The quality of submission data is of paramount importance. Over time and many study preparations, EDETEK has accumulated a large base of domain specific knowledge, industry best practices, and validation checks. In order to maximize the effectiveness of quality assurance measures, EDETEK has developed a controlled system that measures and monitors data quality metrics. The results can be easily accessible to all relevant parties. Such implementation ensures that data issues are discovered early and the effectiveness of fixes can be tracked. The end result is high quality deliverable, with reduced time/cost, and less efforts of manual investigation.
- Compliance Validation
- Includes all of the most updated FDA checks (105) as well as Janus repository (4) checks (assurance of approval to deposit into Janus repository)
- Output will be in Adobe® Acrobat®PDF, Microsoft® Excel, XML formats
- Data Consistency and Coherence Validation
- EDE-CHECKTM has accumulated a vast pool of domain knowledge throughout years of hands-on study submission experience. As a result, EDE-CHECKTM has included over 500 additional rules to validate the data consistency and coherences throughout an individual study or a series of studies. This service also focuses on the mapping consistency of a series of studies. These rules can be reported in the same format as the FDA checks with the identical level of severity.
- Expert Review
- For studies of different therapeutic areas, EDETEK construct customized rules to check for data that is relevant to the specific therapeutic area. Our clients can be presented a thorough data quality check that would be otherwise incomplete if using only generic checks.