
  • Medical registries
  • Contract Research Organization (CRO)
  • Data analysis

Our services are not only utilized by well-known pharmaceutical corporations but also by top Polish research institutions. We have undertaken research projects in various fields, including oncology, invasive cardiology, and neurology. We have processed data from DNA sequencing and conducted gene expression analyses. In our day-to-day research practice, we employ state-of-the-art bioinformatics tools (such as Blast, Phred/Phrap, Bioconductor). Our team consists of experts in biostatistics, bioinformatics, and data management, and their analyses have been published in journals listed in the Master Journal List (Philadelphia List).

The high qualifications, scientific preparation, and years of experience of our team in collaboration with clinicians and companies in the pharmaceutical and biotechnology industries ensure the credibility and reliability of our services for our clients. We carry out our activities in accordance with the principles of Evidence-Based Medicine (EBM).

01Study Design

  • Development of the statistical section in the study protocol
  • Preparation of the Statistical Analysis Plan (SAP), including tables and listings
  • Sample selection and statistical methods, with statistical justification

01

02

04

03

02Data Management

  • Development of the database structure
  • Data collection and data quality control
  • Electronic Case Report Form (eCRF.bizTM)
  • Data entry and coding

03 Statistical analysis:

  • Interim reports and analyses
  • Dependency/comparative analyses
  • Survival analyses
  • Correlations, tests, regression analysis
  • Discovery of diagnostic rules

We conduct research programs using our own innovative research platform:


Logo eCRF.biz

The eCRF.bizTM software enables the execution of research at the highest level. The system was designed with pharmaceuticals, biomedicine, and clinical medicine in mind. The platform provides secure, encrypted access to data in compliance with Title 21 CFR Part 11 guidelines. The program offers automatic data quality and completeness checks during data registration. It also features advanced reporting and tracking mechanisms that allow real-time monitoring of research progress. Through the use of comprehensive control mechanisms, audit trails, data queries, and data backup, enhanced with a statistical module, the data in the system are not only secure but also prepped for even the most complex statistical analyses conducted by our team.

What's new in eCRF.bizTM NEW!

eCRF.bizTM - our system for conducting observational and clinical trials - has gained a new functionality. This is a reporting system based on the world's most popular open-source statistical package, R. Through integration, studies conducted in the eCRF.bizTM system can be enriched with reports of any level of complexity.

This capability allows not only the presentation of data regarding the progress of the study or safety parameters, such as listings of adverse events but also the generation of custom comparisons of analyses and statistical models according to the client's requirements. This includes analyses using multifactorial models, logistic regression, linear regression, and even Bayesian analysis. The report can take the form of a PDF file or a web page and can include tables, charts, and even descriptions updated as the study progresses. In addition to the transparency offered to the study sponsor, this solution allows for the application of modules for comparing the results of a particular center with other participating centers in the study - this can be useful for doctors who can anonymously compare the therapeutic solutions they are using with those of their colleagues from other centers. Another application is the generation of a real-time interim analysis template, which is up to date at any given moment without the need to engage a team of statisticians - this can be useful in early detection of anomalies or deviations from the protocol or even unexpected increases in the frequency of adverse events associated with the investigational drug.

The use of the R language allows the entire process of report preparation to be entrusted to statisticians, eliminating the need to engage a team of programmers. Furthermore, the generated code can be utilized to create the final report.

Our goal is to maximize the accessibility and readability of information collected in the system for our clients and users.

Recommendations:

Amgen

Amgen
Rekomendacje

„The cooperation has concerned survey organization, consulting and statistical analysis of quantitative research. We are indeed thankful to Rafal Piszczek for his reliability and professionalism in ding his duties as well as for his creative contribution on the projects being conducted by Amgen.”

Military Medical

Military Medical
Rekomendacje

„I confirm that I have dealt with Mr Rafal Piszczek since 2006, during which time he has provided us with excellent support in the area of medical data analysis and the use of advanced statistical tools. I can confidently recommend Mr Rafal Piszczek as a solid and reliable expert in this field.”

