EDC and Paper Based Data Entry for Clinical Trials

QA Data offers a flexible data entry service handling both paper based to Electronic Data Capture (EDC) via online web-based Electronic Data Collection or the new innovative Digital pen technology. Our advanced EDC features help streamline the entire process for small phase 1 to large-scale Post Marketing Surveillance studies.

QA Data is compliant with all aspects of CFR Part 11 and uses software specifically designed for clinical trials, starting from study design leading all the way to collection, management and reporting of clinical trial data.

Our experienced team of Data Managers manage the entire Data Management process and continually keep clients informed via study update reports. We also offer continuous support via our support desk which is operated by our IT department who also maintain and host our systems.

The EDC application unifies the functionality of paper data entry with EDC providing a single electronic clinical data management platform. This exceptional hybrid capability enables you to choose the best methodology for each site, it allows you to include sites using paper CRFs and supports existing paper processes.

QA Data’s EDC system enables the study sites the ability to enter and manage their own CRFs, run reports and view study documents via a web style interface.

EDC Software Features:
• Easy installation with minimal site set-up configuration
• User-friendly system designed to resemble windows toolbars making it familiar and straightforward to manage entry and cleaning of data
• Patient Search function links to the actual study data (PDF format), with the option print or download
• Prior to initial patient entry a test database will open to allow sites time to familiarise themselves with the system
• An audit trail is available that is printed or saved for archiving in study files
• Document sharing between site and sponsor
• Data query tracking for both site & sponsor review

QA Data guarantees your data will be captured and validated in compliance with the highest industry standards, namely Annex 11, FDA guidelines and ICH.

For more information or to discuss EDC and paper based data entry for clinical trials please contact us directly.