R Programming Datasets - Are they reliable & efficient for SAS Datasets?
In this blog we examine the use of R for programming datasets when performing statistical analysis in the pharmaceutical industry.
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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
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
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
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]](https://www.quanticate.com/hs-fs/hubfs/Real%20World%20Evidence%20Podcast-1.jpg?width=800&name=Real%20World%20Evidence%20Podcast-1.jpg)
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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Real-Time Oncology Review (RTOR): First Drug Approval
RTOR can reduce the approval time for Oncology Clinical Trials without affecting the safety and effectiveness of the treatment.
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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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Regulatory Writing – An Integral Part of Clinical Research
Regulatory Writing is used to create a variety of clinical documents. Such clinical trial documentation includes clinical study reports. Learn more
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Remote Monitoring During Clinical Trials - COVID-19 Update
Remote monitoring in clinical trials has never been so popular. This article explains a risk-based approach to remote monitoring and remote SDV
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A Guide to CDISC SDTM Standards, Theory and Application
This blog provides a background on CDISC SDTM Standards, and the advantages of SDTM's application
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A Guide to Adaptive Randomization based on a Patient's Characteristics
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.
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Get ready for Plain Language Summaries in Medical Writing
As industry regulators and study participants seek disclosure of information in clinical trials, medical writers are creating Plain Language Summaries
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Novel Coronavirus Disease-2019 (Covid-19) Statistics and Scientific Resources
Stay up to date with the latest statistics and scientific resources on the novel coronavirus (covid-19) pandemic
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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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Integration of CDISC ADaM Datasets for ISS/ISE Submissions
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.
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Why Consider Functional Outsourcing by a Functional Service Provider?
Quanticate looks at the benefits of Functional Outsourcing and why a sponsor may consider using a FSP approach when outsourcing their clinical data
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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
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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The Global Statistical Test for Multiple Endpoints Analysis
Quanticate examines the flexibility and power of the Global Statistical Test method that can provide further evidence of a treatment effect
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![An Introduction to Estimands [Podcast]](https://www.quanticate.com/hs-fs/hubfs/Episode%201%20An%20Introduction%20to%20Estimands%20Featured%20Image.jpg?width=800&name=Episode%201%20An%20Introduction%20to%20Estimands%20Featured%20Image.jpg)
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
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
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
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
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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Multiple Imputation for Handling Missing Data in Clinical Trials
Review the use of Multiple Imputation (MI) for handling missing data in clinical trials and ask yourself if it's really worth the effort.
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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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The Evolution of Patient Centricity in Clinical Trials and Data Collection
This blog describes the evolution of patient centricity in clinical trials and data collection, and the benefits of working in the biometric industry.
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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
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
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
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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The Advantages of Parallel Processing Clinical Data in SAS/Connect
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.
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Re-Randomization Tests in Equivalence Trials: Can We Still Use Them?
This blog post reviews re-randomization tests in equivalence trials and superiority trials and if, when and how to use them.
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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
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
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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![[Published Journal] Using Observational Studies to Investigate the Relationship Between Fatigue and Work Disability](https://www.quanticate.com/hs-fs/hubfs/observational%20studies%20fatigue%20work%20disability.jpg?width=800&name=observational%20studies%20fatigue%20work%20disability.jpg)
[Published Journal] Using Observational Studies to Investigate the Relationship Between Fatigue and Work Disability
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...
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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
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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Bayesian approaches to use historical data in the analysis of clinical trials
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.
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![[Video] Bayesian Methodology - How to Analyse Multiple Endpoints](https://www.quanticate.com/hs-fs/hubfs/Artwork%20Statistical%20Knowledge%20Share%20January.jpg?width=800&name=Artwork%20Statistical%20Knowledge%20Share%20January.jpg)
[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
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
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?
