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The blog

DO Loops in SAS: Iterative, Conditional, and PROC DS2 Multithreading

By Clinical Programming Team
May 20, 2025
Learn SAS DO loops from Base to PROC DS2: iterative, list-based, conditional, nested loops, and multithreading for faster data processing.
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An Introduction To Biostatistics In Clinical Trials

By Statistical Consultancy Team
May 16, 2025
Understand how biostatistics drives reliable results in clinical trials, ensuring data integrity, patient safety, and regulatory confidence.
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Human Gene Therapy Clinical Trials for Hemophilia A & B

By Statistical Consultancy Team
May 9, 2025
Discover the latest hemophilia gene therapy clinical trials, FDA-approved treatments, key challenges, and future directions in durable, single-dose care.
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FDA's Project Optimus: What You Need to Know

By Statistical Consultancy Team
May 2, 2025
Explore the FDA's Project Optimus, an initiative aimed at optimising oncology drug dosing to enhance efficacy and minimise toxicity in cancer treatments.
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What is Biometrics in Clinical Trials?

By Commercial Team
May 1, 2025
Discover how biometrics in clinical trials drives personalised medicine, from genetic insights to tailored treatments.
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The Role of Clinical Trial Data Visualisation in Modern Drug Development

By Clinical Programming Team
April 29, 2025
Explore how clinical trial data visualisation enhances oversight, accelerates timelines, and drives smarter decisions.
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First Steps in Laboratory Dataset Handling: From SAS to R

By Clinical Programming Team
April 24, 2025
Streamline lab data workflows with tips for SAS and R, covering everything from standardisation, macros, and regulatory readiness.
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What is a Late Phase CRO? Understanding Their Role in Drug Development

By Commercial Team
April 17, 2025
Learn what a late-phase CRO is, their role in Phase IIIb/IV trials, and how they support real-world evidence and long-term safety monitoring.
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Understanding CDISC Standards in Clinical Research: A Complete Guide

By Clinical Programming Team
April 15, 2025
Discover how CDISC standards support reliable clinical trial data, real-world evidence, and harmonised global submissions.
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SAS Proc Transpose In Clinical Trial Programming

By Clinical Programming Team
April 11, 2025
Explore how SAS PROC TRANSPOSE is used in clinical trial programming to reshape data for analysis and reporting.
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The Importance of Quality Tolerance Limits (QTLs) in Clinical Trials

By Clinical Data Management Team
April 9, 2025
Discover the role of QTLs in clinical trials and how they enhance oversight, safeguard patient safety, and meet ICH E6(R3) compliance standards.
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What is a Full-Service CRO? A Comprehensive Guide

By Commercial Team
March 5, 2025
What is a full-service CRO? Learn how these organisations support clinical trials with end-to-end services, streamlining research and regulatory success.
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The Global Statistical Test for Multiple Endpoints Analysis

By Statistical Consultancy Team
February 28, 2025
Learn how the Global Statistical Test (GST) enhances clinical trials by analysing multiple endpoints while controlling Type-I error rates.
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The Use of Wearables in Clinical Trials

By Clinical Data Management Team
February 27, 2025
Discover how wearables in clinical trials enhance data accuracy, patient engagement, and decentralised research for more efficient study outcomes.
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A Guide to Complex Innovative Trial Designs

By Statistical Consultancy Team
February 25, 2025
Explore Complex Innovative Trial Designs (CIDs) in clinical research: adaptive, Bayesian, biomarker-driven methods, case studies, challenges and more
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Data Anonymisation in Clinical Trials

By Clinical Programming Team
February 20, 2025
Protect patient privacy with effective data anonymisation in clinical trials. Learn key techniques to balance compliance, security, and data utility.
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The Role of Reconciliation in Clinical Data Management

By Clinical Data Management Team
February 18, 2025
Ensure accuracy with reconciliation in clinical data management. Discover best practices for data integrity, automation, and compliance in clinical trials.
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BIMO Listings: A Complete Guide to FDA Compliance and Clinical Trial Success

By Clinical Programming Team
February 14, 2025
Learn how BIMO listings help sponsors and CROs navigate FDA inspections, ensuring clinical trial compliance and data accuracy.
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The Assumption of Proportional Odds in Clinical Trials

