Clinical Biostatistics Services

Biostatistics CRO

Quanticate has been built around the expert knowledge and reputation across the industry of our statistical consultancy team over the past 24 years. Originally founded as a biostatistics clinical research organisation (CRO), biostatistical services have always been a key component of Quanticate's services as part of our heritage. Our team has experience in all phases of research and development from pre-clinical analysis to clinical and post-marketing support across a wide range of therapeutic areas. Quanticate also provides all levels of support from bespoke consultancy for protocol design through to study level analysis of Tables, Listings and Figures.

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. We pride ourselves on our expertise and the ability to show clear results to our customers. We also take a personalised approach dependent on our clients needs which forms lasting partnerships and enables our experts to transfer their biostatistics knowledge on to our customers.

Quanticate is renowned for our employees’ depth of experience in biostatistics. Typically, our statistical consultancy services focus on protocol design, calculation of sample sizes, power calculations, and/or the production of a study randomization. We also print randomization envelopes using custom-made NCR envelopes for maximum security. 

Our Clinical Biostatistics Services include:

• Pre-Clinical Studies – we provide support and advice for pre-clinical studies to ensure the study objective is being fulfilled.
   
• Protocol Input – our input includes clinical study design, sample size calculations and consultancy advice during the start up of a study.
   
• Randomization/Unblinding – we offer production of randomizations including production of emergency unblinding envelopes.
   
• Statistical Analysis Plan (SAP) and Output Shells – we optimize the use of our Consultant Statisticians to ensure innovative approaches to the statistical content of a study to increase the chances of a successful trial.
   
• 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 Quanticate standard macros within the SAS ® Programming system ensures increased efficiency when producing outputs.
   
• PK/PD Analysis - non-compartmental analysis using Phoenix WinNonlin® and associated 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 Report/Clinical Study Report – our statistical and medical writing teams collaborate to produce high quality reports.

• Interim Analysis/Data Safety Monitoring Boards (DSMBs) – we offer unblinded statistical support, PK Analysis and advice for Interim Analyses and DSMBs.
   
• Meta Analysis – our expert statisticians can advise on potentials for bias during a Meta Analysis as well as on statistical methods to use.
   
• ISS/ISE - we provide support for the integration of safety and efficacy data prior to regulatory approval.