Clinical Trial Software

  • check Clinical Trials
  • check Patient Medical Records
  • check Investigator Initiated Studies
  • check Observational studies
Compliant with FDA - Title 21 CFR Part 11
See functions
Active studies
We help you in development of "smart" eCRFs
and moving of your clinical trials into a digital world.

We offer a unique for the market multi-module electronic data capture (EDC) system - called, created for the scientific needs of the pharmaceutical and biotechnological industry. In designing it, we followed the FDA guidelines, resulting in compliance with Title 21 CFR Part 11 of the Code of Federal Regulations.

Friendly technology of electronic data capture (ECD) system - eCRF.bizTM, inspired
by Investigators, created for Professionals by Biostat Professionals.

The clinical data management system - eCRF.bizTM will allow you to easily and securely collect data, while a friendly interface will be appreciated by your Investigators. The eCRF.bizTM is an integrated research platform that completely eliminates need for paper clinical observational questionnaires, and lets us comprehensively manage entire studies. Electronic Case Report Forms (eCRFs) allow to obtain results much faster, and consequently allow for immediate review and analysis of data at each stage of the study.

Our clinical trial software - eCRF.bizTM system is used by a wide range of professionals and research centers, whose comments and suggestions provide valuable tips during constant development resulting in continuous improvement. By consulting with our customers, we can design and implement the best possible solutions for specific monocenter or multicenter studies, tailored specifically to your needs and suggestions from your recognized partners.

Use our system in following commercial and non-commercial studies:

Drug clinical trials

Medical device clinical trials

Cosmetic and dermocosmetic clinical trials

Bioequivalence studies

Investigator Initiated Studies

Our highly-qualified team have experience in development eCRF in the therapeutic areas like oncology, cardiology, alergology, dermatology, gastroenterology, psychiatry, ophtamology, neurology, etc.

All the time we are ready for new challenges.

Practical applications
Medical records

  • Collection of valuable epidemiological data – desirable from a scientific point of view
  • Data processing guaranteed to be compliant with the requirements of the Polish law
  • Increase in the efficiency of doctor's work
Observational studies

  • Single and multicenter studies
  • Non-interventional research that gathers scientific data and provides answers to research questions
  • Conducted in accordance with the principles of Evidence Based Medicine (EBM)
Clinical trials

  • Phase I-IV
  • Design and implementation of the study
  • Randomization, data management, monitoring and analysis
  • Statistical and epidemiological studies
  • Compliance with standard operating procedures (SOPs) and Good Clinical Practice (GCP)
Patient observation journal

  • Simple and useful tool in the hands of a doctor verifying compliance
  • Help in daily monitoring of various parameters in patients with chronic diseases
  • Registration of taken medication and the accompanying symptoms of illness or other lifestyle factors
  • Constant monitoring of patient's health
Market research

  • Create a new vision of the product/advertising/packaging, and a new communication concept
  • Reposition existing products
  • Provide knowledge and insight to enhance brand and product recognition
Advantages of BioStat electronic data capture (EDC) system - eCRF.bizTM.
  • Constant availability of your data 24/7
  • Faster and more efficient than paper CRF
  • Audit trial - full history of user activities in eCRF
  • Data queries management
  • Comments module - useful tool during eCRF development phase- each person involved in process can give tips directly within eCRF system
  • Randomisation and drug management module
  • Notifications/automated alerts (adverse event alerts, patient's status alerts (screened / randomized), kohorts opening and closing, e-mail alerts, etc.)
  • Customizable eCRF design
  • Online contracts signing between two parties
  • Access for everyone interested (e.g. Sponsor, Monitors, Medical Monitors, eCRF programmers, Data Manager, Investigated Medicinal Product suppliers, Investigators, etc.)
  • Dynamic reports (e.g. overall study progress, recruitment status, query report, adverse event listing, page/question verification report, etc.)
  • Printouts generation
  • Rapid transfer of data from external sources, lab integration
  • High security and data backup
  • Ongoing payment monitoring
  • Your new ideas....and our flexibility in creating new solutions
Short overview of BioStat service.
  • Preparation of eCRF validation documentation - Data Validation Plan, Validation Certificate, Data Validation Report, Data Validation Specification, etc.
  • Electronic Case Report Forms (eCRF) and eCRF completion quidelines for Investigator, Monitor, Annotated CRF, etc.
  • Randomization and Trial Supply Management - Interactive Web Response System (IWRS) , Interactive voice response system (IVRS)
  • User Acceptance Testing (UAT) - all system components are tested
  • Electronic patient reported outcome (ePRO) also commonly called Electronic patient dictionary
  • Central and local lab integration and data transfer from external devices
  • Data Management
  • Supervision of Adverse Events Reporting and Reconciliation
  • Preparing of well designed and clear landing page for your study (dedicated and prefered key visual)
  • eCRF trainings for Investigators (onsite and online)
  • Medical coding (based on MedDRA dictionary)
  • Statistical analysis and final statistical report
  • Phone and e-mail helpdesk
electronic Case Report Form (eCRF) development step by step.
  • Designing the research – tool consultations and statistical analysis planning
  • Preparation of the electronic form – test and production versions
  • Randomization
  • Signing contracts with participants of the study
  • Training the researchers
  • Data monitoring and management
  • Interim analyses
  • Closing the database and preparing it for the analysis process
  • Data analysis according to the statistical analysis plan (SAP)
  • Financial settlements with researchers
  • Preparation of the final report
Full clinical data management service for clinical trials and non-interventional studies.
  • Electronic Case Report Form (eCRF) development
  • Database structure design and development in accordance with CDASH standard
  • Ongoing data quality control, ensuring consistency and compliance with formal requirements
  • User account management
  • Edit checks Programming and Testing
  • Identification of missing data or incorrect values
  • Documentation - Data Management Plan, Data Quality Review Plan, Test Cases, Data Transfer Plan, etc.
  • Query management
  • Collaboration with international teams, ongoing communication with Sponsors, Monitors, Invastigators
  • Database cleaning
  • Database Lock
  • Training and consulting
Study success depends on excellence developed electronic case report form (eCRF) and data management service.
Choose the best electronic data capture system (EDC).
See functions
Real-time statisctics

Real-time statistics
Data queries

Data queries
Data validation

Data validation
Audit trail

Audit trail
Invitation and reminder sending

Invitation and reminder sending
Data Digital Transformation Monitoring in eCRF
Functions of electronic data capture (EDC) system.
Automatic reports
Online contracts
Audit trail
Data query
MedDRA dictionary
Protocol deviation log
Let us help you to create and manage your study in a rapid, traceable and efficient manner. Start your work with a powerful clinical data management system (eCRF.bizTM) and join the ranks our satisfied clients.
Contact us


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eCRF functions

Frequently asked questions.

Is a license necessary to purchase your eCRF system?
No. As Biostat® is the author and owner of the software, a separate/external license purchase is not required. We typically sell the eCRF system under a study implementation service model using our own system. If a client is interested in purchasing a license for our system, we approach the pricing and sale of the eCRF service individually based on that business model.
What is the lead time for setting up the™ system for an observational study?
The waiting time for creating a configured™ system tailored to a specific observational study is always adjusted to the client's expectations. However, the average time ranges from 21 days to 1 month.
Does the™ system allow for report generation?
The™ system has been enhanced with reporting functionality based on the open-source statistical package R. Integrating this software with™ enriches the conducted studies with automatically generated reports of varying complexity levels. Reports can be in the form of PDF files or web pages and can include tables, charts, and updates on study progress.
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