Clinical trials rely on numerous sources of information, the processing of which must be controlled.
Although largely paperless, clinical trial data collection systems do not yet connect to comprehensive medical patient folders. Thus the clinical and biological data of the clincal trial are transcribed manually in electronic observation notebooks (eCRF). The re-entry of these data representing, depending on the trial protocol and the content of the source patient medical folder, 13 to 75% of the clinical trial data, today mobilizes many resources and is a source of avoidable errors.
1. Integration into the control plan
Our solution supports and reinforces the control plan defined by the clinical research associates by controlling the consistency between the external data sources and the entries in the EDC or CDMS. Together we define a scope of application as well as a list of entities to be controlled and consistency checks based on the analysis of medical language.
2. With the ability to analyze 100% of medial CRFs and clinical notes from patients folders
The language analysis technologies that we develop allow us to analyze thousands of reports in bulk and identify inconsistencies between different databases / sources. The precision achieved varies according to the entities to be extracted, it is generally the order of 85% to 95% which reduces the cost of controls because the anomalies detected will generally be correct
3. Investigations can be supported by our PraxyConsultation tool
In the event of a call from patients to carry out investigations, our PraxyConsultation solution for interview summary and structured data extraction can also be used to save time and be more precise. See ProxyConsultation . These data are of course reviewed and validated by the investigator
HDS SaaS or on premise solution
Pay-as-you-go
depending on the number of errors detected and the accuracy of error detection
Accuracy gain
Gain of precision for clinical research associates: PraxyData makes it possible to check 100% of case reports and Medical Reports
Scalability and speed
The solution is quickly deployed to control thousands of files