Leader on the Polish market in providing professional and innovative solutions in the area of clinical trials and observational studies, statistics, medical software, telemedicine and R&D.
Commercial research unit with status of a Research and Development Centre (R&DC) granted by the Minister of Entrepreneurship and Technology.
years of experience
Over 50 cooperating entities.
Projects implemented in various fields:
Commercial Clinical Trials (CCT) and Investigator Initiated Studies (IIS)
The range of support we provide for phase I-IV of clinical trials:
We support our clients at every stage of work by offering comprehensive preparation and service of prospective and retrospective studies.
One of the best statistical teams in Poland.
Statistical services for scientific and commercial research programmes in the field of biostatistics, statistical analyses, data mining and data management.
Statistical analyses in accordance with the requirements of the Master Journal List. Statistical consulting.
Our experts will prepare every
methodological aspect of planned
DESIGNING THE STUDY:
Good Data Management is the key to the success of the study.
Compliance with international standards
(Good Clinical Data Management Practices, Version 4, October 2005, Society for Clinical Data Management).
Configuration, validation, cleaning and database blocking
Database testing, UAT
Development/update/ validation of eCRF
Ongoing quality control
User account management
Formal and statistical verification
Identification of outliers
Data management services on external EDC systems
Cooperation with international research teams
Electronic Data Capture System, EDC
The platform is recommended by professionals on the Polish market.
MODERN TECHNOLOGY FOR BIG DATA
The world is changing, and so are we.
Compliance with the guidelines FDA Title 21 CFR Part 11
Original BioStat® system (no additional license)
Interactive Web Response System (IWRS)
The possibility of integration with laboratories
Unique design of each study
Unlimited number of studies
Interoperable and scalable platform
Integration with the online contracting system
Full validation and specific tests
The success of any study depends on the
excellence of the developed eCRF and well
provided data management services.
We optimize research processes by providing the
best and proven solutions.
We are moving clinical trials and observational studies into a digital world.
electronic Patient Reported Outcome, ePRO
Our digital solutions are an alternative to paper patient diaries.
How does BIOSTAT ePRO work?
Comprehensive solutions for the management of a doctor's and physiotherapy office.
Telemedicine platform - online consultation
Medfile® EDM integration
Telemedicine connects professionals with patients online.
Authorised patient consent
Authorized service to collect approvals in accordance with the General Data Protection Regulation. A simple way to obtain the required signatures and maintain relationships with customers.
Pursuant to Article 245 of the Code of Civil Procedure, a document drawn up in writing and in electronic form constitutes evidence that the person who signed it has made a declaration within the document.
Shortening the time for formal matters, increasing the duration of specialist consultations.
A platform for creating, implementing
and managing opinion and satisfaction
Fast and intuitive electronic survey.
Consumer panel for surveys.
A nationwide consumer base allowing for the implementation of a wide range of market research, opinion polls and surveys, focusing on online surveys.
CATI, CAWI, CAPI research software.
Management, creation and implementation of online surveys and surveys from a single platform.
Implementation of telephone surveys, supervising the work of remote interviewers
Reaching out to selected, even small or highly specialised groups of respondents
Comprehensive solutions for mobile devices
A favourable tax instrument
in the hands of BioStat®.
The most attractive form of support for R&D activity on the Polish market. An uncomplicated mechanism to deduct from the tax base costs incurred for R&D activities, the so-called eligible costs.
If you improve your technologies, products, services or create new ones from scratch with BioStat®, you may meet the conditions for conducting R&D activities eligible for the relief.
The condition for taking advantage of the relief is to conduct development activity (it is not required to conduct scientific research, have the status of a R&D centre or cooperate with scientific entities).
Ultimately, the costs of research conducted by the BioStat® Research and Development Centre are up to 20% lower*..
BioStat® is one of the narrow group of entities that are entitled to issue an Innovation Opinion according to the standards described in the Oslo Manual (Oslo Manual 2018. Guidelines for Collecting, Reporting and Using Data on Innovation.)
* depending on the tax rate, income in a given month and costs incurred
Preparation time: about 10 days
Cost: from several to over a dozen thousand zlotys
People are the greatest strength of BioStat® and it is their expert knowledge that the BioStat® brand value is based on.
A specialized team of statisticians, programmers, managers with a background in medicine and biology, biotechnology, bioengineering, chemistry, biostatistics with many years of experience in designing and developing systems, applications, studies.
Dr inż. Ewa Tkocz-Piszczek
Pharma Division Director
Dr Marian Płaszczyca
Head of Statistics and DM
Dr Monika Kurpanik
Dr Sebastian Musioł
Dr Małgorzata Płaszczyca
Senior Project Manager
Any content included in the following offer (slogans, texts, pictures, etc.) are under legal protection on the basis of the Act on Copyrights and Related Rights of the 4th of February 1994 (uniform text: Journal of Laws 2006, no 90, position 631 with later alterations). Without the author’s permission it is prohibited to i.e. duplicate the content, copy, reprint, storage and processing with the use of any electrical media, both in whole and in part. Further distribution is prohibited, as it stated in the Act on Copyrights and Related Rights (art. 25 §1 section b) of the 4th of February 1994.