In this blog we examine the use of R for programming datasets when performing statistical analysis in the pharmaceutical industry.
In this blog we examine the use of R for programming datasets when performing statistical analysis in the pharmaceutical industry.
This blog describes the evolution of patient centricity in clinical trials and the integration of wearable tools to enhance data.
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.
Pinnacle 21 has evolved and knowledge of its software has become an indispensable skill of every statistical programmer who works with CDISC standards.
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.
Our statisticians discuss Real World Evidence and its importance on drug development, and how it can be used during COVID-19.
RTOR can reduce the approval time for Oncology Clinical Trials without affecting the safety and effectiveness of the treatment.
Patients who survive COVID‑19 may suffer lasting lung damage. This blog explores Pulmonary fibrosis in COVID-19 and Respiratory Clinical Trial Designs.
Regulatory Writing is used to create a variety of clinical documents. Such clinical trial documentation includes clinical study reports. Learn more
Remote monitoring in clinical trials has never been so popular. This article explains a risk-based approach to remote monitoring and remote SDV
This blog provides a background on CDISC SDTM Standards, and the advantages of SDTM's application
An Adaptive Randomization method based on a Patient's Characteristics used in phase 2 and phase 3 clinical trials that focuses on personalizing medication for rare diseases and adaptive trial design.
As industry regulators and study participants seek disclosure of information in clinical trials, medical writers are creating Plain Language Summaries
Stay up to date with the latest statistics and scientific resources on the novel coronavirus (covid-19) pandemic
Read the latest trends and predictions on clinical outsourcing and research due to new regulations and pressure to reduce the costs of drug development
In this article we share our experience of a recent integration using the ADaM standards in order to ensure the safety and effectiveness of interventions.
Quanticate looks at the benefits of Functional Outsourcing and why a sponsor may consider using a FSP approach when outsourcing their clinical data
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.
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.
Quanticate examines the flexibility and power of the Global Statistical Test method that can provide further evidence of a treatment effect
Quanticate Podcast: An Introduction to Estimands. Our statisticians discuss what is Estimands, why it should be used and who it impacts
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...
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
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
An introduction to handling the issues of Missing Data in Clinical Trials which has changed the incorporation of missing data in study results.
Review the use of Multiple Imputation (MI) for handling missing data in clinical trials and ask yourself if it's really worth the effort.
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.
This blog describes the evolution of patient centricity in clinical trials and data collection, and the benefits of working in the biometric industry.
Can you easily create your own interactive dashboards in SAS? In this blog, Quanticate will explore whether SAS 4GL is all you need!
Quanticate outlines the in-depth problems of transposing data using PROC SQL and how tree traversal can be understood and implemented in SAS.
Quanticate explores what Machine Learning is and the three types of Machine Learning and real-life examples from the pharmaceutical industry.
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...
This blog post reviews the Advantages of Parallel Processing on the reporting and analysis of clinical trial data using SAS/Connect. Learn more with Quanticate's programming experts.
This blog post reviews re-randomization tests in equivalence trials and superiority trials and if, when and how to use them.
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
Different designs used in Phase 1 Clinical Trials suit certain study types to determine the safety, tolerability and pharmacokinetics (PK) of new compounds
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.
Our Statistical Consultants recently collaborated on an observational study to investigate the long-term relationship between fatigue and work disability in patients initiating treatment with etanercept for rheumatoid arthritis (RA) or anky...
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...
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...
This blog post gives a short overview of some of the key points presented at the BAYES 2018 Bayesian Biostatistics workshop on Bayesian approaches and historical controls in the analysis of randomized clinical trials.
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.
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...
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
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...
In this video our Senior Statisticians, Niccolo, presents an example of simulated data of Tipping Point Analysis in Multiple Imputation for Binary Missing Data
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)
The recent ICHGCP E6 (R2) addendum have resulted in the need for statistical programmers and biostatisticians to play an important role in risk-based monitoring
To assess what is happening in the real world, rather than using clinical trials to collect data, researchers may use data which come directly from the market.
A patient-reported outcome is a health outcome reported by the patient who experienced it, about how they feel in relation to a health condition and its therapy
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
Direct and Indirect pathways in observational studies are examined as we look at work productivity loss due to anxiety/depression in Inflammatory rheumatic diseases
This article looks at the evaluation of three methods assessing an early-phase equivalence in biosimilars for Rheumatoid Arthritis treatments.
