Module 12 Presentations

New Problems Emerge

• As a result of new technologies and innovations and electronic record keeping, the volume of information collected before, during and after the clinical trials continues to grow

• LARGE amounts of data, sometimes continuously •

Note: Lab data such as EEG, ECG or imaging data is not captured in an eCRF – this is imported using a different methodology and requires data reconciliation

• So, comprehensive data collection and efficient management is now becoming a priority for pharmaceutical companies and clinical research organizations (CROs)

The Organisation for Professionals in Regulatory Affairs