Statistics is regarded as one of the core disciplines of pharmaceutical research, which relies on the collection of objective data to demonstrate clinical effect. Biostatistical consulting covers issues from study design and strategies, to the analysis of study data and informed interpretation of results. The benefits of Statistical Consultancy are:
Supervising data collection to provide meaningful measurable quantities
Coding and manipulating data for a suitable analysis, having selected from a wide array of possible analysis options
Intepreting data with an appreciation of the play of random chance
An honest and objective external voice
Time to explore alternative approaches outside of the day-to-day demand of running a live study
Cost effective trial designs to suit your budget
Reach your IND Submission, publication or research goals as you choose the right expertise to match your needs from a range of consultants. Due to our biostatistical heritage, Quanticate has been an industry leader in biostatistical consulting for over 25 years.
Having such a breadth of experience among our staff allows us to provide you with the needed expertise for your projects. From study start up through to the final analysis, from Phase I to submission, and post-approval support.
An optimally designed trial can reduce your costs and save time, either by requiring a smaller sample size or by stopping a trial earlier in time without continued wasted efforts. Our highly skilled statistical consultancy team will ensure your study is designed to meet regulatory requirements for approval or post-submission, and can support you with:
Writing statistical sections of complex protocols including master protocols
Simulations to estimate and optimise study sample size
Novel designs across drug development programmes
Pharmacokinetic analysis and reporting
Data Safety Monitoring Boards (DSMBs)
Best statistical practice including Bayesian Methods
Adaptive trial designs and interim analyses
Efficient support for biosimilars
Incorporating mHealth apps, wearable and ePro solutions
Registry studies
Health economics and outcomes research
Real world evidence/data
These sources requires specific methods and an understanding of Observational Studies to ensure the correct conclusions are drawn. Plan the correct analytical methods to deal with these data sources and ensure all potential source of bias are identified and properly managed.
The definition of a study estimand is a crucial part of study planning since it specifies the scientific question of interest. Define the correct study estimand by liaising with your clinical team to ensure you specify all components are consistent with the current regulatory framework.
Don’t let missing data jeopardize your study performance. Our biostatistical consulting offers a range of statistical methodologies to handle and prevent missing data, including:
Specification of multiple imputation models
Simulation studies to assess sensitivity of the main results to alternative scenarios
Evaluation of impact of a given methodology in an equivalence/non-inferiority context
Data quality oversight through the creation of statistical monitoring reports
Development of protocols and SAPS for a risk-based approach to monitoring
The creation of a Risk Assessment Categorization Tool (RACT) to enable Centralized Statistical Monitoring
For customers who require support on their clinical trial reporting, you will receive the additional value of our statistical consultancy expertise including:
Karen Ooms is responsible for overseeing the Statistics department at Quanticate. Karen is a Chartered Fellow of the Royal Statistical Society and has a background in biostatistics spanning over 25 years.