Mundipharma Polska Sp z o.o.

Mundipharma Polska Sp z o.o.
Rekomendacje
„The BioStat company performed their tasks professionally and always on time. The technical and logistic solutions always meet our substantial meetings and are intuitive for a system user. Any doubts or concerns are explained on an on-going basis without wasting time.”

Mabion

Mabion
Rekomendacje
We have worked with BioStat company for over two years now and we mostly deal with clinical trials. They have created an e-CRF system that meets our research requirements as far as maintenance and system administration is concerned. The BioStat company perform their tasks reliably and in due time.

Clinic and the Cardiological and Non-invasive Cardiology Rehabilitation Centre

Clinic and the Cardiological and Non-invasive Cardiology Rehabilitation Centre
Rekomendacje
Quick, professional and on-time support in statistical analysis of the material needed for statutory work conducted by The Institute of Cardiology in Warszawa. It’s significant that the results were clear and comprehensible for anyone involved. I can recommend this company with complete conviction.

The Oncology Centre

The Oncology Centre
Rekomendacje
The contractor’s task was to carry out a quantitative study on social opinion on the level of health awareness and health habits among specified target groups. The project “45+” in the field of genito-urinary diseases. The study was conducted without reservation and in accordance with the agreement signed.

Child Health Centre

Child Health Centre
Rekomendacje
In my opinion, the BioStat company is of high and proficient knowledge, basis of merit and most of all – we appreciate their availability. We could always be provided an explanation on unclear statistical knowledge. They always put the results in a comprehensible way needed to be implemented in clinical practice. We also strongly appreciate their graphic support. 

Central Institute For Labour Protection

Central Institute For Labour Protection
Rekomendacje
This company conducted our survey research as well as the statistical analysis concerning risk assessment for handling portable computer equipment in a timely manner. The result met with our positive feedback.

The Institute of Occupational Medicine

The Institute of Occupational Medicine
Rekomendacje

This company carried out Polish nationwide survey research . We consider their work as reliable and on-time as well as in accordance with the agreement. Additionally, we do not raise any objections to the materials presented. 

ISN Pharma

ISN Pharma
Rekomendacje
„We have been using BioStat services for a long time as far as creating eCRF questionnaire for clinical trials is concerned or its handling, assumptions, documentation and research merit. The system created is very clear and user friendly.”

Wroclaw Medical University

Wroclaw Medical University
Rekomendacje
„I am highly satisfied with their professional and on-time statistical data analysis which is significant while composing a PhD thesis. What deserves credit is their high proficiency level, as well as flexibility in meeting customers’ needs.”  

Novartis Poland Sp. z o.o.

Novartis Poland Sp. z o.o.
Rekomendacje
„The cooperation with BioStat was smooth. The company always prepares all elements of the agreements on time, with no delays. The contacts with BioStat were always very professional and the quality of their work was very high.”

The Institute of Psychiatry and Neurology in Warsaw

The Institute of Psychiatry and Neurology in Warsaw
Rekomendacje
The statistical analysis referring to multiple judicial-psychiatric-psychological opinion-giving was conducted uncritically and in accordance with the agreement.

The Clinic and Department of Orthopaedics and Traumatology at the Medical University of Lublin

The Clinic and Department of Orthopaedics and Traumatology at the Medical University of Lublin
Rekomendacje
The BioStat team proved themselves in being proficient at medical issues. They were a party to the statistical research methodology design, dealt with calculations as well as they verified other researchers’ results.

National Veterinary Research Institute

National Veterinary Research Institute
Rekomendacje
The contractor consulted their e-database components with us to meet the ordering server requirements what allowed us to continue the research in the following years. The e-monitoring program was designed conscientiously and professionally. 

Pfizer Polska Sp. z o.o.

