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Patient Centricity in Clinical Trials
by Clinical Data Management Team
publish date icon December 4, 2020

Patient Centricity in Clinical Trials

This blog describes the evolution of patient centricity in clinical trials and the integration of wearable tools to enhance data.

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Using R Programming for Clinical Trial Data Analysis
by Clinical Programming Team
publish date icon October 27, 2020

Using R Programming for Clinical Trial Data Analysis

Create Tables, Listings and Figures (TFLs) using R Programming in your clinical trial data analysis, not as a replacement for, but rather as an alternative option to SAS.

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The History and Development of Pinnacle 21
by Clinical Programming Team
publish date icon October 16, 2020

The History and Development of Pinnacle 21

Pinnacle 21 has evolved and knowledge of its software has become an indispensable skill of every statistical programmer who works with CDISC standards.

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4 ways to Improve Clinical Data Quality in the Digital Era
by Clinical Data Management Team
publish date icon September 23, 2020

4 ways to Improve Clinical Data Quality in the Digital Era

Clinical Data Quality is of the utmost importance when working towards a regulatory submission. These 4 methods are a must have in the new digital era.

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Real World Evidence in Drug Development [Podcast]
by Statistical Consultancy Team
publish date icon August 5, 2020

Real World Evidence in Drug Development [Podcast]

Our statisticians discuss Real World Evidence and its importance on drug development, and how it can be used during COVID-19.

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Respiratory Clinical Trials to Support COVID-19 Survivors
by Statistical Consultancy Team
publish date icon June 16, 2020

Respiratory Clinical Trials to Support COVID-19 Survivors

Patients who survive COVID‑19 may suffer lasting lung damage. This blog explores Pulmonary fibrosis in COVID-19 and Respiratory Clinical Trial Designs.

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Clinical Trial Outsourcing Trends and Research in 2020
by Thomas Underwood
publish date icon March 10, 2020

Clinical Trial Outsourcing Trends and Research in 2020

Read the latest trends and predictions on clinical outsourcing and research due to new regulations and pressure to reduce the costs of drug development

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Big SAS Code: How to Handle Large Programs
by Clinical Programming Team
publish date icon December 11, 2019

Big SAS Code: How to Handle Large Programs

Quanticate explores how a big SAS code can be made straightforward and easy to understand, with techniques and best practices to achieve this in your SAS programs.

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The What, Why and How of Adaptive Clinical Trials
by Statistical Consultancy Team
publish date icon November 27, 2019

The What, Why and How of Adaptive Clinical Trials

Quanticate explores the rise, the issues, and challenges of Adaptive Clinical Trials and the ways to adapt your study, with examples of oncology study design.

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An Introduction to Estimands [Podcast]
by Statistical Consultancy Team
publish date icon October 25, 2019

An Introduction to Estimands [Podcast]

Quanticate Podcast: An Introduction to Estimands. Our statisticians discuss what is Estimands, why it should be used and who it impacts

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ACR Response Criteria in Rheumatoid Arthritis Clinical Trials
by Statistical Consultancy Team
publish date icon October 8, 2019

ACR Response Criteria in Rheumatoid Arthritis Clinical Trials

ACR response criteria measures the effectiveness of various medications in Rheumatoid Arthritis (RA) clinical trials. This blog also reviews techniques to assess equivalence across time points and compare treatment response curves in RA tri...

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The Expansion Phase of Phase I Oncology Trials
by Statistical Consultancy Team
publish date icon September 19, 2019

The Expansion Phase of Phase I Oncology Trials

Quanticate analyze whether having a Dose Expansion Phase in Phase I Oncology Trials is beneficial and provides information about Efficacy, Safety, Toxicity and Pharmacokinetics prior to jumping into a Phase II Study

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Estimands – What you need to know
by Statistical Consultancy Team
publish date icon September 8, 2019

Estimands – What you need to know

Estimands have become a hot topic for statisticians involved in clinical trials after the release of the ICH E9 (R1) addendum and are now being implementing into study protocols

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An Introduction to Missing Data in Clinical Trials
by Statistical Consultancy Team
publish date icon August 16, 2019

An Introduction to Missing Data in Clinical Trials

An introduction to handling the issues of Missing Data in Clinical Trials which has changed the incorporation of missing data in study results.

