Biostatistics - read more
All services required in the lifecycle of clinical development projects, beginning with biostatistical consulting during development of the project concept up to contributions for submissions or HTA dossiers and post approval studies
AMS Services include:
- Biostatistical consulting and writing for clinical trials and observational research studies
- Sample size calculations
- Randomization (with optional integration of the randomization list into the eCRF)
- Biostatistical review of key documents
- Support of / Participation in Monitoring Committees
- Comprehensive and detailed statistical analysis plans (SAP)
- Review and contributions to study reports/posters/manuscripts
- SAS Programming for the analysis, review listings, periodic safety reports or trial results reporting to EudraCT database and implementation of CDISC SDTM / ADaM standards.
- Health Economics, Patient surveys, Interim analysis, Adaptive designs, Burden of Disease studies, cost-effectiveness analyses, quality of life evaluation
- Continuous training on all applicable guidelines is part of our Quality Management System.
All services are performed on validated systems (SAS, NQuery, Pinnacle 21 Community Validator) following all applicable guidelines (e.g. GCP, ICH E3/E9, 21 CFR part 11).
The aim of clinical research is to gather data and to derive information from it. Use AMS experience and training to your benefit to help you select the optimal study design and appropriate endpoints for the objectives of the project, and by providing time- and cost-efficient conduct of all services with high quality deliverables.
Within a project, the Biostatisticians provide ongoing support/consulting and status reports to the Sponsor and project team and cooperate closely with Sponsor scientists, project managers, data managers, medical monitors to provide the optimal solution for your needs.