
Data Management
Since 1987, our high level of attention to detail combined with our well-developed processes and common-sense approach, have earned Datapharm Australia a strong reputation for providing excellence in data management. We can meet all your data management needs and are able to tailor our services to meet your budget.
Our data entry personnel are highly experienced in handling medical and scientific data. All data is thoroughly reviewed by appropriately trained and expienced staff to ensure data integrity.
All our data management processes are regulated according to closely controlled SOPs and in accordance with ICH GCP and FDA 21 CFR Part 11. These established systems can offer you significant time and cost savings.
Our data management services include:
- Case report form (CRF) design, either paper based or electronic
- Data entry – double data entry if required
- Database design and implementation
- Data validation and cleaning
- Tracking reports
- Data listings
- Coding of adverse events and medical history in the latest version of MedDRA by Certified MedDRA Coders
- Coding of medications in WHODD
