- Regulatory Affairs
- Clinical Operations
- Data Management
- Medical Services
- Quality Assurance
- Biotech Consultancy
- PRO Services
- Oncology Trials
- Internal Medicine Trials
- Observational Studies
- Medical Monitoring
We enhance the role of the biostatistician, they play a crucial role by accelerating timelines.
Pivotal provides high quality biostatistics deliverables for clinical development design and plans, regulatory support and effective analysis and reporting. In an increasingly regulated environment, it is crucial to work together with a biostatistician who understands the current regulatory requirements in a manner that facilitates and accelerates timelines. At Pivotal, we pride ourselves on building statisticians teams with deep regulatory knowledge and specific therapeutic expertise, matching our customers’ needs, to provide accuracy, speed and flexibility with study reporting. And, our rigorous validation and quality control processes will eliminate the need for corrections and ensure accurate reports.
Our team of biostatisticians will be involved throughout the whole trial and hence informed, engaged and proactive. They have years of clinical research experience and a strong analytical educational background to tackle our clients’ most complex trials.
Services we provide:
- Statistical Analysis Plan (SAP) development (sample size, analysis methods, data displays and interpretations)
- Derived datasets (design, development and validation)
- Patient profile reporting
- Tables, Listings and Figures (TLFs) (design, development and validation)
- Statistical analysis report
- Data Safety Monitoring Board (DSMB)
Our Biostatisticians are also trained in the use of the latest standards including Biostatistics Standardisation (ADaM) and Integration.