Best Practices. Customized Solutions.
As a client-oriented institute for clinical research and statistics, ClinStat offers its clients tailored solutions in almost all important therapeutic areas. Our highly qualified data managers adhere strictly to international and national quality standards from the commencement of the project until the end.
Superb data management is an important factor in clinical research. With the planning, creation, validation and documentation of the study database, we ensure that complete, correct and reliable electronic data collection is possible. To ensure integrity and validity, we implement quality assurance and quality control measures.
Our Services in Data Management
- Collaboration with all stakeholders involved in data creation/modification (implementation of third-party data)
- Creation of the Data Management Manual comprising the Data Management Plan and Data Management Report
- Client-specific database design and/or according to the recommendations of the Clinical Data Interchange Standards Consortium (CDISC)
- Creation of domains according to Study Data Tabulation Model (SDTM), which groups acquired data due to the fact that technically-related information of a definable topic area is formed as entities in domains.
- CRF design
- CRF and query management
- Full range of CRF printing and configuration possibilities
- Complete printing administration and CRF shipment and tracking
- CRF annotation, definition of data handling manual and data validation plan
- CRF tracking and secure storage of CRF originals
- Data validation including plausibility checks
- Coding of diseases, concomitant medications AEs, SAEs, and active substances according to standard nomenclature (MedDRA™,WHO Drug Dictionary™)
- Reconciliation of the data from the SAEs with data from Pharmacovigilance
- Database and data entry quality control prior to database lock
- Database close and exporting the data