Electronic Case Report FormeCRF
When we started in 1997, everybody ran paper based clinical trials. The concept of electronic data capture was determined and Planimeter was among the first companies to provide an electronic way for data collection.
Our solution has been successfully implemented in more than 10 countries during the last five years and it turned out to be a valuable solution for data collection in clinical trials.
FDA (Food and Drug Administration) also let out a check list to adjudge the 21 CFR Part 11 compliance of a system and I can declare that our solutions fulfils that requirement, too.
Our eCRF fully represents the Investigator’s expectation to work in a self-evidently simple system without unrealistic checks and application. When we developed this system we were absolutely aware of documentation demands of a clinical trial. This concept was fully integrated into this system and this solution leads to a 98% satisfaction with respect of system usage.
But we are a statistical team and we were quite aware of clinical trials when we started to develop our solution for data collection. The system was tested so far in 27 studies and 14 countries and all feedback emphasised the simplicity of the system. We are not surprised to hear that but we are proud of that.
The eCRF can cover all the usual required activities:
- Query management
- (S)AE reporting
- Derivation of printed versions for archiving purposes.