Data Management

Data Management

Data Management is a very important part of clinical trials. Generally it is under evaluated as there is no visible impact on the outcome. But weakness of data management leads to weakness of analysis and reporting. There are several steps of data management. Basically paper and electronic CRF (case report case) collection can be considered as different approaches.  See the details below. Data Management has its own standard activiteis independetly of data collection. It’s very impoartant that the data integratity should be sustained. The data cleaning process should be also supported.

Paper CRF

While eCRF has unquestionable advantages, paper based CRFs still have relevance especially in studies of subject number < 100. Manual data entry is more cost effective in this scenario. There are only few companies left today who provide manual data entry. Planimeter is still one of them.

Even if we are talking manual data entry, it is supported internally with out eCRF system, see more details on the right side.

Data management is not restricted to data entry or data collection. Query management – which is almost completely automated in case of eCRF – is also an integrant part of data management activities. When data database is almost clean, coding according to different internal coding standards should be performed. 

Data is to be analysed. To do that the quantity and quality of protocol violations should be classified to set the analysis database flags. Finally everything should be documented, communinated with the Sponsor and filed according to the sector standards. 

 

Electronic Case Report Form (eCRF/EDC)

We started to develop our first eCRF system 15 years ago. Since then the solution has became a fully CRF 11 Part 21 compliant, widely knonwn and acknowledged web based application.

Some features:

  • Integration of a new study is extremely fast as we generate the CRFs with the help of an eCRF generation motor
  • Strict process control: data are not only collected and stored but the processes are also managed with the help of automated notifications
  • Easy connection to external data sources
  • Pre-build integration with R or R/Shiny making any calculation easy or setting up a flexible dashboard
  • Online systems have to face with many threads. Several certificates prove that we are continuously working on the improvement of the safety and data privacy.