- CRF design.
- Database definition and creation (with or without CDISC)
- Data collection :
• eCRFs are developed using a full-web secured software, ENNOV CLINICAL, with controls at all steps and providing adaptability for all types of study to fit Customer needs. DELTA CONSULTANTS provides Customers with user friendly and secure data capture.
• Traditional paper CRFs.
• Patient Reported Outcome (ePRO).
- Data cleaning plan writing.
- Database cleaning.
- Tracking of corrections with audit trail.
- Integration of external data.
- Coding of medical terms and drugs with existing dictionaries (MedDRA, WHO Drug etc.).
- Reconciliation of Serious Adverse Events with the pharmacovigilance database.
- Data review meeting and report.
- Database quality control.
- Data-management report and regular progress reports.
- Database lock and transfer.
- To meet regulatory requirements, only the software recognized by the competent authorities is employed.
- Consulting: DELTA CONSULTANTS also offers a consultancy service providing critical review of documents such as data-management and validation plans, database audits and medical term and drug coding validation by the medical director.
As a key step in the conduct of a quality study, data-management necessitates rigor and experience. Whatever the chosen support, paper CRF or electronic CRF (eCRF), DELTA CONSULTANTS provides all the necessary tools and services for optimal and secure management of study data.