Pfizer Polska Sp. z o.o.
Rekomendacje
„We received an excellent support in the area of statistics, data analysis and the use of advance in medical research projects. The BioStat company used a very clear language and a variety of methods to maximize our understanding and to ensure that statistical theory and practice were integrated.”

The Institute of Haematology and Transfusion Medicine

The Institute of Haematology and Transfusion Medicine
Rekomendacje
„The research results provided by BioStat company are promising, especially that there is a small number of such research done on clinical application. The results have been presented during some national and international conventions on haematology and haematopoietic stem cell transplant. Our collaboration is brilliant. We are in permanent contact and we are hoping for further fruitful and professional cooperation.”

Medical University of Warsaw

Medical University of Warsaw
Rekomendacje

During our collaboration, the company fulfilled its duties professionally and diligently. The company's employees are perceived by us as reliable professionals who are fully committed to their work. Throughout our cooperation, they demonstrated understanding and patience in adapting to project changes.

Helimed

Helimed
Rekomendacje

We worked with BioStat to survey the quality of service and patient feedback in our facilities. The service was performed carefully and in accordance with the terms of the contract.

Celon Pharma

Celon Pharma
Rekomendacje
„We have used services of Rafal Piszczek (from BioStat company) since 2006 in the scope of medical statistics. During our cooperation, Rafal Piszczek has performed his services in a professional way. We are indeed thankful for his reliability and recommend him as a professional statistician.”

Johnson & Johnson Poland

Johnson & Johnson Poland
Rekomendacje
„In 2015, the BioStat company designed a statistical analysis for Johnson & Johnson (LifeScan) research project. We consider collaboration as positive. The tasks were completed reliably and in a timely manner. I recommend their professional service and timeliness.”
 

Domański Zakrzewski Palinka

Domański Zakrzewski Palinka
Rekomendacje
„Within the job commissioned, we asked your company for an analysis of the price level for a medicinal product concerning the competitive price. The task was carried out diligently, conscientiously and in a complex way.”

Lek Polska Sp z o.o.

Lek Polska Sp z o.o.
Rekomendacje
„During our cooperation, BioStat company perform their service in a professional way, upright and keeping deadlines as well the quality of service was on a very high level. BioStat company approach to our order in special individual way and execution of the project meets our expectations. While the contact and cooperate with BioStat, we meet with kind, on time and flexible treatment.”

MSD

MSD
Rekomendacje
„Reaching ambitious goals is possible thanks to our business partners professional support. We consider BioStat company as one of our recommendable partners. In the period 2007-2008 BioStat designed three research projects for MSC Polska on the basis of in-depth interviews (IDI). The projects were carried out correctly, on target and with a complete engagement of their team members.”

Institute of Economics, Polish Academy of Sciences

Institute of Economics, Polish Academy of Sciences
Rekomendacje
„The statistical analysis of the data and study on the econometric model within the research project entitled ‘Development paradigm and the effectiveness of innovative structural aid from the EU’ was carried out very conscientiously. The quality and timeliness provided within this taskdemonstrate extremely high competencies and professionalism of the BioStat team.”

Thea Polska Sp. z o.o.

Thea Polska Sp. z o.o.
Rekomendacje

We recommend BioStat in the implementation of quantitative and qualitative segmentation studies and broadly undertaken marketing research. The cooperation to date has been successful and flawless. The company has provided expert advice and full professionalism in the provision of research services. In addition, BioStat's staff stood out for their high level of knowledge and competence. It should also be emphasised that BioStat was very flexible in planning and proposing solutions, which is highly appreciated in this day and age.

Chiesi

Chiesi
Rekomendacje
„Regardless any on-going research, the BioStat company, by so far, has carried out for us a dozen statistical analyses basing on the data we gathered from other research. Each of the analysis commissioned was carried out quickly and firmly. Currently, BioStat is our preferable statistical service provider. Their company is definitely recommendable.”

Novascon Pharmaceuticals Sp z o.o.

