Biostatistics Services
Quanticate is renowned for our employees' depth of experience in biostatistics. Our biostatistics services usually involve producing statistical analysis plans, generating tables, listings and figures, and performing statistical analyses. Quanticate also offers the option of immediate responses to your short-term statistical needs. 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:
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Pre-Clinical Studies – we provide support and advice for pre-clinical studies to ensure the study objective is being fulfilled.
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Protocol Input – our input includes clinical study design, sample size calculations and consultancy advice during the start up of a study.
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Randomization / Unblinding – we offer production of randomizations including production of emergency unblinding envelopes.
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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.
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Clinical Data Interchange Standards Consortium (CDISC) – using CDISC standards ensures that the data used in the outputs produced complies with regulatory standards.
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Output Production – using Quanticate standard macros within the SAS ® Programming system ensures increased efficiency when producing outputs.
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PK/PD Analysis - modeling the relationship between exposure and response using nonliner models and nonlinear mixed effect modeling.
- Production of Statistical Report/Clinical Study Report – our statistical and medical writing teams collaborate to produce high quality reports.
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Interim Analysis / Data Safety Monitoring Boards (DSMBs) – we offer unblinded statistical support and advice for Interim Analyses and DSMBs.
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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.
I am sending this to you because I have recently worked with a member of your group and I wanted you to know how impressed I have been with their work. We recently received an extremely large data package for an ongoing clinical trial that needed summarizing and reporting out to an external Data Management Committee in a very short space of time. Under the leadership of Fiona, three members of your teams - Rhiannon, Paul, and Rupinder – managed to meet the deadlines and deliver some really high quality work. There were a number of issues with the project – the datasets were delivered later than expected with no flexibility on the delivery date, the “final” dataset kept being updated, and the team kept asking for different additional graphics as they started to see the blinded data, but everyone from Quanticate coordinated well and delivered on time!
