Our biostatisticians, with biopharmaceutical roots, are adept at listening, researching and understanding assets, indications and competitive landscape to ensure all data is used to its maximum potential. You can count on our experience and proficiency to provide consistent, high-quality statistical support, including summaries and study conclusions to support your regulatory submissions and/or scientific publications.

Our integrated solutions blend programming expertise with the knowledge of protocol development, study design and sample size considerations and statistical analysis methodology. We’ll collaborate with you to determine methods for collecting, analyzing and presenting your data, while maintaining compliance with regulatory guidelines.

Our programming processes ensure the highest quality deliverable with the shortest turnaround time after database lock in the industry.

With the increasing costs of executing a clinical study, it’s critical to plan statistical analyses correctly earlier, to minimize, or even eliminate, the need to rework aspects of the original design, later. And our programming SOPs ensure the highest quality deliverables within the shortest turnaround time after database lock. 

Biostatistical Services

• Consultation on clinical trial design
• Develop of statistical analysis plans (SAP)
• Sample size/statistical power determination
• Randomization schedule specification and generation
• Data and Safety Monitoring Board (DSMB) and Clinical Events Committee (CEC) support
• Interim and final reporting
• NDA: Integrated Summary of Safety/Integrated Summary of Efficacy (ISS/ISE)
• FDA and other regulatory interactions, including Advisory Committee meetings
• Publication support and ad hoc analyses

Statistical Programming Services

• CDISC mapping
• Development of CDISC compliant ADaM datasets
• Tables, listings and figures
• Publication displays
• Patient profiles
• Ad hoc requests