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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.

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

Top 3 Examples of Interactive Clinical Data Visualizations

Statistical Consultancy Team

Nowadays, vast amounts of data are collected during any clinical trial and it is essential for pharmaceutical sponsors to understand these data in great detail to make accurate decisions.

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Topics: ADaM Datasets, Adverse Events (AEs), SDTM, Visualization, Technology Trends, Statistics, Biostatistics Consulting

A Review of the Annual PhUSE 2016 Conference

Clinical Programming Team

A number of team members were able to represent Quanticate at the PhUSE 2016 annual conference in Barcelona. The PhUSE annual conference is an opportunity for programmers and statisticians to both learn from and share cutting edge knowledge with the pharmaceutical industry. This year, Quanticate presented on producing high quality SAS graphics using the advanced Graphical Template Language (GTL) to bring individual plots together to aid analysis without sacrificing any aesthetical properties in the process. Conference attendees were spoilt for choice with approximately 5 simultaneous presentations every half-hour across 15 streams in total. Here are some interesting presentations which the team enjoyed over the conference duration.


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Topics: Visualization, Clinical Programming, SAS Graph, Conferences, SAS Programming, Programming R

4 Efficiencies of a Clinical Research Organization

Commercial Team

How can the efficiency of a Clinical Research Organization (CRO) be understood? As CROs provide various services to study sponsors, their overall efficiency at providing these services and internal processes to allow these to be delivered can be broken down into a number of elements with their own unique efficiency.

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Topics: CRO Project, CRO Efficiency, Clinical Research Organization, Visualization, Micro Efficiencies, Project Management

Nick Burch Discusses Big Data in Clinical Trials [Video]

Nick Burch

Nick Burch, CTO at Quanticate discussed Big Data in Clinical Trials at the 4th Annual Clinical Data Integration and Management conference this year in Princeton, NJ. His presentation is titled: 'The Myth of the Big Data Silver Bullet - Why Requirements Still Matter'


We've all heard the hype - Big Data will solve all your storage, processing and analytic problems effortlessly! Some moving beyond the buzzwords find things really do work well, but others rapidly run into issues. The difference usually isn't the technologies or the vendors per-se, but their appropriateness to the requirements, which aren't always clear up-front.

Big Data, and the related area of NoSQL, are actually a broad range of technologies, solutions and approaches, with varying levels of overlap. Sadly it's not just enough to pick "a" Big Data solution, it needs to be the right one for your requirements. In this talk, we'll first do a whistle-stop tour of the different broad areas and approaches of the Big Data space. Then, we'll look at how Quanticate selected and built our Big Data platform for clinical data, driven by the needs and requirements. We won't tell you what Big Data platform you yourself need, but instead try to help you with the questions you need to answer to derive your own requirements and approach, from which your successful Big Data in clinical trials solution can emerge!


Big Data in Clinical Trials Video 


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Topics: Clinical Trials, Clinical Data Storage, FDA, Clinical Study Design, Large Datasets, CRO Efficiency, Visualization, Accessible Data, Mobile Device, Big Data, Drug Development, Technology Trends

Hitting New Targets - EPC Interview with David Underwood

David Underwood

European Pharmaceutical Contractor held an interview with Quanticate CEO; David Underwood, asking how he started in the pharmaceutical industry, the reasons behind Quanticate's recent success and future trends as well as regulations in the industry.

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Topics: Clinical Trials, CEO's Insight, Visualization, Adaptive Trial Design, Bayesian Methods

Efficient Data Reviews and Quality in Clinical Trials [Video]

Statistical Consultancy Team

This video is presented by Kelci Miclaus from SAS JMP who was a speaker at Clinical Data Live 2013. Her presentation was is titled: 'Efficient Data Reviews and Quality in Clinical Trials'.

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Topics: Bayesian Statistics, Randomization, Serious Adverse Events (SAEs), Quality Control, CDISC, SAS Programming, Remote Monitoring, On-Site Monitoring, FDA, Visualization, Standardization, Remote Data Capture, Source Data Verification (SDV), Additional Monitoring, Efficient Data Review, Fraud Detection, Patient Safety

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

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

How a Centralized Approach to Data Impacts Clinical Study Design

Statistical Consultancy Team


In today’s environment, one of the keys to accelerating drug development decisions comes from ready access to historical data. The introduction of the Centralized Service Provision (CSP) enables data across study phases and programmes to be accessed as easily as within the same study, due to the commonality of structure.

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Topics: Standardization, Clinical Study Design, Centralization, Biostatistics Consulting, Visualization

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