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Longitudinal Observational Data in a Paediatric Disease Registry

Statistical Consultancy Team

The use of population-based disease registries to support ongoing data collection for long-term safety and clinical outcomes is becoming increasingly common. Data collection methods within registries can vary in terms of completeness and quality. This particular example arose from support to a post-registration commitment for marketing authorisation of a paediatric drug and aims to provide some insight to the techniques and strategies used to monitor paediatric development (growth, sexual maturation) and clinical outcomes of varying severity. The challenges of accounting for irregular follow-up and associated biases are illustrated, and potential statistical solutions described. Recommendations for future reporting are presented as part of the conclusions. 

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Topics: Statistical Programming, Randomization, Paediatric Disease Registry, Outcomes Research, Real World Data, Observation Longitudinal Database

Using the Statistical Programming Language R in the Pharma Industry

Statistical Consultancy Team

The statistical programming language R is often underrated within the Pharmaceutical Industry. Often the default is to pay for expensive software when R could be a viable option. R is freely available and runs on almost all operating systems including Unix, MacOS, and Microsoft Windows.

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Topics: Statistical Programming, Programming R, Visualization, Large Datasets

Complex Randomization in Clinical Trials Need Not Be Complex

Statistical Consultancy Team

 

Whilst delivering statistical consultancy to one of our clients, we designed a clincial trial with five treatment arms: three were various doses of the active compound, one arm was a positive control and the final arm was a negative control.

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Topics: Statistical Programming, Clinical Study Design, Interim Analysis, Randomization

Overview of Receiver Operating Characteristic (ROC) Curves in SAS

Statistical Consultancy Team

The repeated dosing of some drugs can induce injury to the human liver. Regular monitoring of biomarkers assayed in blood samples may help to diagnose safety issues sooner. There is interest in developing new biomarkers that are more specific than the standard tests [e.g. Alanine Transaminase (ALT)] commonly used. 

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Topics: Statistical Programming, SAS Programming, Biomarkers, ROC Analysis, ROC Curve

Performing CDISC Compliant Pharmacokinetic Analyses

Statistical Consultancy Team

 

The Clinical Data Interchange Standards Consortium (CDISC) is a global not-for-profit organization that develops standards to support the acquisition, exchange, submission, and archive of data in clinical research. The mission of CDISC is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.

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Topics: Statistical Programming, Pharmacokinetics and Pharmacodynamic, CDISC SDTM, CDISC, SDTM, Bioequivalence, PK Analysis, ADaM Datasets

SAS Business Intelligence - A Perceptive Vision in Clinical Trials

Clinical Programming Team
Tables, listings and figures are part of day to day clinical submissions. Hence it would be useful if statisticians/clients could easily analyse the study data through different time points. This allows for better decisions because you are able to view outputs while the study is on going, this visualisation during a study can allow for great efficiencies as decisions can be made earlier in the clinical trial.
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Topics: Statistical Programming, CDISC SDTM, SDTM Domains, CDISC, SAS Programming, SDTM, PK Analysis, Visualization, SAS BI, SAS Business Intelligence, SAS Web Report Studio

An Introduction to Industry Training Course Review - Statisticians in the Pharmaceutical Industry

Statistical Consultancy Team

A Member of Quanticate’s Statistical Consultancy Team writes about their experiences whilst attending the course entitled “PSI Introduction to Industry Training Course”.

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Topics: Statistical Programming, Pre-Clinical Study, Biostatistics Consulting, Statisticians in the Pharmaceutical Industry (PSI)

CDISC SDTM v3.1.2 Theory and Application

Clinical Programming Team

A member of the Clinical Programming Team writes about their experience at the CDISC interchange in Brussels held on 11th-12th April 2011.

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Topics: Statistical Programming, CDISC Guidelines, CDISC SDTM, SDTM Domains, CDISC, Standardization, Clinical Programming, SAS Programming, CDISC Interchange

Clinical SAS Programming – Working Efficiently with Large Datasets

Clinical Programming Team

Issues of Large Datasets

Numerous SAS® programmers experience problems when working with large SAS® datasets that have millions of rows, hundreds of columns and are close to the size of a gigabyte or even more.

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Topics: Statistical Programming, Clinical Programming, SAS Programming, Large Datasets

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