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.
Clinical Trial Design and Reporting
An optimally designed study 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.
Alternative Trial Types
These sources require 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 sources 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.
- Data Quality Oversight: Through the creation of statistical monitoring reports.
- Development of Protocols and SAPS: For a risk-based approach to monitoring.
- Creation of a Risk Assessment: Categorisation Tool (RACT)
To enable 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:
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Specification of multiple imputation models
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Simulation studies to assess sensitivity of the main results to alternative scenarios
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Evaluation of impact of a given methodology in an equivalence/non-inferiority context
Discover the benefits of statistical consultancy for clinical trials in our free whitepaper
