Offer 2020

Biostat

Who we are?

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.

+15

years of experience

+70

experts

+2000

studies

+500

publications

+20

audits

Our clients

Over 50 cooperating entities.
icon

Pharmaceutical
companies

icon

Biotechnological
companies

icon

Clinical Research
Organization (CRO)

icon

Academic & scientific-educational units

icon

Medical universities

icon

Hospitals, clinics

icon

Scientific societies
and associations

icon

Medical equipment
manufacturers

icon

Individual clients (scientists, KOLs, etc.)

Therapeutic areas

Projects implemented in various fields:

  • Oncology
  • Gastroenterology
  • Transplantology
  • Cardiology
  • Neurology
  • Allergology
  • Psychiatry
  • Neonatology
  • Diabetology
human
  • Pulmonology
  • Immunology
  • Andrology
  • Proctology
  • Dermatology
  • Ophthalmology
  • Rheumatology
  • Virology
  • Hematology

What we do?

Comprehensive services:

icon

Clinical trials

icon

Non-interventional studies

icon

Medical statistics

icon

Data Management

icon

eCRF.biz™ system

icon

Market research and public opinion surveys

icon

Medical/telemedical applications and platforms

Clinical trials

Commercial Clinical Trials (CCT) and Investigator Initiated Studies (IIS)

The range of support we provide for phase I-IV of clinical trials:

  • eCRF - Electronic Data Capture System, EDC
  • Interactive Web Response System, IWRS
  • Data Management, DM
  • Statistics, Analysis
  • Documentation
  • Monitoring/CRO support
  • Project Management
  • Counseling/consulting

Non-Interventional Study

We support our clients at every stage of work by offering comprehensive preparation and service of prospective and retrospective studies.

  • Study design
  • Preparation and consultation of complete study documentation
  • Contracting of sites
  • Contracting of Investigators (online contracts)
  • Preparation of application for Ethics Committees and Competent Authority, obtaining approvals
  • eCRF preparation
  • Trainings
  • Comprehensive statistical service
  • Data Management
  • Supervision of adverse events reporting
  • Study monitoring
  • Study management and supervision of study
  • Statistics, analysis
  • Assistance in preparing publication of study results
  • Counseling/consulting

Other research projects

  • Medical patient’s records
  • Post Marketing Surveillance, PMS
  • Real-World Evidence studies, RWE
  • Retrospective studies
  • Post Authorization Safety Study, PASS
  • Post Authorization Efficacy Study, PAES
  • Studies of an Rx-to-OTC Switch
  • Case-study research
  • Studies on dietary supplements

Medical statistics

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.

Methods used:

icon

R

icon

SPSS

icon

Python

icon

Basic descriptive statistics

icon

Verification of statistical hypotheses

icon

Interdependence analysis

icon

Multidimensional analyses

icon

Evolutionary algorithms

Professional
statistical services

Our experts will prepare every
methodological aspect of planned
study.

DESIGNING THE STUDY:

  • Sample size calculation
  • Statistical justification
  • Statistical Analysis Plan
  • Statistical input to the Study Protocol
  • Selection of variables and measuring scales
  • Selection of randomization method, randomization list
  • Choice of methods and statistical tests
  • Statistical modeling

DATA COLLECTION::

  • Database design and execution
  • Preparation of data for statistical analysis
  • Statistical and graphical presentation
  • eCRFdesign

DATA PROCESSING:

  • Single and multidimensional statistical analyses
  • Big data analyses
  • Correlations, statistical models, tests
  • Reports and interim analyses
  • Survival analysis (Kaplan-Meier curves)
  • Preparation of the final statistical report
  • Support for CSR creation and publication

Data Management

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).

icon

Configuration, validation, cleaning and database blocking

icon

Database testing, UAT

icon

Development/update/ validation of eCRF

icon

Database Management

icon

Ongoing quality control

icon

User account management

icon

Documentation

icon

Queries management

icon

Reconciliations

icon

Edit checks

icon

Formal and statistical verification

icon

Identification of outliers

icon

Data management services on external EDC systems

icon

Cooperation with international research teams

eCRF.biz

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.

icon

Compliance with the guidelines FDA Title 21 CFR Part 11

icon

Original BioStat® system (no additional license)

icon

Interactive Web Response System (IWRS)

icon

The possibility of integration with laboratories

icon

Unique design of each study

icon

Unlimited number of studies

icon

Interoperable and scalable platform

icon

Integration with the online contracting system

icon

Full validation and specific tests

eCRF.biz
functionalities

The success of any study depends on the
excellence of the developed eCRF and well
provided data management services.

Modules:

  • Data queries
  • Randomization
  • Drug management
  • Reports
  • Analytics
  • Online contracts signing
  • Audit trail
  • Comments
  • Notification
  • User account management
  • Documentation
  • Deviation log
  • MedDRA dictionary integration
  • ePRO – electronic Patient Reported Outcomes

eCRF.biz
benefits

We optimize research processes by providing the
best and proven solutions.

