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:
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:
Go beyond the industry recognized standard of randomized controlled clinical trials (RCT), and get your drug approved using alternative trial types from the following sources:
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:
Reduce your trial budget with a reduction in on site monitoring and improve your data integrity as you discover data anomalies through a risk-based approach with the following methods:
For customers who require support on their clinical trial reporting, you will receive the additional value of our statistical consultancy expertise including: