Presentation

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.

Pharmaceutical
companies

Biotechnological
companies

Clinical Research
Organization (CRO)

Academic & scientific-educational units

Medical universities

Hospitals, clinics

Scientific societies
and associations

Medical equipment
manufacturers

Individual clients (scientists, KOLs, etc.)

Therapeutic areas

Projects implemented in various fields:

Oncology
Gastroenterology
Transplantology
Cardiology
Neurology
Allergology
Psychiatry
Neonatology
Diabetology

Pulmonology
Immunology
Andrology
Proctology
Dermatology
Ophthalmology
Rheumatology
Virology
Hematology

What we do?

Comprehensive services:

Clinical trials

Non-interventional studies

Medical statistics

Data Management

eCRF.biz™ system

Market research
and public
opinion surveys

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

Patient’s medical 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:

R

SPSS

Python

Basic descriptive statistics

Verification of statistical hypotheses

Interdependence analysis

Multidimensional analyses

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).

Configuration, validation, cleaning and database blocking

Database testing, UAT

Development/update/ validation of eCRF

Database Management

Ongoing quality control

User account management

Documentation

Queries management

Reconciliations

Edit checks

Formal and statistical verification

Identification of outliers

Data management services on external EDC systems

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.

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

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?

Remote data capture from the patient's device

The ability to collect data at the site and at home

Data synchronization with eCRF.biz (EDC)

Improving patient experience and reducing their burden

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:

eCRF – electonic data capture system in clinical trials

Electronic Medical Records System

Online platform for medical consultation

Authorized service to collect approvals and create forms

Application for surveying clients

Consumer Panel for Surveys

Research software: CATI, CAWI, CAPI

Comprehensive software for veterinary offices

MefFile

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

Functions

eWuś

e-Prescription

e-Referrals

e-Sick leave

Visit card

e-Patient’s file

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

Telemedicine platform - online consultation

Functions

e-Clinic

e-Consultation

e-Visit

e-Prescription

e-Sick leave

e-Consilium

Patient e-account

Patient e-signature

Medfile® EDM integration

Telemedicine connects professionals with patients online.

MedSign

Authorized 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.

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

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

Comprehensive software
for veterinary offices

Weterynaryjna Elektroniczna Dokumentacja Medyczna

Veterinary Electronic Medical records

Office management in one place.

Karta wizyty z wizualizacją dolegliwości

Visit card with visualization
ailments

Oszczędność czasu umawianie wizyt online.

Save time making an appointment
online visits.

Intuicyjny interfejs, szybkie i proste zarządzanie gabinetem.

Intuitive interface, fast
and simple office management.

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

CATI

CATI, CAWI, CAPI research software.

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

CATI

Implementation of telephone surveys, supervising the work of remote interviewers

CAWI

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

CAPI

Comprehensive solutions for mobile devices

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

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.