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Remote Monitoring During Clinical Trials, a Risk Based Approach

Medical Writing Team

Within the last few decades the number and complexity of clinical trials has increased considerably, not only across the industry but within individual companies.  With this increase comes the enhanced pressure of effectively monitoring these trials. 

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Topics: Regulatory Requirements, Clinical Trials, Good Clinical Practice (GCP), Clinical Data Storage, Case Report Form (CRF), Remote Monitoring, Adverse Events (AEs), Ethics, On-Site Monitoring, Risk Based Monitoring, Centralized Monitoring

[Published Journal] Using Observational Studies to Investigate the Relationship Between Fatigue and Work Disability

Statistical Consultancy Team

Our Statistical Consultancy Team recently collaborated on a study to investigate the long-term relationship between fatigue and work disability in patients initiating treatment with etanercept for rheumatoid arthritis (RA) or ankylosing spondylitis (AS); and this work has now been published. (https://arthritis-research.biomedcentral.com/articles/10.1186/s13075-018-1598-8)

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Topics: Rheumatoid Arthritis (RA), Observational Studies, Inflammatory Rheumatic Diseases, Observation Longitudinal Database, Statistical Consultancy

Why do a 3rd of Submissions fail the Technical Rejection Criteria?

Clinical Programming Team

At the July 25th PhUSE Webinar Wednesday, Ethan Chen (Director, Division of Data Management Services and Solutions Office of Business Informatics, FDA CDER) gave us a glimpse of the FDA’s view on Technical Rejection Criteria for Study Data. Those that were at the US Connect Conference earlier in the year may have seen this already.

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Topics: CDISC Guidelines, CDISC SDTM, SDTM Domains, CDISC, FDA, SAS Programming, SDTM, CDISC Standards, ADaM Datasets, Define.xml

Nutraceutical trials: demand, design and challenges

Statistical Consultancy Team

Food ingredient and nutraceutical manufacturers are increasingly looking to market their products by substantiating their unique health benefits.

There are many generic, widely used claims - in the EU, Article 13.1 of the European Food Safety Authority’s (EFSA) EC Regulation permits manufacturers to use some 4,6371 that pertain to vitamin and mineral content.

This proliferation is driving manufacturers to develop unique claims to use in marketing efforts, which in turn has led to a significant growth in demand for nutraceutical trials.

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Topics: Regulatory Requirements, Clinical Study Design, Biostatistics Consulting, Statistics, Nutraceutical Trials

Bayesian approaches to use historical data in the analysis of clinical trials

Statistical Consultancy Team

The BAYES 2018 Bayesian Biostatistics workshop took place from the 20th to the 22nd of June, and was an extraordinary chance to discuss how Bayesian methodology can be used within the pharma industry.

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Topics: Bayesian Statistics, Bayesian Study Design, Bayesian Methods, Clinical Study Design, Historical Data, Biostatistics Consulting, Statistics, Statistical Consultancy

[Video] Bayesian Methodology - How to Analyse Multiple Endpoints

Statistical Consultancy Team

In this Statistical Knowledge Share Video our Principal Statisticians, Sonia, presents an example of Bayesian Methodology using simulated data and examines how to analyze Multiple End Points in Clinical Trials.

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Topics: Bayesian Statistics, Bayesian Methods, SAS Programming, Statistics, Statistical Knowledge Share, Multiple Endpoints

First Steps in Laboratory Dataset in SAS

Clinical Programming Team

The laboratory dataset is one of the core safety datasets and, at first glance, it could appear intimidating, with multiple tests and visits per patient. This article will illustrate checks that are worth applying at the very beginning of programming work – these could be in addition to the standardized process of domain validation.

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Topics: Statistical Programming, CDISC Guidelines, CDISC SDTM, SDTM Domains, CDISC, Case Report Form (CRF), Clinical Programming, SAS Programming, SDTM, CDISC Standards, SAS Datasets, SAS Macros, SAS, Laboratory Datasets, Safety Dataset

Implementing Electronic Data Capture (EDC) systems in Clinical Trials

Clinical Data Management Team

Clinical Trial Management Systems (CTMS) are an important part of every clinical trial. Selecting the right CTMS helps address inefficiencies on the operational side of research, such as clinical trial planning, preparation, performance and reporting. As more and more pharma and biopharma sponsors start to recognize the potential opportunities that exist with EDC-CTMS integration, there is a growing need to address the complex process of electronic data capture (EDC) implementation.

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Topics: CDISC, Case Report Form (CRF), Electronic Data Capture, eCRF, Outsourcing Solutions, CDISC CDASH, Clinical Data Management, Paper-Based Studies

What Defines Quality in Medical Writing?

Medical Writing Team

A quick trawl of the internet reveals that the majority of medical writing services are sold, in part, on the basis of quality, but what really is quality and why do medical writers think it is so important?

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Topics: Medical Writing, Clinical Trial Documentation, Clinical Documents, Clinical Study Report, Quality Assurance

[Video] Tipping Point Analysis in Multiple Imputation for Binary Missing Data

Statistical Consultancy Team

In this Statistical Knowledge Share Video our Senior Statisticians, Niccolo, presents an example on simulated data of Tipping Point Analysis in Multiple Imputation for Missing Data.

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Topics: Multiple Imputation, Statistics, Tipping Points Analysis, Missing Data, Statistical Knowledge Share

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