As the majority of pharmaceutical companies and CROs ask for a MSc in Statistics when hiring statisticians we research if its really needed
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
Learn more about the recent trends in biosimilar development, the FDA guidance on biosimilars, and how clinical trial designs need to adapt accordingly
This blog explains how programmers within clinical research organizations work through simple requests to build a robust system using SAS, UNIX and experience.
A Member of the Quanticate Programming team writes about their opinions of the INTO statement in PROC SQL and its relation to SAS programmers.
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.
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
This blog reviews the processes, systems, tools and different coding dictionaries to perform medical coding in clinical data management
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
Learn about the cost considerations of outsourcing to a clinical research organization (CRO) compared to using internal resources for your clinical study
Examples and challenges of clinical trial performance metrics and the importance of defining robust metrics at the outset of a clinical study
This article discusses whether we should be integrating mobile health apps in clinical trials with references to recent case studies on wearables.
The future of Risk Based & Remote Monitoring, how globalisation has caused the FDA to advise risk mitigation and the fear of flouting regulatory compliance
Quanticate looks at the benefits of centralized clinical data services with a specialist data focused Clinical Research Organization or internally by a sponsor
A Quanticate blog on how well written Request For Proposals (RFPs) affect the selection of a Clinical Research Organization (CRO)
Quanticate demonstrates how to produce integrated summaries of safety and efficacy for regulatory submissions & the planning, creation & review of these reports
This blog by Quanticate examines the PROC Template statement and options within Clinical SAS Programming to create high quality graphics
This video 'Big Data in Clinical Trials' was presented by Nick Burch, CTO at Quanticate at the 4th Annual ECDM conference this year in Princeton, NJ.
This blog uses a survival analysis case study in clinical research and looks at delayed-entry models using PROC PHREG with SAS programming.
This blog explores myths of electronic data capture (EDC) systems in clinical data management and how it is not always expensive or time-consuming to set up
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
A Quanticate blog exploring the use of consumer-grade mHealth apps and wearables in clinical trials and the most recent regulations on mobile health
A survey result on the challenges of pharmacovigilance in early phase clinical trials and solutions to a lack of data, complicated patients and protocol design
Exploring the proportional odds assumption in analysis of clinical trials - A case study of the effect of aspirin in the treatment of stroke
The role of Statisticians within a pre-clinical study and how reducing errors can improve efficiency of the study by Quanticate.
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
Quanticate blogs on the different phases of clinical trials that are classified into 4 phases, with each potentially lasting for several years.
A Quanticate blog post exploring Analysis Data Model and ADaM Datasets, and how it is widely used in the submission of clinical trial information.
Quanticate looks at how companies can prepare for Big Data in the Pharmaceutical industry. Learn more.
This blog post showcases some of the most influential and important women in the history of science, medicine and mathematics.
Quanticate looks at Outcomes Research programming methods compared to traditional clinical trial programming and how to handle and process big data
17 Easy steps for compiling the appendices of a clinical study report to help clinical regulatory writers in the pharmaceutical industry.
Quanticate explores 4 efficiencies within Clinical Research Organizations (CROs) a sponsor should for short notice requests and to maximise a partnership
A Quanticate blog post that looks at Integrated Summary tips and best practices for regulatory submission
A Quanticate blog post highlighting guidelines for creating Custom or Non-Standard CDISC STDM Domains.
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.
A blog looking at the number of unique challenges that a medical writer might encounter while writing / managing patient / safety narrative projects.
Explanations and examples of 4 SAS tips to use in your day to day SAS Programming picked up from other programmers.
In this video Quanticate explores the creation of two ADaM datasets; ADPC and ADPP for Pharmacokinetic (PK) Analysis in clinical trials
Watch Ben Goldacre discuss Clinical Trial Transparency and 'AllTrials: Transparency is moving forwards, the pharmaceutical industry can benefit from doing the right thing'
Quanticate provides an overview of efficacy endpoints in oncology studies and the RECIST (Response Evaluation Criteria In Solid Tumours) method.
Bayesian statistics in clinical trials are becoming widely used, this blog explores utilizing a bayesian informative prior to reduce sample size.
