Statistical Analysis and Consultancy
Statistical analysis is one of the foundations of evidence-based clinical practice, a key in conducting new clinical research and in evaluating and applying prior research. The understanding of the clinical challenges that need addressing and evaluations of the effectiveness and risks of clinical actions and strategies are all based on statistical considerations.
The OPIS team has experience in all phases of clinical development, across a wide range of therapeutic areas and apply innovative approaches to study design and statistical methodology to increase the chances of a successful trial.
- Biostatistical support throughout project’s lifecycle
- Support for protocol development, study design and sample size estimation
- Expertise on statistical methodology
- Randomization services, including IWRS/IVRS
- Blinding/unblinding management, including production of emergency unblinding envelopes.
- Statistical analysis plan, including output shells
- Statistical programming using SAS®
- Statistical analyses; tables/listings/figures for clinical study reports (CSRs)
- Statistical results interpretation and presentation
- SDTM and ADaM dataset preparation and validation (submission ready dataset packages)
- Adaptive designs and Interim Analyses for early decision making
- Support for:
- Steering Committees and Data Monitoring Committees
- Regulatory submissions
- CSR and publications