Review and query management
We offer review and query management of clinical trial data. We can review data line listings or any other format of listings provided by the client, according to the Data Management Plan. If requested, queries can be entered directly into the EDC system.
User Acceptance Testing
User acceptance testing (UAT) of eCRF and of edit checks can be performed. We will test if the eCRF holds all required elements as described in the protocol, and if performance of the eCRF is as expected. All edit check types (e.g. electronic or manual edit checks) can be tested according to guidance provided by the client.
AE and SAE reconciliation
Adverse events, adverse drugs reactions, and serious adverse events review and reconciliation is an essential part of data management for clinical studies. We can perform this review and reconcile AEs, ADRS, and SAEs with medical history, concomitant therapy, and the clients' central SAE database.
Coding
Coding of medical terminologies (adverse events/medical history/medications) to ensure medical logic and consistency can be performed on the clients' coding system. We have experience with MedDRA and WHO dictionaries.