Database design, data entry and validation

Services for Clinical Trials

• Study design, sample size estimations and power calculations
• Data warehousing for clinical trials
• 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

Company data management services

Operative data management

We provide you with data management of single studies, including:

• CRF design and review
• Database design
• Data entry, remote data entry and electronic data capture
• Medical coding with MedDRA
• Data validation and discrepancy management

Compliance

Our data management processes and systems are continuosly successful in audits done in accordance with regulatory requirements (e.g. 21 CFR Part 11). All our studies are tailored on customer’s request.