- electronic case report form - Electronic Case Report Form
Clinical Trial
Modern technology
in Big Data service
The world is changing, and so are we.

We optimise the research processes by providing the best and proven solutions.
Move your research
Into a digital world
The system has been created by professionalists for professionalists in accordance with FDA Title 21 CFR Part 11 standards.

Precise data management and their completeness.

IT team, statisticians, and in-house data managers.
Clinical trials
Observational research (NIS)
PASS research
Medical registers
PMS Study
For everyone interested
Data management
Medicine suppliers
Alternative physicians
Other medical staff
Medical monitors
Dostęp dla wszystkich
Research design
- Data gathering
- Statistical analyses
Projektowanie badań
  • Statistical Analysis Plan(SAP)
  • Justification for the research realisation
  • Randomisation and sample size selection
  • Preparing CRF
  • Key Visual research
Raport końcowy
  • Creating research database
  • Preparing data for statistical analysis
  • Data Management Plan
Projektowanie badań
  • Reports and transient analysis
  • Final report elaboration
  • Graphic layout
research type and forms of access
cafeteria – widgets (drag&drop)
audit trail
data queries
rules and conditions creator
data validation - seals
randomisation, drug management
online contracts signing
remote access
data backup
Funkcje i właściwości systemu
and properties
Research types and forms of access
The research realisation requires varioues forms of access and data gathering processes:
Anonymous research
The access is given to anyone who has received a link only to the questionnaires.
One-off codes
The access is granted after providing special access code.
Individual login and passwords
Access to the questionnaire and user interface
Possibility to fill in various questionnaires based on unique e-mail address and user’s password in eCRF applications.
Access to the questionnaires is realised by „users/doctors” module.
Typy badania i formy dostepu
and properties
Cafeteria widgets (drag&drop)
Field types
  • single-choice option field (divided into groups within one question)
  • multiple-choice option (divided into groups)
  • short answer (single-line text field)
  • open questions (long, multiple-line answer)
Tworzenie formularzy (drag & drop)
and properties
Cafeteria – widgets (drag&drop)
List of choice
Informative text
Twig template
Date (date section)
Ranking list
Hidden field
E-mail verification
Meddra browser
Relation between sites
Autosuggestion field for linking selected repeatable sites with the other ones – in order to, e.g. Determin the relationship between the values in a questionnaire with adverse events.
Tworzenie formularzy (drag&drop)
and properties
Possibility of editing and making remarks to a questionnaire; the function is active only in the research design phase.
and properties
Audit trail
Every questionnaire change done by users is recorded.

Audit trail overview is possible for every question with a division into exact time and author of the change.
Audit trail
and properties
Data Query
Query processing
Monitors can add queries to every question and site in a questionnaires.
Notifying doctor/monitor about a new query
Doctors receive automatic e-mail notification about new queries for Patients.
Responses to queries
The monitor is notified once the doctor gives an answer.
Site/query seals breaking
After every patient’s data modification due to the processed query, the verification seals are broken, so the monitors have to check the modifed sites again.
Data Queries
and properties
Rules and conditions creator
Creator allows to make conditions for selected fields from the whole questionnaires.
There can be more than one condition and they can be based on various logical criteria (and/or).
Every field of the following type:
  • list of choice
  • radio
  • checkbox
  • text field
  • date field
  • ranking list
  • slider
The fields can be included in any conditions creator available in eCRF.
Kreator warunków
and properties
Data Validations - seals
Monitors have the possibility to sign every question, site and and questionnaire visits; digital signature and doctor’s approval result in special sign in the shape of a round seal.
Seals breaking
After query is added to any question, the doctor is informed about possible error occurrence in the questionnaire; he/she is given then a temporary access to edit the priorly closed site; if the change is entered to the database, then all seals for particular question, site and visits to which the change refers are broken; monitors have to check the visit history and sign the document if possible.
Multi-personal seal
All data in the system can be signed by an unlimited number of people.
Walidacje danych pieczęci
and properties
Adverse events, superior values provided in the cafeteria, or patient’s status change often require to urgently notify selected group of people or monitors.
E-mail and status (active/inactive) come under configuration, as well as the type:
  • notification sent to selected group of addressees
  • notifications sent only to the author of the changes in the questionnaire (e.g. Doctor)
  • PDF file generated from the questionnaire content – downloaded by the user while filling it up
  • a notification with a contract to sign – only to the author
and properties
Randomisation, drug management
Medicine and phials database divided into branches and groups; medicines are blinded, randomisation automatically selects the patients in given proportions; in order to assign patients to the randomisation module, one has to set up the input conditions in creator known from conditions on sites and questions.
Medicine database is an advanced forwarding mechanism which aims at medicines management from the moment of shipping from the warehouse to reaching the end-centre; audit trail of the medicine as well as all actions are recorded.
The information referring to the type of medication given to particular patients is provided to all parties in the research only in the final report and after closing the database and medicines unblinding
Randomizacja, drug management
and properties
Reports on the basis of visits and selected questions ( by using TWIG system for data generation).
Reports on the basis of SQL (administrator).
Reports on the basis of „R” environment with the use of Latex and other libraries.
Reports on the basis of the sample analysis.
and properties
Online contract signing (documentation)
Thanks to the electronically signed documents, we limit the amount of printing; it also allows to speed the contracting process up, as well as improve settling accounts with researchers and sign possible annexe – in case of research prolongation.
Positive opinion from DZP law agency.
Access Code
Registration Form
Receiving contracts on Emails
Zawieranie umów online
and properties
System security
  • encrypted connection
  • SQL Injection attack protection
  • verification of anydata transmitted into the application
  • use of transactionsin order to keep data integrity
  • registering users requesting for the access to the system
  • access only for authorized users.
  • the access is grantedonly to users directly related to the projects realised by eCRF
and properties
Physical server security
  • limited access to devices and servers
  • every server roomis connected to two independent internet and electrical connections
  • data backup is processed in real-time
  • switching to a spareserver is processed immediately by IP Failover
Bezpieczeństwo - data backup
and properties
Logical security
  • multilevel firewall systems, detection and active intruders blockingsystem (IDS/IPS), logicalnetwork division (VLAN)
  • antivirus systems
  • every user hasa uniqueID and password
  • unauthorizedlogin attempts are registered
  • ongoingmonitoring and software updates
Bezpieczeństwo - data security
and properties
Remote access
You can enter the system from any place via Internet web browser.
Zdalny dostęp
Remote access
Data backup
Data backup is processed in realtime.
Switching to a spare server is processed immediately by IP Failover.
Tworzenie kopii zapasowych
your work from
now on
Już dziś rozpocznij pracę z potężnym systemem
Our Clients
"The level of eCRF implementation in the BioStat®0 system meets the highest European standards and can be a showcase of the possibilities of Polish companies operating in a difficult and extremely competitive field. The quality of the IT solutions provided by BioStat® outperforms most alternative eCRF systems in terms of functionality and security."
Milton Essex S.A.
"Created by BioStat® Sp. z o. o. system is transparent and easy to use. Professional technical support of the eCRF system means that any changes are introduced immediately, which does not cause interference in the course of the study. "
"BioStat® is very flexible in planning and proposing solutions, which is highly valued in the present times. I consider BioStat® to be a trustworthy and recommending service provider in which it is worth entering into cooperation."
Cour Clients
Chiesi Novartis Egis Mabion Teva Roche Lek Celon Medtronic Mundipharma Senju Takeda Uniwersytet Śląski w Katowicach WiM Medical University of Warsaw
Numerous research
- one system
gain the upper hand