Modern eCRF research system

Application dedicated to research projects

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We offer a unique for the polish market multi-module system called eCRF.biz.plTM, created for the scientific needs of the pharmaceutical industry. In designing it, we followed the FDA guidelines, resulting in compliance with Title 21 CFR Part 11 of the Code of Federal Regulations.

The eCRF system will allow you to easily and securely collect data, and the friendly interface will be appreciated by your researchers. eCRF.biz.plTM is an integrated research platform that completely elimininates paper clinical observation questionnaires, and lets us comprehensively manage entire research projects. Electronic CRF's allow for much faster obtaining of results, and consequently, for immediate analysis of data at each stage of the study. Our eCRF.biz.pl™ system is used by a wide range of professionals and research centers, whose comments and suggestions provide valuable tips in the process of the system's constant development and continuous improvement. By consulting with our customers, we can design and implement the best possible solutions for specific single or multi-center studies, tailored specifically to your needs and suggestions from your recognized partners.

Aktywne badania
Meet the ecrf.bizTM system
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
Safety and other advantages
Intrusion Blocking Systems Intuitive IT Support Web application eCRF Data query Randomization Registration of doctors Title 21 CFR Part 11 Compliance Data validation Registration of doctors Payment monitoring Audit trail Weryfikacja danych Encrypted connection Vials Undesirable events Notificaitons Statisticians' support Physical security of the servers Variety of access levels Statistics Data backup User friendly Remote access Templates of forms Correctness validation Statistics monitoring User tracking Kopie zapasowe Multiple access points History of activity Responsiveness Required authentication Customizable design Secure database Antivirus systems Automated error control system Printouts generation Ease of use Changes possible during the study Multilevel firewalls Statistical analysis plans Medical software Electronic Data Capture System
Invitation and reminder sending
Audit trail
Real-time statistics
Data queries
Data validation
Stages of the research process:
Preparation
Designing the research – tool consultations and statistical analysis planning
Preparation of the electronic form – test and production versions
Randomization
Implementation
Signing contracts with participants of the study
Training the researchers
Data monitoring and management
Interim analyses
Conclusion
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
Data management
Two-step data validation
Sending invitations and reminders
Data preview
Databases
Creating the reports
Examples of modules
Hint module
Statistics module
Media Management Module
Research Aids
Files
Undesirable events
Audit trail
Data backup
Data queries
Implementations
Medical University of Silesia
Polish Financial Supervision Authority
Medical University of Warsaw
Psychosocial Risk Scale
01
Data management
Two-step data validation
Sending invitations and reminders
Data preview
Databases
Creating the reports
02
Examples of modules
Hint module
Statistics module
Media Management Module
03
Research Aids
Files
Undesirable events
Audit trail
Data backup
Data queries
04
Implementations
Medical University of Silesia
Polish Financial Supervision Authority
Medical University of Warsaw
Psychosocial Risk Scale

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eCRF functions
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