Your clinical trial success depends upon the quality and integrity of the data you collect. Avania provides customized data management systems to meet the specific needs of your study. Make better business decisions through easy access to real-time data, facilitated by our in-house data analysts. The Avania team will build customized dashboards that can be updated daily and shared throughout your clinical trial.
Biostatistics and SAS programming
Avania biostatisticians provide trial design consultation, statistical methodology recommendations, programming expertise, and the reporting accuracy necessary to deliver your trial outcomes on time. Our team’s in-depth understanding of regulatory and clinical requirements allows us to apply strict statistical and research principles for the design, execution, and analysis of your clinical trial.
Our biostatisticians work closely with your data management team to implement best practices and ensure clean, analyzable data. Together, we apply the most strategic statistical designs and analysis plans for your trial, including Bayesian, non-Bayesian, and adaptive designs. Because adaptive trials’ flexibility increases the risk of operational bias, partnering with highly capable biostatisticians to direct your statistical approach is mandatory for success, especially in view of current FDA guidance.
- Preclinical and clinical program consultation
- Sample size analysis and justification
- Statistical analysis plans (SAP) and protocol design consultation
- Study design and statistical representation at meetings with regulatory agencies
- Randomization schemes
- Data monitoring committee (DMC) or data safety monitoring board (DSMB) statistical report generation
- Generation of statistical summary tables, graphs, and reports using industry standard software for regulatory submissions, presentations, and publications
- Interim and final statistical analysis and reporting, including safety and ad hoc reporting
- CDISC and ADaM dataset submissions
- Data interpretation and contribution to medical writing deliverables