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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![[Video] Tipping Point Analysis in Multiple Imputation for Binary Missing Data](https://www.quanticate.com/hs-fs/hubfs/SKS%20-%20Niccolo%20-%20Featured%20image%20-%20FINAL.jpg?width=800&name=SKS%20-%20Niccolo%20-%20Featured%20image%20-%20FINAL.jpg)
[Video] Tipping Point Analysis in Multiple Imputation for Binary Missing Data
In this video our Senior Statisticians, Niccolo, presents an example of simulated data of Tipping Point Analysis in Multiple Imputation for Binary Missing Data
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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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Risk-Based Monitoring and the Need for Programmers and Statisticians
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
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The Problems (and solutions) of Real World Data in the Pharma Industry
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.
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Patient Reported Outcomes (PRO) to Support Medical Product Labeling Claims
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
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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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The Analysis of Direct and Indirect Pathways in Observational Studies
Direct and Indirect pathways in observational studies are examined as we look at work productivity loss due to anxiety/depression in Inflammatory rheumatic diseases
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Methods for assessing early-phase equivalence in Biosimilars
This article looks at the evaluation of three methods assessing an early-phase equivalence in biosimilars for Rheumatoid Arthritis treatments.
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Is a MSc in Statistics the ‘be-all and end-all’ to a career as a pharmaceutical statistician?
As the majority of pharmaceutical companies and CROs ask for a MSc in Statistics when hiring statisticians we research if its really needed
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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 Trend in Biosimilar Development and Recent FDA Guidance
Learn more about the recent trends in biosimilar development, the FDA guidance on biosimilars, and how clinical trial designs need to adapt accordingly
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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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The INTO Statement in PROC SQL to Create Macro Variables
A Member of the Quanticate Programming team writes about their opinions of the INTO statement in PROC SQL and its relation to SAS programmers.
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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
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
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?
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
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 Importance of Defining Clinical Trial Performance Metrics
Examples and challenges of clinical trial performance metrics and the importance of defining robust metrics at the outset of a clinical study
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Should We Be Integrating Mobile Health Apps in Clinical Trials?
This article discusses whether we should be integrating mobile health apps in clinical trials with references to recent case studies on wearables.
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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
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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How Well Written Proposals Affect Clinical Research Organization Selection
A Quanticate blog on how well written Request For Proposals (RFPs) affect the selection of a Clinical Research Organization (CRO)
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Integrated Summaries of Safety & Efficacy for Regulatory Submissions
Quanticate demonstrates how to produce integrated summaries of safety and efficacy for regulatory submissions & the planning, creation & review of these reports
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Creating High Quality Graphics in Clinical SAS Programming
This blog by Quanticate examines the PROC Template statement and options within Clinical SAS Programming to create high quality graphics
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![Nick Burch Discusses Big Data in Clinical Trials [Video]](https://www.quanticate.com/hs-fs/hubfs/Nick%20Burch%20Big%20Data-1.jpg?width=800&name=Nick%20Burch%20Big%20Data-1.jpg)
Nick Burch Discusses Big Data in Clinical Trials [Video]
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.
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Delayed-entry models using PROC PHREG in Survival Analysis
This blog uses a survival analysis case study in clinical research and looks at delayed-entry models using PROC PHREG with SAS programming.
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Electronic Data Capture Systems In Clinical Data Management: The myths and the reality
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
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![The Rise of Risk Based Monitoring [Infographic]](https://www.quanticate.com/hs-fs/hubfs/The_Rise_of_Risk_Based_Monitoring_in_Clinical_Trials_Infographic-1.png?width=800&name=The_Rise_of_Risk_Based_Monitoring_in_Clinical_Trials_Infographic-1.png)
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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mHealth Apps and Wearables in Clinical Trials to Consider
A Quanticate blog exploring the use of consumer-grade mHealth apps and wearables in clinical trials and the most recent regulations on mobile health
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Is Lack of Data the Biggest Challenge for Early Phase Pharmacovigilance?
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
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Understanding the Proportional Odds Assumption in Clinical Trials
Exploring the proportional odds assumption in analysis of clinical trials - A case study of the effect of aspirin in the treatment of stroke
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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
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
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
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
Quanticate looks at how companies can prepare for Big Data in the Pharmaceutical industry. Learn more.
