Optimal data management, programing and statistical analyses processes are pivotal to reducing the time and cost of drug development. The improvements that can be made by implementing the most appropriate and advanced measures available for designing, collecting, analyzing, converting, and reporting clinical research data throughout the drug development process result in an objectively higher data quality. Our biometric services provide submission-ready trial results with an assurance of scientific integrity.
From trial design to clinical trial reporting, Biostatistics play an indispensable role in the clinical development process. At Europital, we provide a modular approach adapted to the specific needs of your project. We provide experts in the biostatistics fields for trials from Phase I–IV and from providing advice on a single issue through to statistical coverage for an entire project from concept to regulatory submission and defense.
- Statistical input to protocols, including overall strategy and sample size calculation
- Preparation of the Statistical Analysis Plan (SAP)
- Adaptive design and group sequential strategies
- Innovative analyses, such as Lag-time analysis
- Interim analyses and Exploratory post-hoc analyses
- Full integration of CDISC
- Preparation of DSMB charters and analyses, and Participation in DSMBs as independent statisticians
- Participation in Regulatory Agency Meetings as the responsible statistician
- Performance of analyses and reviewing or preparing answers to Regulatory Agency questions
- Consulting, planning, preparation, and review of the Integrated summary of safety (ISS), the Integrated Summary of Efficacy (ISE), and the clinical pharmacology summary
- Post-marketing and lifecycle management activities
Rigorous and comprehensive Clinical Data Management is critical for the success of clinical trials. To ensure your trial generates high quality, scientifically valid and statistically sound data, our experienced data managers can be part of your clinical development strategy and reliably increase your trial capabilities from the planning stage, through to execution and beyond.
Europital provides well performing data management expertise and secure technology. Our data managers have a scientifically driven mindset with a view to collaborating with cross functional teams to ensure that data is collected, managed and reported accurately and so reduce the development time for new treatments.
- Clinical database design, testing, and implementation
- Development of the data management plan and data validation plan
- Case report form (CRF) design either with electronic data capture (EDC) or paper
- Medical coding
- Data entry and Data review
- SAE reconciliation and Discrepancy management
- Oversight, management, uploading and review of third-party data
- Database lock activities