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Subject: Sending Emails using VBA and SAS
by Clinical Programming Team
publish date icon July 22, 2019

Subject: Sending Emails using VBA and SAS

Quanticate provide a step-by-step guide on how to send emails using SAS and Visual Basic for Applications (VBA), as well as a combination of both.

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Creating your own interactive dashboards in SAS
by Clinical Programming Team
publish date icon June 17, 2019

Creating your own interactive dashboards in SAS

Can you easily create your own interactive dashboards in SAS? In this blog, Quanticate will explore whether SAS 4GL is all you need!

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WARNING: Transposing Data using PROC SQL
by Clinical Programming Team
publish date icon June 13, 2019

WARNING: Transposing Data using PROC SQL

Quanticate outlines the in-depth problems of transposing data using PROC SQL and how tree traversal can be understood and implemented in SAS.

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Machine Learning in the Pharmaceutical Industry
by Clinical Programming Team
publish date icon May 21, 2019

Machine Learning in the Pharmaceutical Industry

Quanticate explores what Machine Learning is and the three types of Machine Learning and real-life examples from the pharmaceutical industry.

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Examples of Do Loops in SAS with PROC DS2
by Clinical Programming Team
publish date icon February 27, 2019

Examples of Do Loops in SAS with PROC DS2

With few examples and tutorials, and even fewer Pharmaceutical specific learning resources on DS2, this blog provides statisticians and programmers with real world examples of Do Loops in SAS with PROC DS2 and a basic overview of Object Ori...

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FDA Guidance for Human Gene Therapy for Hemophilia A & B
by Statistical Consultancy Team
publish date icon October 29, 2018

FDA Guidance for Human Gene Therapy for Hemophilia A & B

This blog post reviews the FDA's guidance for Human Gene Therapy (GT) for Hemophilia A & B clinical trials and what is needed to support an accelerated approval approach. Learn More

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A Guide to Phase 1 Clinical Trial Designs
by Statistical Consultancy Team
publish date icon October 17, 2018

A Guide to Phase 1 Clinical Trial Designs

Different designs used in Phase 1 Clinical Trials suit certain study types to determine the safety, tolerability and pharmacokinetics (PK) of new compounds

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Statistical Methods in Risk Based Monitoring
by Statistical Consultancy Team
publish date icon October 2, 2018

Statistical Methods in Risk Based Monitoring

This blog explores the statistical methods used in Risk Based Monitoring (RBM) and how the result of such statistical methods enables improved data integrity across a clinical trial.

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Why do a 3rd of Regulatory Submissions fail the Technical Rejection Criteria?
by Clinical Programming Team
publish date icon August 6, 2018

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

This blog post looks at the FDA's Technical Rejection Criteria for Study Data and despite demographic dataset (DM for SDTM submissions), define.xml, the Subject-Level Analysis Dataset (ADSL for ADaM submissions) and Trial summary (TS) being...

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Nutraceutical trials: demand, design and challenges
by Statistical Consultancy Team
publish date icon July 31, 2018

Nutraceutical trials: demand, design and challenges

Nutraceutical trial design presents several unique challenges for researchers. It is often the case that many companies in the sector are unfamiliar with clinical trials processes and require a design approach as manufacturers look to prove...

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[Video] Bayesian Methodology - How to Analyse Multiple Endpoints
by Statistical Consultancy Team
publish date icon July 10, 2018

[Video] Bayesian Methodology - How to Analyse Multiple Endpoints

In this Statistical Knowledge Share Video our Principal Statistician, 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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First Steps in Laboratory Dataset in SAS
by Clinical Programming Team
publish date icon June 27, 2018

First Steps in Laboratory Dataset in SAS

The laboratory dataset is one of the core safety datasets and, at first glance, it could appear intimidating. This article will illustrate checks that are worth applying at the very beginning of programming work – these could be in addition...

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Implementing Electronic Data Capture (EDC) systems in Clinical Trials
by Clinical Data Management Team
publish date icon June 4, 2018

Implementing Electronic Data Capture (EDC) systems in Clinical Trials

This Quanticate blog examines the implement of electronic data capture (EDC) systems in clinical trials by highlighting the benefits of moving away from paper-based studies, the thought behind the EDC database design and role of outsourcing

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What Defines Quality in Medical Writing?
by Medical Writing Team
publish date icon March 22, 2018

What Defines Quality in Medical Writing?

