PROTECT YOUR STUDY FROM FAILURE & AVOID EXCESSIVE OVERHEAD
In any research project, the plan for data collection and analysis is the most vulnerable and critical phase. Poor data collection and management strategies can result in misleading and even damaging results from your investment.
Our research team understands the importance of data management and quality biostatistics; we can develop a customized plan that meets your unique needs. This protects your trial from false negatives and protects your investment by ensuring that you have enough participants to find your product's effects while also protecting you from wasted funds on samples which are too large to produce meaningful results. The end result of this strategy is a timely, cost-effective research project.
Research Design
- Experimental Design Consulting
- Endpoint Selection
- Development of Measurement Instruments
- Sample Size / Power Calculations
- Study Protocol Development
- Study Protocol Review
- Informed Consent Doc Development
During Your Study
- Data Management Plan
- Statistical Analysis Plan (SAP) Development
- Randomization and Blinding
- Trial Site Initiation
- Database Design, Development, and Coding
- Interim Analyses
After Your Study
- Data Collection
- Data Review & Cleaning
- Data Analysis
- Data Interpretation
- Data Archival
- FDA Reports
- Creation of Tables
- Manuscript Development
Our Specializations
01
Outcome Measure Creation & Validation
Endpoint measurement is critical for a trial's success. Without endpoint measurement accuracy and precision, your trial may fail regardless of your products effects. Our statisticians are experts at measurement instrument development and validation.
We can assist in selecting suitable measure for your endpoints or develop a measurement approach specific to your product's effects.
02
Sample Size Calculation or Validation
Sample size for a study can be tricky. Undersampling can produce false negatives, while oversampling wastes valuable research funds.
The key to this is a power analysis based on known effect sizes. Our team can conduct this analysis allowing you to determine the perfect size for your study.
03
Data Analysis
You may have an abundance of data but don't know where to begin analyzing it in a way that leads to meaningful scientific evidence.
Our team can assess your data and conduct a full analysis meeting FDA quality standards. This allows you to develop a full scientific manuscript with the evidence you already have.
ANALYSIS PLANS CUSTOMIZED FOR YOUR NEEDS
Our procedures ensure that the quality and privacy of your data are protected during collection, analysis, and reporting. Data are cleaned, reviewed internally, coded, and stored internally to ensure the integrity of your project.
Our statistical analysis plans are customized to your trial or research study and developed to maximize your investment. While many statisticians simply pick and choose basic analytical methods, we take into consideration your objectives, the nature of the data, and other unique factors to ensure that all noteworthy findings are identified and reported.