Coltrials offers to design data registration forms (CRF), which comply with FDA requirements (21CFR part 11). We train the centers and investigators prior to data entry in the CRF and provide ongoing support during the development of the study.
The development of the forms to be filled out in the study and the training to the centers and investigators before the data entry in the CRF.
Compliance with ALCOA CCEA principles in the CRF.
Permanent during the development of the trial.