Several pieces of research say the majority of medical writing services are sold on the basis of quality, but what really is quality and why do medical writers think it is so important? Learn more about what defines quality in medical writi...

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Pharmacovigilance: The Regulatory Outlook
by Pharmacovigilance Team
publish date icon February 15, 2018

Pharmacovigilance: The Regulatory Outlook

Quanticate looks at some of the challenges and pharmacovigilance regulations the industry faces since 2012 with the introduction of GVPs, Brexit and ICH E2B(R3)

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ICH E2B(R3): Are You Ready For The New Update?
by Pharmacovigilance Team
publish date icon December 4, 2017

ICH E2B(R3): Are You Ready For The New Update?

The ICH E2B(R3) update is intended to standardize the definition of the data elements used in electronic transmission of different types of ICSRs. Learn more

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Top 3 Examples of Interactive Clinical Data Visualizations
by Statistical Consultancy Team
publish date icon September 5, 2017

Top 3 Examples of Interactive Clinical Data Visualizations

Interactive clinical data visualization is a powerful tool to investigate data and share detailed insights in an efficient way. Learn more with these 3 examples

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The Logic of a Clinical Research Organization Programmer
by Clinical Programming Team
publish date icon June 23, 2017

The Logic of a Clinical Research Organization Programmer

This blog explains how programmers within clinical research organizations work through simple requests to build a robust system using SAS, UNIX and experience.

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Therapeutic Areas for Wearable Devices in Clinical Trials
by Statistical Consultancy Team
publish date icon March 31, 2017

Therapeutic Areas for Wearable Devices in Clinical Trials

This paper explores the therapeutic areas that various wearable devices can be used in for clinical trials, drawing on examples from current and past studies.

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The History of Pharmacovigilance Infographic
by Pharmacovigilance Team
publish date icon March 27, 2017

The History of Pharmacovigilance Infographic

An infographic that looks at the history of Pharmacovigilance and its evolution over the 20th century in response to serious adverse events and patient safety

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Medical Coding in Clinical Data Management
by Clinical Data Management Team
publish date icon March 20, 2017

Medical Coding in Clinical Data Management

This blog reviews the processes, systems, tools and different coding dictionaries to perform medical coding in clinical data management

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ICH GCP E6 Addendum R2 - What do you need to know?
by Commercial Team
publish date icon February 13, 2017

ICH GCP E6 Addendum R2 - What do you need to know?

Explore the ICHGCP E6 Addendum R2 changes and what they mean for sponsors and vendors in clinical trial conduct, risk-based monitoring and emerging technologies

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The Costs Considerations when Outsourcing to a CRO
by Commercial Team
publish date icon February 6, 2017

The Costs Considerations when Outsourcing to a CRO

Learn about the cost considerations of outsourcing to a clinical research organization (CRO) compared to using internal resources for your clinical study

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The Evolution of Risk Based & Remote Monitoring
by Commercial Team
publish date icon November 25, 2016

The Evolution of Risk Based & Remote Monitoring

The future of Risk Based & Remote Monitoring, how globalisation has caused the FDA to advise risk mitigation and the fear of flouting regulatory compliance

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A Guide to the Benefits of Centralized Clinical Data
by Commercial Team
publish date icon November 18, 2016

A Guide to the Benefits of Centralized Clinical Data

Quanticate looks at the benefits of centralized clinical data services with a specialist data focused Clinical Research Organization or internally by a sponsor

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The Rise of Risk Based Monitoring [Infographic]
by Thomas Underwood
publish date icon August 16, 2016

The Rise of Risk Based Monitoring [Infographic]

This infographic presents survey data that indicates the increase in the use of risk-based monitoring and how data from trials using RBM solutions has risen

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The Role of a Statistician In a Pre-Clinical Study
by Statistical Consultancy Team
publish date icon May 13, 2016

The Role of a Statistician In a Pre-Clinical Study

The role of Statisticians within a pre-clinical study and how reducing errors can improve efficiency of the study by Quanticate.

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The Rise of Risk-Based Monitoring in Clinical Trials
by Thomas Underwood
publish date icon April 26, 2016

The Rise of Risk-Based Monitoring in Clinical Trials

This Quanticate blog post examines the rise of Risk Based Monitoring in clinical trials and growing trends from industry data in the adoption of RBM

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The Different Phases of Clinical Trials
by Medical Writing Team
publish date icon April 15, 2016

The Different Phases of Clinical Trials

Quanticate blogs on the different phases of clinical trials that are classified into 4 phases, with each potentially lasting for several years.