We are moving clinical trials and observational studies into a digital world.

  • Remote access from any web browser without installing software.
  • 24/7 data availability
  • Configurability and scalability of the eCRF system
  • Different access levels (e.g. Sponsor, Monitor, Medical Monitor, Programmer, Data Manager, Drug Supplier, Investigator, Co-Investigator, etc.)
  • Generating printouts directly from the eCRF system
  • Fast data transfer from external sources, integration with laboratories
  • Notifications (e.g. about adverse events, about opening and closing cohorts, etc.)
  • High level of security (logical, physical and system security)
  • Real-time data backup

ePRO

electronic Patient Reported Outcome, ePRO

Our digital solutions are an alternative to paper patient diaries.

How does BIOSTAT ePRO work?

icon

Remote data capture from the patient's device

icon

The ability to collect data at the site and at home

icon

Data synchronization with eCRF.biz (EDC)

icon

Improving patient experience and reducing their burden

icon

Proactive and safe data collection

Benefits:

  • Integrated with the eCRF.biz™electronic data capture system
  • Saves time and money
  • Higher level of patient compliance with medical recommendations
  • Improving data quality
  • Software based on the web application (the ability to prepare mobile applications)
  • Compliance with 21 CFR Part 11 guidelines
  • Site visits’ reduction
  • Real-time access to patient data
  • Automatic notifications
  • A wider range of collected data

Our technological solutions:

MefFile

medfile
Comprehensive solutions for the management of a doctor's and physiotherapy office.

Functions

icon

eWuś

icon

e-Prescription

icon

e-Referrals

icon

e-Sick leave

icon

Visit card

icon

e-Patient’s file

medfile
  • Online visit booking
  • Integration: Docplanner, Google Calendar
  • Telemedicine / online consultations
  • Payment services (bills, invoices)
  • Database import/export
  • Intelligent databases (self-suggestions)
  • Mobile applications (iOS, Android)
  • SMS notifications
  • Clinic website
  • Work schedule/visit schedule
  • Modules for specialist
  • Warehouse
  • Surveys and forms

haloDoctor

halodoctor

Telemedicine platform - online consultation

Functions

icon

e-Clinic

icon

e-Consultation

icon

e-Visit

icon

e-Prescription

icon

e-Sick leave

icon

e-Consilium

icon

Patient e-account

icon

Patient e-signature

Medfile® EDM integration

Telemedicine connects professionals with patients online.
halodoctor

MedSign

medsign

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.

  • SSL encryption certificates
  • Cryptographic data protection measures
  • Designated Personal Data Inspector
  • Integration with CRM
  • Improving telemedical consultation

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.

medsign

Shortening the time for formal matters, increasing the duration of specialist consultations.

  • Creation and any configuration of forms by a doctor
  • Patient filling in the forms by himself
  • Signature for the specialist services offered

SurvGo

survgo
A platform for creating, implementing
and managing opinion and satisfaction
surveys.

Fast and intuitive electronic survey.

Functions

  • Simplicity and usability
  • CATI, CAWI, CAPI methods
  • Easy configuration
  • Surveys of patients, clients
  • Easy distribution of questionnaires (e-mail, link on the website, social media)
  • Representative national trials
  • Reports/statistics
  • Benchmarks
survgo

Badanie Opinii

badanie-opinii
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.

100.00+

panelists

150+ daily

new users

  • Rapid delivery Fast realization (24h)
  • Reliability of the tests performed
  • Low survey cost
  • Full compliance with General Data Protection Regulation, GDPR
  • Up to date database of respondents
badanie-opinii

CATI

cati
CATI, CAWI, CAPI research software.

Management, creation and implementation of online surveys and surveys from a single platform.

icon

CATI

Implementation of telephone surveys, supervising the work of remote interviewers

icon

CAWI

Reaching out to selected, even small or highly specialised groups of respondents

icon

CAPI

Comprehensive solutions for mobile devices

cati

R&D
Discount

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

ulga br

Preparation time: about 10 days
Cost: from several to over a dozen thousand zlotys

Leaders

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.

thumb

Rafał Piszczek

CEO

thumb

Dr inż. Ewa Tkocz-Piszczek

Vice-President

thumb

Edyta Klemba

Pharma Division Director

thumb

Dr Marian Płaszczyca

Head of Statistics and DM

thumb

Szymon Błąkała

Senior Developer

thumb

Dr Monika Kurpanik

Research Director

thumb

Dr Sebastian Musioł

Methodology expert

thumb

Dr Małgorzata Płaszczyca

Analyst

thumb

Bartosz Olcha

Senior Project Manager

Clients that trust us:

Contact

Edyta Klemba
Pharma Division Director