Observational research and clinical trials

eCRF.bizTM biostatistics and data analysis centre concerns itself with data processing from various commercial and non-commercial research projects, including clinical, observational and educational ones. We also offer support and consulting in research carried out by academic centres.

We offer you an electronic research system dedicated to medical research. eCRF.bizTM is modern software designed by BioStat® company that has over 14 years of experience in medicine and pharmacy research market.

We provide our clients with organisational support in:

Analysis and observational research
Analysis and clinical trials for stages I-IV
Analysis and statistical research
Analysis and epidemiological studies

Thanks to the eCRF.bizTM platform our clients’ data are safe at any stage of the project – from entering through processing to statistical analysis. The main aspect of the registers offered is the fact that they allow to conduct any research in an electronic form.

Clinical trials for stages I-IV

Within observational research we may offer:

The design

  • Statistical analysis protocol
  • Sample size
  • Selection of randomisation method
  • Selection of statistical analysis method

Collecting data

  • eCRF.bizTM Research project system
  • Monitoring and data administration
  • Preparing the data to statistical analysis

Statistical analyses

  • Reports and transition analyses
  • analyses of relations, bioequivalence
  • Comparative analyses
  • Analysis of lifespan and quality of patients’ lives
  • Exploring diagnostic rules

Observational research

In observational research the effects of treatment are assessed paying special attention to possible occurrence of adverse effects. Such research is conducted after the given product enters the pharmaceutical market. Thanks to that, one can assess the effectiveness of treatment, risk factors and types of possible adverse effects. Observational research are definitely less expensive and time consuming than clinical trials.

Within observational research, we may offer:

The design

  • Sample size method selection
  • Preparing surveys, questionnaires, forms
  • Database scheme

Collecting data

  • Research implementation
  • Monitoring the data entering process
  • Database preparation

Statistical analyses

  • Statistical analyses compliant with project assumptions
  • Correlations and statistical models
  • Final results report

Our eCRF.bizTM system allows to conduct and manage observational research and clinical trials in pharmaceutical, biomedicine and clinical medicine industry. 

We guarantee safe, encrypted online access to the data as well as the data quality and completeness during their registration. Our software provides complex reporting mechanisms which allow to monitor the research progress and control the whole process planned.

ECRF advantages:

  • Statistical module which presents research results in a comprehensible form
  • Simple to use and easy to understand web application
  • Multi-access
  • Easiness in designing and testing forms
  • Control over the correctness and completeness of data entered
  • Monitoring set of records (audit trail)
  • Security (compliance with guidelines in Title 21 CRF Part 11)
  • Automatic data backup module
  • Querying mechanism (data query)
  • Team support consisting of IT and statistics experts with longterm experience in carrying out various commercial and scientific projects
  • Possibility of editing, even while the research is being conducted
  • Possibility of printing out CRF forms
  • Any actions done by system users, especially these which refer to database modifications are registered (audit trail)
  • eCRF.bizTM forces the user to enter the data correctly by automatic control over the correctness of data entered, their field and logic of forms
  • The access to particular parts of the system is limited by the level authorisation system
  • Precision, reliability, high effectiveness and possibility to monitor incorrect or changed entries
  • Connection between system and users’ workstations takes place with the use of encrypted communication protocol (HTTPS)

eCRF security:

Administration access via encrypted connections
Registration of any individual accessing the system
Protection against attacks such as SQL Injection
Physical server security system
Daily database back-up to external location
Logical security system