Development of study databases

Both software solutions we use, secuTrial® and REDCap®, have been validated by us and guarantee Good Clinical Practice (GCP)-compliant and secure data management.

We advise you on which tool is the best solution for your project and ensure that your study database corresponds exactly to your study protocol. Our software solutions offer as system-integrated functions: Randomisation and stratification, blinding and emergency unblinding, data import and generation of reports.

With REDCap^®, you can also develop a study database yourself. You will receive free access and start-up assistance from us.

Data management plan and protocol sections

If your study bank is developed by us, we will create a corresponding Data Management Plan and write the data management sections for your study protocol if you wish.

Training

If required, we will introduce your study team to the use of the study database and train the staff at the participating study centers.

Support throughout the entire duration

We guarantee the technical maintenance of your study database and take care of any adjustments. In addition, we take care of the administration of user accounts.

Data export and archiving

We carry out data exports on request. After completion of the study, we create a final export of all data. Your study database will then be properly stored for long-term archiving.