Novascon Pharmaceuticals Sp z o.o.
Rekomendacje
„The BioStat company has again demonstrated high responsiveness towards the client’s needs, working hours beyond the standards if the situation so required and flexibility concerning results presentation that was needed at any given moment. Their engagement in unexceptionable contact with clients as well as the scope of their knowledge gives the client a sense of being in good hands.”

Medtronic

Medtronic
Rekomendacje
„What is extremely valuable in modern market conditions is to find adequate companies to collaborate with, that would know our needs, and sometimes, they would even use their experience and professionalism to provide support in issues which we are not quite familiar with. We are pleased to recommend the services that BioStat provides especially to these companies that are trying to find a solid business partner to collaborate with. We are convinced that you can count on them. We consider BioStat as a professional company with wide experience, that ensures continuous cooperation and development for their business partners.”

Medical University in Lublin

Medical University in Lublin
Rekomendacje
„In late 2011, the BioStat company carried out a study concerning the attitudes towards genetic information and biobanking on behalf of the Faculty of Humanities at the Medical University in Lublin within the scientific grant given to dr. Jakub Pawlikowski by MNiSW. I confirm that the company has carried out the task reliably and in a timely manner, demonstrating professionalism at the same time and providing a complete research report along with the statistical analysis.”

The University of Lodz

The University of Lodz
Rekomendacje
„I confirm that the BioStat company carried out the research within a project entitled: “The role, position and scope of functioning of Staff Committees in Polish employment relationship system”. The service provided was conducted in accordance with the schedule set in the agreement along with due diligence, professionalism and engagement. As far as the current collaboration with BioStat is concerned, it needs to be said that their company is highly recommendable.”

SGH Warsaw School of Economics

SGH Warsaw School of Economics
Rekomendacje

BioStat undertook a qualitative study on the measurement of human capital in Polish companies, together with transcriptions and preparation of the study report. The subject of the contract was performed in accordance with the provisions of the contract and with due diligence.

Military Medical Institute

Military Medical Institute
Rekomendacje
„On behalf of the Department of Marine and Hyperbaric Medicine at the Military Medical Institute, I am pleased to give references to BioStat company, that in a professional way took up the task for designing an advanced tool using the rules of Bayes statistics (…). The project was conducted in a timely manner and the collaboration was smooth, without any problems.”

Milton Essex

Milton Essex
Rekomendacje
„The quality of IT solutions provided by BioStat exceeds the majority of alternative eCRF systems as far as their functionality and safety are concerned. I express recognition for the terminable and professional organisation of any task commissioned. We recommend the BioStat company services to all entities working in the R&D sector.”

Military Medical

Military Medical
Rekomendacje
„I confirm that I have dealt with Mr Rafal Piszczek since 2006, during which time he has provided us with excellent support in the area of medical data analysis and the use of advanced statistical tools. I can confidently recommend Mr Rafal Piszczek as a solid and reliable expert in this field.”

Medical University in Lublin

Medical University in Lublin
Rekomendacje
„I have known and collaborated with Rafal Piszczek, member of our research team, since January 2005. I am absolutely convinced, Rafal Piszczek is a very good candidate for any responsible work in the area of statistics.”

EGIS

EGIS
Rekomendacje
„The BioStat company provides professional support and services. The BioStat team members have essential knowledge and competencies, as well as they exhibit openness and readiness towards solving problems or any doubts.”

Amgen

Amgen
Rekomendacje
„The cooperation has concerned survey organization, consulting and statistical analysis of quantitative research. We are indeed thankful to Rafal Piszczek for his reliability and professionalism in doing his duties as well as for his creative contribution on the projects being conducted by Amgen.”

The clinic and Department of Urology and Urological Oncology

The clinic and Department of Urology and Urological Oncology
Rekomendacje
„The BioStat company was helpful in working out the statistical data for a rarely discussed topic in literature that is anabolic substances abuse. The data compilation allowed us to publish some works in leading medical magazines or present the issue at the Scientific Congress of Polish Urological Society.”