How Big is Big Data in clinical trials? This article by Quanticate looks at exploring Big Data problems and just how much Big Data you may have.
A video of Kelci Miclaus from SAS JMP speaking at Clinical Data Live 2013, discussing Efficient Data Reviews and Quality in Clinical Trials.
Quanticate's latest blog explores practical applications of the Prentice-Wilcoxon Test for paired time-to-event data in clinical studies
A Quanticate blog on frequently asked questions on Clinical Study Design in the area of Bayesian Statistics and a focus on Phase 1 studies.
This Quanticate blog examines Challenges associated with reporting longitudinal observational data in a paediatric disease registry
This Quanticate blog looks at how within the pharmaceutical industry historical data can be used to inform future decisions in clinical trials
A Quanticate blog exploring The Black Triangle symbol ▼ and Additional Monitoring in the new Pharmacovigilance legislation.
Quanticate looks at how the statistical programming language R is often underrated within the Pharmaceutical Industry and the advantages of this appoach
Quanticate blogs on how randomization in clinical trials need not be complex - learn more.
Quanticate blogs about using Excel to write SAS code in the pharmaceutical industry which can make large scale amendments easier and quicker.
A slideshow by Quanticate focusing on the problems faced when dealing with Large SAS Datasets and ways to resolve this.
Quanticate gives an overview of Receiver Operating Characteristic (ROC) Curves in SAS PROC LOGISTIC
Quanticate's latest blog explores generating CDISC Compliant PK Workflows as part of Pharmacokinetic Analyses.
This recent blog by Quanticate examines Pharmacokinetic Considerations when comparing Biosimilarities
Quanticate looks at the SAS/Graph Annotation option with SAS Macros to allow the creation of multiple Forest Plots.
Quanticate explores the advantages of Data Centralization as well as Standardizing Data in Clinical Trials
A blog article by a member of Quanticate's Clinical Programming team exploring SAS Proc Transpose VS SAS Arrays within Clinical Programming
Using smartphones, tablets and other mobile devices for remote data capture in clinical trials and the impact this has on clinical development
When using SAS Business Intelligence in Clinical Trials, this infographic explores the process of how data arrives into the Web Report Studio
A Quanticate infographic exploring Quality Process Improvement and how we ensure our SOP Updates comply with regulatory changes.
This Quanticate blog post explores how centralized data in clinical trials can be used to take advantage of clinical study designs.
This Quanticate blog reviews the evolving standards of CDISC SDTM Therapeutic Area Domains
Quanticate looks at the challenges and rewards of working within a Clinical Research Organization.
As the European Medicines Agency (EMA) Finalises the first set of Good Pharmacovigilance Practices (GVP), are you ready for the New PV Legislation?
When embarking on a new outsourcing project, there are a few initial steps that must be taken to ensure a clinical research organization project runs smoothly
Following on from the previous blog posts on Integrated Summaries we can explore the use of CDISC SDTM for Cost and Quality efficient ISS/ISE studies
A Quanticate blog post on Survival Analysis, the use of the Cox Proportional Hazard Model and the lifetables in analyzing survival time.
Quanticate looks at SAS and WinNonlin as PK analysis tools. The pros and cons of either model in deciding how to handle your Pharmacokinetic data.
A Quanticate blog post that highlights 10 considerations when using offshore locations to support Clinical Trials.
A Quanticate blog post that reviews the "PSI Introduction to Industry Training Course” by a member of our Statistical Consultancy team.
Quanticate blogs on the importance of traceability of clinical information and challenges of meeting regulatory requirements with outsourced clinical data
A Quanticate blog article on managing multiple priorities in regulatory writing and medical writing tips to help manage projects efficiently.
Quanticate look at one part of Quality Assurance in Clinical Trials which is adhering to Good Clinical Practice (GCP)
What to consider and research when choosing a career as a regulatory writer in the clinical world by Quanticate.
Quanticate looks the use of Bayesian Study Design and Interim Analysis In Clinical Trials to improve efficiency in Drug Development.
Quanticates statistical consultancy team gives an introduction to biostatistics in clinical trials and the topics our company blog will cover.
Quanticate examines issues of Clinical SAS Programming when users experience problems working with large SAS datasets that are close to a 1GB in size