Data management

in clinical trials and observational studies.

Effective Data Management is a key source of study success.
We have built our data management center within the organization that supports all clinical studies based on the Biostat® EDC software - eCRF.bizTM. With experienced Data Managers on board we can handle every clinical trial to a successful completion.
We base our work on international standards (Good Clinical Data Management Practices, Version 4, October 2005, Society for Clinical Data Management) thus providing our clients with high quality services in this field.
For us data management is something more than just a process
of managing data.
We accompany Sponsors in management, but we also share our knowledge in the wide area of clinical data management by introducing them to the basic activities and documentation in the area of data management.

The balance between the amount of collected data and its quality is extremely important. A clear definition of the study objectives influences eCRF development as well as a manner of presentation and statistical analysis of collected data.
Data management
Design the study with us properly to significantly reduce the time devoted to activities related to Data Management and data analysis.
Take advantage of professional consulting, which provides expert support indicating the direction of development, systematizing activities and eliminating weak points.

Our advantage is the team open to cooperation in clinical trials based on various EDC technologies.
Biostat® scope of Data Management:
Rozwój eCRF
  • eCRF development
  • Database setup and validation
  • Database administration
  • Comprehensive quality control
  • User account management
  • Edit checks
  • Documentation: Data Management Plan (DMP), Data Validation Plan (DVP), Validation Certificate, etc.
Data queries
  • Query management
  • Data entry and data validation
  • Database testing, UAT
  • Data cleaning and database lock
  • Reconciliation
  • Database delivered in SAS, XML, or other formats
  • eCRF tracking, reviewing, validation, and updating
  • Trainings and consulting
  • Cooperation with international study teams
  • Data Management services on different EDCs
Other eCRF system functions.
Automatic reports
Online contracts
Protocol deviation log
Audit trail
Data query
MedDRA dictionary

Frequently asked questions.

What platform does Biostat® use for Data Management?
We utilize our in-house EDC software,™, supported by our dedicated data management center.
Why is the balance between the amount of collected data and its quality important?
A clear definition of study objectives directly influences eCRF development, the way data is presented, and how it's statistically analyzed. Proper data balance ensures efficiency and accuracy.
How can designing a study with Biostat® benefit me?
Designing your study with us can significantly reduce the time devoted to Data Management and data analysis. We offer professional consulting, systematizing activities, and help in eliminating weak points.
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