Data management and warehousing

Services for Clinical Trials

• Study design, sample size estimations and power calculations
• Database design, data entry and validation
• Statistical analysis and reporting
• Medical writing
• Clinical trials information systems

Related services

• Toxicity and safety models
• Regulatory guidance and consulting
• Biomarker discovery and validation
• Pre-clinical pharmacokinetics
• In vivo disease models

Data management

We provide our customers with a comprehensive set of services in data management

• Study planning
• Protocol review
• CRF design, review and printing
• Planning and review of data management activities
• Data management plan, database design, annotated CRFs and data validation plan
• Study conduct
• Database setup and testing
• Pre-entry review and tracking of CRFs
• (Double) data entry, remote data entry and electronic data capture
• Data transfer of external data
• Data entry verification, data validation and discrepancy management
• AE/SAE reconciliation
• Medical term coding (e.g. MedDRA and ATC)
• Database quality control and database lock
• GCP documentation and review of the above activities
• Customized status reporting capabilities (e.g. study portal), including information about database and CRF/query flow

Data warehousing

We provide our customers with data transfers from other service providers to one central location at SBW/4Pharma, integration of data across several studies, data analysis or mining from the data warehouse, maintenance of data warehouses, and electronic submissions.

Common Technical Document

We provide our customers with common technical document services to perform integrated statistical analysis across studies, and to incorporate all the required documents and data into the electronic submissions.

All our studies are tailored on customer’s request. For more information, contact us from this link.