Partner with the leading niche Biostatistics CRO
At Quanticate, our biostatisticians have a desire for quality and implement the best approach to a client situation/scenario to ensure correct analysis without an over-complex process. By using the appropriate tools, we are able to demonstrate the efficacy of a drug and present the results in the clearest way possible.
Biostatistics is necessary for all investigational drug or device development programmes to determine the efficacy and effectiveness in clinical trials. This includes the study designs, study conduct, determining the most effective data collection points and how analysis and reporting should be performed.
Why Us
Trusted by Top Pharma
We are trusted by top pharmaceuticals as our personalised approach forms lasting relationships and enables our experts to transfer their biostatistics knowledge on to our customers.
Expert Knowledge
A Range of Services
Quanticate provides all levels of support from bespoke biostatistical consultancy for protocol design, calculation of sample sizes, power calculations, and/or the production of study randomisation, through to study level analysis of Tables, Listings and Figures. We even provide support and advice for pre-clinical studies to ensure the study objective is being fulfilled.
Therapeutic Experience
Quanticate has experience across a wide range of therapeutic areas and all phases of research and development. Our scientific principles will guide you throughout your trial, ensuring high quality data with your clinical trial reporting to support your regulatory submission.
Study Set-Up
Our services provide a solid foundation for your clinical studies, from protocol development, randomisation, and unblinding procedures to the creation of Statistical Analysis Plans (SAP) and thorough reviews of Case Report Forms (CRFs) to ensure data alignment with trial objectives, ultimately enhancing study success.
Protocol Review & Writing
Our input includes writing of statistical analysis sections, clinical study design, sample size calculations and consultancy advice during the start up of a study.
Randomisation & Unblinding
Creating Statistical Analysis Plans (SAP) and Output Shells
We ensure innovative approaches to the statistical content of a study to increase the chances of a successful trial. By using standardised output shells, we ensure a smooth transition to Programming when using our validated macros.
Interim Analysis/Data Safety Monitoring Boards (DSMBs)
We offer support at the start of the trial to set up the documentation for DSMBs and study designs to incorporate interim analysis.
Statistical Review of CRFs
With cross functional support for Clinical Data Management customers, CRFs are reviewed to ensure data collection endpoints are appropriate and necessary for the trial's objectives.
Study Reporting
Our study reporting services ensure precise and regulatory-compliant presentation of trial data. We specialise in creating integrated summaries, conducting meta-analyses, and adhering to CDISC standards. Our team enhances efficiency in output production and performs detailed PK/PD analyses, ensuring high-quality statistical reports and thorough review of clinical study reports (CSRs).
ISS/ISE
We provide support for the integrated summaries of safety and integrated summaries of efficacy data prior to regulatory approval.
Meta Analysis
Our expert statisticians can advise on potentials for bias during a Meta Analysis as well as on statistical methods to use.
Clinical Data Interchange Standards Consortium (CDISC)
Using CDISC standards ensures that the data used in the outputs produced complies with regulatory standards.
Output Production
Using your systems or Quanticate's standard macros with SAS ® Programming and R Programming ensures increased efficiency when producing study report outputs.
PK/PD Analysis
Non-compartmental analysis using Phoenix WinNonlin® and statistical analysis with the relationship between exposure and response modeled using non-linear models and the use of non-linear mixed effect modeling.
Production of Statistical Reports/Statistical Review of Clinical Study Reports (CSRs)
Our statistical and medical writing teams collaborate to produce high-quality reports which display the study reporting results of trials. These are then used by Medical Writing in the creation of CSRs. We also review these CSRs from a statistical perspective to ensure statistical integrity is upheld.
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