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 our clients the needed expertise for their projects. From study start up through to the final analysis, from Phase I to submission, our statistical consultants are among the leaders in their respective areas enabling our clients to have the ability to choose expertise from a range of consultants to match their needs and reach their IND submission, publication or research goals.
We offer biostatistical consultancy in areas such as:
An optimally designed trial can reduce costs and save time, either by requiring a smaller sample size or by stopping a trial earlier in time without continued wasted efforts. Our statistical consultancy team have been involved with a broad spectrum of clinical study designs across a wide range of therapeutic areas and can draw upon their experiences to support your clinical development programme. We can support with:
Our Statistical consultants are experienced in handling data and statistical methodologies that lie beyond the standard randomized controlled clinical trial (RCT), our consultants are highly skilled in appropriate use of other data sources including:
Due to their observational nature, analysing these data requires specific methods and an understanding of Observational Studies to ensure the correct conclusions are drawn. Our consultant will be able to plan the correct analytical methods to deal with these data sources and ensure all potential source of bias are identified and properly managed.
Fundamentally linked with trial design, the definition of a study estimand is a crucial part of study planning since it specifies the scientific question of interest. Our team can provide support in the definition of the correct study estimand by liaising with the clinical team and specify all estimands component consistently with the most recent Regulatory framework.
Whether it is missing data in clinical trials due to poor patient engagement or from a lack of data in Observational studies, our biostatistical consulting offers a range of statistical methodologies to handle missing data including:
With constantly evolving guidance and various opportunities for improved clinical trial efficiency in the recent ICH E6 R2 Addendum, our statistical consultants understand the demand and practicality of embracing new technologies and methods and offer the following:
Support in the creation of a Risk Assessment Categorization Tool (RACT) to enable Centralized Statistical Monitoring