Data Management
AlcheraBio has developed a proprietary data management system specifically for use in animal health studies. The AlcheraBio system covers all aspects of from planning through to delivery of a locked database converted to SAS data files and ensures confidentiality and security. Key elements of the system are described below:
- A detailed data management plan for each study is developed in consultation with the Sponsor and approved in writing by the Sponsor. The plan includes procedures for data entry, medical review, query generation, data filing, and QC, as well as transfer of central lab data, edit checks, QA, and transfer of the database to SAS.
- A study-specific database is designed for each study, and fields are mapped from the study case report forms to the database.
- After review by the monitoring staff, typically at the study site, data recorded on the case report forms are entered into the database at the AlcheraBio office. All data entry personnel are trained on each study protocol and the related data entry templates.
- A double data entry program which features an audit trail and query generation. Following resolution of all inconsistencies arising from the double data entry process and medical review, QA personnel perform an audit of the database against the raw data.
- The database is easily transformed to SAS files to allow for study specific descriptive statistics and tables and data listings.
- Database files are password protected to ensure confidentiality, automatically backed up each day, and stored offsite on a secure server.
Check out an interview on our Data Management system with our COO. Click here
For more detailed information on AlcheraBio’s data management system, click here.