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Celebrating Women in Science, Medicine and Mathematics
This blog post showcases some of the most influential and important women in the history of science, medicine and mathematics.
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Outcomes Research Programming vs Traditional Clinical Trial Programming
Quanticate looks at Outcomes Research programming methods compared to traditional clinical trial programming and how to handle and process big data
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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
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
A Quanticate blog post that looks at Integrated Summary tips and best practices for regulatory submission
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Creating Custom or Non-Standard CDISC SDTM Domains
A Quanticate blog post highlighting guidelines for creating Custom or Non-Standard CDISC STDM Domains.
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![Conducting Randomization in Clinical Trials [VIDEO]](https://www.quanticate.com/hs-fs/hubfs/Quanticate%20Logo%20-%20Email%20Signature.png?width=800&name=Quanticate%20Logo%20-%20Email%20Signature.png)
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
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]](https://www.quanticate.com/hs-fs/hubfs/SAS_Tips.jpg?width=800&name=SAS_Tips.jpg)
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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![The Creation of ADaM Datasets for Pharmacokinetic (PK) Analysis [Video]](https://www.quanticate.com/hs-fs/hubfs/Live%20Webinar%20Featured%20Image.jpg?width=800&name=Live%20Webinar%20Featured%20Image.jpg)
The Creation of ADaM Datasets for Pharmacokinetic (PK) Analysis [Video]
In this video Quanticate explores the creation of two ADaM datasets; ADPC and ADPP for Pharmacokinetic (PK) Analysis in clinical trials
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!['Clinical Trial Transparency and ALLTrials' by Ben Goldacre [Video]](https://www.quanticate.com/hs-fs/hub/22135/file-2523594494-jpg/Ben_Goldacre_Clinical_Data_Transparency.jpg?width=800&name=Ben_Goldacre_Clinical_Data_Transparency.jpg)
'Clinical Trial Transparency and ALLTrials' by Ben Goldacre [Video]
Watch Ben Goldacre discuss Clinical Trial Transparency and 'AllTrials: Transparency is moving forwards, the pharmaceutical industry can benefit from doing the right thing'
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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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Utilizing a Bayesian Informative Prior to Reduce Sample Size in Clinical Trials
Bayesian statistics in clinical trials are becoming widely used, this blog explores utilizing a bayesian informative prior to reduce sample size.
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How Big is Big Data in Clinical Trials – Tall, Grande, Venti Data?
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.
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![Efficient Data Reviews and Quality in Clinical Trials [Video]](https://www.quanticate.com/hs-fs/hubfs/Efficiency%20and%20Quality%20in%20Clinical%20Trials.jpg?width=800&name=Efficiency%20and%20Quality%20in%20Clinical%20Trials.jpg)
Efficient Data Reviews and Quality in Clinical Trials [Video]
A video of Kelci Miclaus from SAS JMP speaking at Clinical Data Live 2013, discussing Efficient Data Reviews and Quality in Clinical Trials.
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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
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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Longitudinal Observational Data in a Paediatric Disease Registry
This Quanticate blog examines Challenges associated with reporting longitudinal observational data in a paediatric disease registry
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Using Historical Data to Inform Future Decisions in Clinical Trials
This Quanticate blog looks at how within the pharmaceutical industry historical data can be used to inform future decisions in clinical trials
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Pharmacovigilance - The Black Triangle and Additional Monitoring
A Quanticate blog exploring The Black Triangle symbol ▼ and Additional Monitoring in the new Pharmacovigilance legislation.
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Using the Statistical Programming Language R in the Pharma Industry
Quanticate looks at how the statistical programming language R is often underrated within the Pharmaceutical Industry and the advantages of this appoach
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Complex Randomization in Clinical Trials Need Not Be Complex
Quanticate blogs on how randomization in clinical trials need not be complex - learn more.
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Using Microsoft Excel to write SAS code in Clinical Trials
Quanticate blogs about using Excel to write SAS code in the pharmaceutical industry which can make large scale amendments easier and quicker.
