AirTel e-CRFs are planned and realized to fully comply with all GCP, FDA and EMEA requirements for Phase 2-4 Clinical Studies.
AirTel e-CRFs can also be used for observational or epidemiologic studies, where full GCP compliance (while not being an absolute must) further improves data quality, thus adding value to the final clinical results.
Auditing is welcome; Internal SOPs, and all validation documents are at Auditors' full disposal.








AirTel e-CRFs guarantee 100% data traceability.
No data modification can be performed without leaving multiple traces in data records; this means that spot-on information on who made the change, why and when, is always available in the database and the history of each single piece of data can be easily and rapidly accessed.
A queries-generator and tracking system make it easy for the CRA or for the Study Monitor to quickly contact the Investigator responsible for the data and to obtain a correction/confirmation form.







In the past we were required to specify the number of edit-checks implemented in our e-CRFs.
Recently, it has become clear that every single piece of data that is going to be inserted into a Clinical Database should be thoroughly checked, mainly for security reasons.
An internal coherent management system for biochemical data (i.e. ability to convert data from a Unit to another) allows all Centers to insert data as they come from the local laboratories, and make it possible to analize all biochemical numbers in real time.
All obviously inconsistent data are automatically denied access to the database thanks to a plausibility table: only the numerical data that match the table are accepted, while other values are rejected along with a warning and the indication of the acceptable range of values for that unit.