CALL US +44 (0)1462 440 084 | +1 919-882-2016 | Contact | Submit RFI

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.

Read More
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.

Read More
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.

Read More
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.

Read More
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.

Read More
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.

Read More
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?

Read More
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.

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

Pharmacovigilance: The Regulatory Outlook

Pharmacovigilance Team

2012 saw the introduction of good pharmacovigilance practices (GVPs) in the European Union (EU) and since then, the industry has experienced a huge amount of change, including the introduction of the new EudraVigilance system in 2017. The new system, due to be fully implemented in 2019, is a European data processing network and management system designed to allow companies to report and evaluate suspected adverse reactions both during drug development and on an ongoing basis.

Read More
Topics: Regulatory Requirements, Good Clinical Practice (GCP), Eudravigilance, New Pharmacovigilance Legislation, Good Pharmacovigilance Practices, European Medicines Agency, ICH E2B(R3), International Conference on Harmonisation (ICH), Safety Database, GVP Module VI

Risk-Based Monitoring and the Need for Programmers and Statisticians

Statistical Consultancy Team


The ICH E6 on Good Clinical Practice was updated on 9 November 2016, the first addendum for 20 years. Sections 5.0 on Risk and 5.18.3 on Extent and Nature of Monitoring in particular created an increased need for Risk-Based Monitoring (RBM) and Centralized Monitoring (CM). The details of how this may be covered and the increasing evolution of a risk in the industry have been noted. The required changes involved create a number of different team roles. These include opportunities for biostatisticians and statistical programmers - players who may not have been so directly involved in onsite monitoring, a more traditionally clinical domain.

Read More
Topics: Source Data Verification (SDV), On-Site Monitoring, Visualization, Fraud Detection, Risk Based Monitoring, Centralized Monitoring, ICHGCP E6, International Conference on Harmonisation (ICH)

Welcome to The Quanticate Blog

We aim to provide information and support written by our experienced staff. We want to share our knowledge and create an archive of information that you will be able to engage with, share and comment on.

Subscribe to Email Updates

Blog Suggestions

Most Read

Posts by Topic

Expand all