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How to Deal with Large SAS Datasets in Clinical Trials
A slideshow by Quanticate focusing on the problems faced when dealing with Large SAS Datasets and ways to resolve this.
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Overview of Receiver Operating Characteristic (ROC) Curves in SAS
Quanticate gives an overview of Receiver Operating Characteristic (ROC) Curves in SAS PROC LOGISTIC
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Performing CDISC Compliant Pharmacokinetic Analyses
Quanticate's latest blog explores generating CDISC Compliant PK Workflows as part of Pharmacokinetic Analyses.
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Pharmacokinetic Considerations of Biosimilars
This recent blog by Quanticate examines Pharmacokinetic Considerations when comparing Biosimilarities
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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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14 Advantages of Data Centralization and Standardization in Clinical Trials
Quanticate explores the advantages of Data Centralization as well as Standardizing Data in Clinical Trials
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SAS Proc Transpose VS SAS Arrays in Clinical Programming
A blog article by a member of Quanticate's Clinical Programming team exploring SAS Proc Transpose VS SAS Arrays within Clinical Programming
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Remote Data Capture in Clinical Trials through Smartphones, Tablets and other Mobile Devices
Using smartphones, tablets and other mobile devices for remote data capture in clinical trials and the impact this has on clinical development
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SAS Business Intelligence - A Perceptive Vision in Clinical Trials
When using SAS Business Intelligence in Clinical Trials, this infographic explores the process of how data arrives into the Web Report Studio
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![Quality Process Improvements and SOP Updates [Infographic]](https://www.quanticate.com/hs-fs/hub/22135/file-13431533-png/images/quality_process_improvement1-resized-600.png?width=800&name=quality_process_improvement1-resized-600.png)
Quality Process Improvements and SOP Updates [Infographic]
A Quanticate infographic exploring Quality Process Improvement and how we ensure our SOP Updates comply with regulatory changes.
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How a Centralized Approach to Data Impacts Clinical Study Design
This Quanticate blog post explores how centralized data in clinical trials can be used to take advantage of clinical study designs.
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CDISC SDTM Therapeutic Area Domains - a Rapidly Evolving Standard?
This Quanticate blog reviews the evolving standards of CDISC SDTM Therapeutic Area Domains
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Challenges and Rewards of Working in a Clinical Research Organization
Quanticate looks at the challenges and rewards of working within a Clinical Research Organization.
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Are you ready for the New Pharmacovigilance Legislation?
As the European Medicines Agency (EMA) Finalises the first set of Good Pharmacovigilance Practices (GVP), are you ready for the New PV Legislation?
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Making a Clinical Research Organization Project Run Smoothly
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
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Using CDISC SDTM to Improve Cost and Quality in Integrated Summaries
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
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Survival Analysis: Lifetables and Cox Proportional Hazard Model
A Quanticate blog post on Survival Analysis, the use of the Cox Proportional Hazard Model and the lifetables in analyzing survival time.
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PK data analysis and reporting: SAS or Phoenix WinNonlin?
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.
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10 Considerations of Offshore Locations to Support Clinical Trials
A Quanticate blog post that highlights 10 considerations when using offshore locations to support Clinical Trials.
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An Introduction to Industry Training Course Review - Statisticians in the Pharmaceutical Industry
A Quanticate blog post that reviews the "PSI Introduction to Industry Training Course” by a member of our Statistical Consultancy team.
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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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Medical Writing Tips For Managing Multiple Priorities
A Quanticate blog article on managing multiple priorities in regulatory writing and medical writing tips to help manage projects efficiently.
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Quality Assurance in Clinical Trials – An Introduction to GCP
Quanticate look at one part of Quality Assurance in Clinical Trials which is adhering to Good Clinical Practice (GCP)
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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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Bayesian Study Design & Interim Analysis In Clinical Trials
Quanticate looks the use of Bayesian Study Design and Interim Analysis In Clinical Trials to improve efficiency in Drug Development.
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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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Clinical SAS Programming – Working Efficiently with Large Datasets
Quanticate examines issues of Clinical SAS Programming when users experience problems working with large SAS datasets that are close to a 1GB in size
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