Medical University of Silesia

Medical University of Silesia
Rekomendacje

The project and implementation of a database system were entrusted to BioStat company. Thanks to the professional approach of BioStat, which provided support at every stage of system implementation, we were able to quickly use a solution tailored to our needs shortly after the project began.

Łukasiewicz Research Network

Łukasiewicz Research Network
Rekomendacje

I recommend BioStat company for a wide range of statistical services. We have previously utilized BioStat's assistance in analyzing data related to NOEC determination, principal component analysis (PCA), principal component regression (PCR), and redundancy analysis (RDA). It is worth noting that the service was carried out diligently and professionally. BioStat's services are characterized by a high level of quality.

Children's Memorial Health Institute

Children's Memorial Health Institute
Rekomendacje

"I highly appreciate the knowledge, substantive basis, and above all, the availability of the BioStat team. They were always ready to explain complex statistical knowledge, translate the results of statistical tests into practical knowledge necessary for clinical practice. The significant graphical assistance was also appreciated."

Clinic and Department of Cardiac Rehabilitation and non-invasive electrocardiology of the National Institute of Cardiology

Clinic and Department of Cardiac Rehabilitation and non-invasive electrocardiology of the National Institute of Cardiology
Rekomendacje

Fast, professional, and timely assistance in statistical analysis of materials for statutory work conducted at the Institute of Cardiology in Warsaw. The clear and understandable presentation of results was also of great importance. I can wholeheartedly recommend the company.

Department and Clinic of Orthopedics and Traumatology of the Medical University of Lublin

Department and Clinic of Orthopedics and Traumatology of the Medical University of Lublin
Rekomendacje

"The BioStat team demonstrated a thorough understanding of medical issues. They participated in designing the methodology for statistical research, conducted calculations, and verified the calculations of other researchers."

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Selected publications
with the participation of our team of statisticians in respected journals

16

years of experience

1000

research

500

publications

News

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Kontakt

telefon

Phone: (+48) 22 12 28 025
Mobile: (+48) 668 300 664

adres

Sales Office
Aleje Jerozolimskie 96
00-807 Warsaw

adres

Company Headquarters
ul. Kowalczyka 17
44-206 Rybnik

email

E-mail: biuro@biostat.com.pl

Also see:
eCRF functions (7.39MB) eCRF eCRF - functions
CRO
Clinical trials
Drug clinical trials
Medical device clinical trials
Non-commercial clinical trials
Observational studies
Pharmaceutical market research
Research and development
Medical registers
eCRF
Statistics
Biostatistics
Data management
Trainings and consulting
Monitoring
Real-World Data
Digitization of the data collection process
Offer pdf

Frequently asked questions.

Does Biostat provide statistical support for research?

Yes, absolutely. We offer comprehensive statistical support for research. What services are included in this support?

  • Study design
  • Sample size determination
  • Justification
  • Statistical input into the study protocol
  • Statistical analysis plan
What aspects can the client delegate as part of the statistical analysis?

In most cases, our qualified team conducts statistical analysis according to the study protocol, interim analysis, and also provides a graphical presentation of the study results. Our staff is also prepared to prepare a final report on the conducted study.

What types of research can be conducted at Biostat?

Our researchers have extensive experience in conducting marketing research, market research, customer or employee satisfaction surveys, brand awareness studies, and various medical market research. Thanks to our wide-ranging expertise, our team possesses knowledge in various domains and continually updates itself to stay current with all prevailing trends.

During clinical or observational studies, what services are included?

Our entire team provides comprehensive services for both clinical and observational studies. They are responsible for statistical support, preparation of project documentation, eCRF preparation, data management, monitoring, communication with research centers and investigators, project management, and conducting training sessions.

ACTIVE STUDIES & CLINICAL RESEARCH
e-mail
biuro@biostat.com.pl
telephone
+48 668 300 664
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