Biostatistical Consultancy Services

Reduce your cost of drug development and save time to submission with expert statistical methodologies and well-designed trials.

Why Statistical Consultancy? Clinical Study Design Alternative Trial Types Estimands Missing Data Risk Based Approaches & Regulatory Submissions Study Reporting Biostatistical Consultancy for Top Pharmas

Why Statistical Consultancy?

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

Grow up your business

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 goals

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.

Clinical Study Design

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

Alternative Trial Types

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:

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.

Estimands

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.

Missing Data

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

Risk Based Approaches & Regulatory Submissions

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:

Localized regulatory support including an independent review of submission dossiers

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

Study Reporting

For customers who require support on their clinical trial reporting, you will receive the additional value of our statistical consultancy expertise including:

Investigator Brochures & Development Safety Update Reports (DSUR)

Exploratory analysis and modelling (e.g. dose selection, Bayesian Modelling)

Integrated Summaries of Safety and Integrated Summaries of Efficacy (ISS/ISE)

Why Quanticate's Biostatistical Consultancy is trusted by Top Pharmas

Presence across industry as statistical experts

High employee retention rate

An Executive team made up of statisticians

Ability to work on-site globally

Personalised and flexible service

Strong governance approach

Reduce your cost of drug development and save time to submission

Team Leaders

Karen Ooms

Executive Vice President, Head of Statistics

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.