The Algorithme Pharma team has extensive data management expertise. The quality and integrity of clinical data being entered into our database is a key priority for us.
Our Quality Assurance Process includes Data Managers who run ongoing quality control checks and work closely with clinical staff to resolve discrepancies between the database and Case Report Forms (CRFs). Data clean-up activities include manual review of CRFs aided with automated data validation and computer-assisted data queries. Statistical tools (SAS® procedures) and database tools are used during data cleanup to identify trends or unusual values. An audit trail ensures full traceability and auditability of all database data.
We use the latest CDISC standards for acquisition, exchange and submission of clinical data. Ensuring flexibility we can work either with paper-based CRFs using the Clintrial™ software or with a sponsor’s provided electronic CRF (eCRF).
The strict implementation of well-defined standard operating procedure (SOP) assures comprehensive and accurate studies conducted in accordance with international regulatory requirements. Key aspects of our data management services include:
- Detailed data management planning
- Medical coding (MedDRA, WHO Drug Dictionary Enhanced)
- Double independent data entry and comprehensive validation
- Database transfer to sponsor in different formats (SAS®, etc.)