Where all data pieces come together in the form of a clear and concise report.
As clinical information specialists, we understand that all relevant trial data needs to be properly analyzed, interpreted, and displayed. Our expert medical writers will work with you to fast-track your trial process to the final CSR.
The process is streamlined when working with data generated by our Oomnia® EDC/CTMS and statistically analyzed by our team of biostatisticians. This level of integration results in seamless information flow between our team members and an unprecedented level of efficiency.
During such a process, our medical writers have constant access to the eCRF and EDC documents, the team of biostatisticians, and the statistical analyses, ensuring that the resulting Statistical Analysis Plan and Statistical Analysis Report are written precisely and efficiently.
- Statistical and data management contributions to study protocols
- eCRF Validation Report
- Clinical Data Management Plan
- Data transfer plans
- The Statistical Analysis Plan (SAP), which is prepared in accordance with the industry best practice guidelines
- Interim analysis reports
- PK/PD data analysis report
- The final Statistical Analysis Report (SAR), which is written in accordance with ICH E3 guidelines and includes full patient listings and the annotated eCRF(s)