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





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:


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.


See More

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


years of experience








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


Sales Office
Aleje Jerozolimskie 96
00-807 Warsaw


Company Headquarters
ul. Kowalczyka 17
44-206 Rybnik



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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.

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