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Exploring CDISC Analysis Data Model (ADaM) Datasets
by Clinical Programming Team
publish date icon March 30, 2016

Exploring CDISC Analysis Data Model (ADaM) Datasets

A Quanticate blog post exploring Analysis Data Model and ADaM Datasets, and how it is widely used in the submission of clinical trial information.

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Preparing for Big Data in Pharma
by Nick Burch
publish date icon March 17, 2016

Preparing for Big Data in Pharma

Quanticate looks at how companies can prepare for Big Data in the Pharmaceutical industry. Learn more.

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Compiling the Appendices for a Clinical Study Report
by Medical Writing Team
publish date icon February 19, 2016

Compiling the Appendices for a Clinical Study Report

17 Easy steps for compiling the appendices of a clinical study report to help clinical regulatory writers in the pharmaceutical industry.

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4 Efficiencies of a Clinical Research Organization
by Commercial Team
publish date icon February 5, 2016

4 Efficiencies of a Clinical Research Organization

Quanticate explores 4 efficiencies within Clinical Research Organizations (CROs) a sponsor should for short notice requests and to maximise a partnership

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Integrated Summary Tips
by Medical Writing Team
publish date icon January 15, 2016

Integrated Summary Tips

A Quanticate blog post that looks at Integrated Summary tips and best practices for regulatory submission

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Conducting Randomization in Clinical Trials [VIDEO]
by Statistical Consultancy Team
publish date icon December 4, 2015

Conducting Randomization in Clinical Trials [VIDEO]

A quanticate blog exploring the processes of randomization in clinical trials and how if conducted correctly it can help to ensure the success of the trial.

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The Challenges of Writing Patient / Safety Narratives
by Medical Writing Team
publish date icon November 24, 2015

The Challenges of Writing Patient / Safety Narratives

A blog looking at the number of unique challenges that a medical writer might encounter while writing / managing patient / safety narrative projects.

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Your SAS Secrets Exposed! [4 SAS Tips]
by Clinical Programming Team
publish date icon July 14, 2015

Your SAS Secrets Exposed! [4 SAS Tips]

Explanations and examples of 4 SAS tips to use in your day to day SAS Programming picked up from other programmers.

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Efficacy Endpoints in Oncology and RECIST Criteria
by Clinical Programming Team
publish date icon January 9, 2015

Efficacy Endpoints in Oncology and RECIST Criteria

Quanticate provides an overview of efficacy endpoints in oncology studies and the RECIST (Response Evaluation Criteria In Solid Tumours) method.

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Prentice-Wilcoxon Test for Paired Time-to-Event Data
by Statistical Consultancy Team
publish date icon May 16, 2014

Prentice-Wilcoxon Test for Paired Time-to-Event Data

Quanticate's latest blog explores practical applications of the Prentice-Wilcoxon Test for paired time-to-event data in clinical studies

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7 Frequently asked Questions on Clinical Study Design
by Statistical Consultancy Team
publish date icon January 31, 2014

7 Frequently asked Questions on Clinical Study Design

A Quanticate blog on frequently asked questions on Clinical Study Design in the area of Bayesian Statistics and a focus on Phase 1 studies.

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Multiple Forest Plots and the use of SAS Macros
by Clinical Programming Team
publish date icon July 5, 2013

Multiple Forest Plots and the use of SAS Macros

Quanticate looks at the SAS/Graph Annotation option with SAS Macros to allow the creation of multiple Forest Plots.

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Traceability - Where is Your Clinical Information?
by Commercial Team
publish date icon September 28, 2011

Traceability - Where is Your Clinical Information?

Quanticate blogs on the importance of traceability of clinical information and challenges of meeting regulatory requirements with outsourced clinical data

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Becoming a Regulatory Writer
by Medical Writing Team
publish date icon April 19, 2011

Becoming a Regulatory Writer

What to consider and research when choosing a career as a regulatory writer in the clinical world by Quanticate.

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An Introduction To Biostatistics In Clinical Trials
by Statistical Consultancy Team
publish date icon March 29, 2011

An Introduction To Biostatistics In Clinical Trials

Quanticates statistical consultancy team gives an introduction to biostatistics in clinical trials and the topics our company blog will cover.

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