As a client-oriented institute for clinical research and statistics, ClinStat offers our clients tailored solutions in nearly all important therapeutic areas. Our highly qualified data managers adhere strictly to international and national quality standards from the beginning 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 cover:
• Highly experienced, competent employees
• Close collaboration with all involved
• Creation of the Data Management Manual comprised from 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):
• Application of the 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.
• Use of the data standard, Analysis Data Model (ADaM), which is a model for analysis data and its metadata. In the process, the data structures become so specified that a statistical analysis is possible without further data transformation steps
• 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
• Application of established database systems (e.g. Oracle, MySQL)
• Data validation including plausibility checks
• Coding of diseases, concomitant medications AEs, SAEs, and active substances according to standard nomenclature (ICD, INN, MedDRA™, ATC, WHODrug™, COSTART)
• Reconciliation of the data from the SAEs with data from Pharmacovigilance
• Compliance with the ICH-GCP Guidelines and other national and international standards and regulations
• Database and data entry quality control prior to database lock