Observational Data Management
Data Management is central to our observational clinical study services. As opposed to trials, observational studies have to collect existing data that are not specially planned to be collected. Thus the data management is a cornerstone of te quality of the study.
Ou data extraction and management tool, as well as our data clarification processes adapted to observational research make these services unique in industry.
Data is delivered rapidly, with quality assurance ensured by validation and verification procedures at every step of the process. LA-SER CORE becomes an extension of your team from database creation to database lock.
Data Management Services:
- LA-SER CORE data management can be utilized for clinical trials of various size and complexity, across a range of indications
- Flexibility to deliver EDC or Paper globally with on-time quality results
- Electronic Data Capture (EDC) – LA-SER CORE has worked with a variety of EDC platforms and vendors over the years, and has acquired the ability and knowledge to provide the right EDC solution that meets client specific study needs.
- Global Standards & Services
- Development of paper CRF/eCRF
- Double-key data entry (paper CRF)
- Deliverable clinical database is developed using CDISC SDTM standard
- Data definitions are provided in accordance with CDISC CRT-DD specification
- UAT in EDC systems
- Data validation
- Query generation & resolution
- SAE reconciliation
- WHO Drug Dictionary
- Clinical database transfers (interim, final)
For more details on our Data Management service area, please contact us