Biostatistics
Strategic Planning for Clinical Development
- Endpoint selection
- Study design
- Submission strategy
- SBA Review
- FDA communication
Study Design
- Study design aligned with drug development strategy
- Supporting Fast Track Designation or Breakthrough Designation
- Adaptive design for early phase dose escalation oncology trials
- Adaptive design for oncology compounds phase 1-3 seamless design
- Innovative design for rare disease indications
Protocol Statistical Section
- Randomization scheme,
- Power and sample size calculation,
- Interim analysis
SAP development
Publication support
CSR/NDA/BLA/EMEA submission
PMA/510(k) submission for medical devices
IDMC support (Charter and SAP)
PK/PD data analysis and modeling
Expert Biostatistics Consulting
- Adaptive Design or Innovative Design
- Adaptive Design for Oncology Trials
- Innovative Design for Rare Disease (Cross Over Design or Randomized Delayed Design)
- Simulation for Operating Characteristics for study design
- Trial Event Projection
- Power and Decision Boundary and Analysis Using R
- Statistical comparison using virtual matched historical data
- Expert Statistician programming support
- Bootstrapping projecting final P-values
- Expectation–maximization (EM) algorithms and Bayesian classification method for blinded data analysis to have a sense of treatment effect
- Data mining, early prediction, meta-analysis
- Signal detection and monitoring
- Exploratory analysis for planning and designing for new studies
Other Services
SAS Programming
CDISC data standards, industry data standards, and FDA compliance are always at the heart of every statistical programming task that we undertake.
FSP
We offer a range of ‘flexible’ contractual engagement models ranging from project outsourcing and functional insourcing (FSP).