Data Management

Data Management for Successful Clinical Trials

Data management is a fundamental element of a successful trial. This step is critical to your success.

Development of data management plans, data validation plans and data entry instructions based on your specific study design.
Design of clinical database for clinical and external study data.
Providing ready-to use forms.
Providing training and 24/7 helpdesk.
Data entry and validation.
Data Coding
Efficient and compliant data management throughout the conduct of the study.
Data checks for consistency, validity and plausibility.
Creation, assignment and maintenance of user accounts.
Data extracts for further processing by the statistician.

Compliance Outputs
Consultancy and support in study design.
Advice in study planning / sample size calculation.
Development of the statistical analysis plan.
Creation and development of randomization schedules, web-based randomization.
Statistical programming with state-of-the-art software (SAS version 9.3).
Interpretation, conclusion and reporting of data from a statistical perspective.
Presentation of results (Interim Study Reports / Statistical Analysis Report).
Publication and Presentation Material

Thank you very much for delivering the QC’ed data by timeline. It is great to work with you and your team.

Thank you again for the very nice draft report.