Clinical data management
Our Aepodia data management team ensures this is done not only according to good clinical practice (GCP) and good clinical data management (GCDM) quality standards but also in compliance with sponsor requirements.
Activities are performed according to Aepodia data management SOPs and include:
- CRF design: eCRF or paper CRF ( and printing) and completion guidelines;
- database design, creation and administration;
- data cleaning to check programming and testing (including document edit check specifications, test plans and test reports, and query management in collaboration with the study sites;
- medical term coding (MedDRA, WHO drug);
- inclusion of external data (ECG, CT scan, MRI, lab results, drug concentration levels, PK data, etc.);
- SAE reconciliation between the safety database and the clinical database;
- ongoing reports during the study: online analyses, metrics, study status, etc.;
- database locks (interim and/or -final lock); and
- final data transfer.
Data management activities, from database development to database lock, are performed in compliance with 21 CFR Part 11 requirements and using of the Study Data Tabulation Model (SDTM) as defined by the Clinical Data Interchange Standards Consortium (CDISC).