Biostatistical Consulting Services | Statistical Consultancy

Partner with the leading niche Statistical Consultancy CRO

Due to our biostatistical heritage, Quanticate has been an industry leader in biostatistical consulting for 30 years.

Reach your IND Submission, publication or research goals as you choose the right expertise to match your needs from a range of consultants.

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.

The benefits of 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.

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

Interpreting 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

Clinical Study Design and Reporting

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 programs

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

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)

Alternative Trial Types

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. Go beyond the industry recognised standard of randomised 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

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.

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:

Localised Regulatory Support

Including an independent review of submission dossiers

Learn more about regulatory submissions

Data Quality Oversight

Through the creation of statistical monitoring reports

Learn more about data quality oversight

Development of Protocols and SAPS

For a risk-based approach to monitoring

Learn more about risk-based monitoring

Creation of a Risk Assessment Categorisation Tool (RACT)

To enable Centralised Statistical Monitoring

Learn more about centralised statistical monitoring

Don’t let missing data jeopardise 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

Discover the benefits of statistical consultancy for clinicals in our free whitepaper

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Why Us?

Globally Recognised Biometric CRO

Presence across industry as statistical experts

All About People

High employee retention rate

Over 30 Years of Industry Heritage

An Executive team made up of statisticians

Global Reach

Ability to work on-site globally

Tailored Solutions

Personalised and flexible service

Premium Quality

Strong governance approach

Biostatistical Consultancy Services

Partner with the leading niche Statistical Consultancy CRO