By Statistical Consultancy Team
February 7, 2025
Learn about the proportional odds assumption in clinical trials, its importance in ordinal regression, and key considerations for statistical analysis.
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The Role of CRO Outsourcing in Clinical Research

By Commercial Team
February 3, 2025
Explore how CRO outsourcing supports efficient clinical research through strategic models, cost control, and evolving technologies in drug development.
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The Ultimate Guide to Electronic Data Capture for Clinical Trials

By Clinical Data Management Team
January 31, 2025
Discover how EDC systems enhance clinical trials with efficient data collection, real-time validation, robust security, and streamlined workflows.
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Key Considerations in Implementing FSP Models

By Commercial Team
January 22, 2025
Explore key factors for implementing FSP models to boost efficiency, ensure compliance, and streamline operations in sponsor-vendor strategic partnerships.
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The Fundamentals of Clinical Trial Data Integration

By Clinical Data Management Team
January 10, 2025
Streamline clinical trial data integration with automation and real-time insights. Learn how to enhance accuracy, compliance, and decision-making.
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Top 10 CROs Shaping Clinical Trials in 2025

By Commercial Team
January 3, 2025
Explore the top 10 CROs to watch in 2025 and get simple tips to pick the right partner for your clinical trials.
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A Guide to Adaptive Randomisation in Clinical Trials

By Statistical Consultancy Team
December 16, 2024
An Adaptive Randomisation method based on a Patient's Characteristics used in phase 2 and phase 3 clinical trials that focuses on personalising medication for rare diseases and adaptive trial design.
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Methodologies for Missing Data in Clinical Trials

By Statistical Consultancy Team
December 9, 2024
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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Multi-Omics and its Application in Personalised Medicine Studies

By Statistical Consultancy Team
December 5, 2024
Explore how multi-omics transforms personalised medicine, integrating genomics, proteomics, and metabolomics to advance precision healthcare.
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A Guide to Randomisation in Clinical Trials

By Statistical Consultancy Team
December 3, 2024
Discover the essentials of randomisation in clinical trials, covering methods, benefits, and best practices for robust and unbiased research.
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Efficacy Endpoints in Oncology Clinical Trials

By Clinical Programming Team
November 22, 2024
A guide to efficacy endpoints in oncology clinical trials and the RECIST (Response Evaluation Criteria In Solid Tumours) method.
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The Different Phases of Clinical Trials

By Statistical Consultancy Team
October 28, 2024
Learn about all the different phases of clinical trials that are classified into 4 phases, including a phase 0, and their study designs and methodologies.
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The Advantages of Parallel Processing Clinical Data in SAS/Connect

By Clinical Programming Team
October 15, 2024
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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Medical Coding in Clinical Data Management

By Clinical Data Management Team
September 30, 2024
This blog reviews the processes, systems, tools and different coding dictionaries to perform medical coding in clinical data management
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Insights into Therapeutic Areas in Clinical Research

By Commercial Team
September 27, 2024
Explore the complexities and advancements in various therapeutic areas within clinical research, driving medical innovation and enhancing patient care globally.
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ACR Response Criteria in Rheumatoid Arthritis Clinical Trials

By Statistical Consultancy Team
September 25, 2024
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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SAS Tips and Tricks -  An Overview of Good Programming Practices

By Clinical Programming Team
September 23, 2024
Optimise your SAS programming with our expert tips on efficient coding practices, handling large datasets, & leveraging special characters & shortcuts for streamlined workflows.
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How Clinical Trial Trends are Redefining Drug Development

By Commercial Team
September 13, 2024
Explore key trends in clinical trials for 2024-2025, including patient-centric trials, AI integration, real-world evidence, novel trial designs, and sustainability efforts.
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SAS Quality Control in Clinical Trials – Creating Batch Programs for QC

By Clinical Programming Team
September 11, 2024
This blog explores the importance of SAS quality control in clinical trial programming and an example using batch programs to QC using SAS UNIX.
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Health Economics and Outcomes Research (HEOR) Programming

By Clinical Programming Team
September 10, 2024
Discover what Health Economics and Outcomes Research (HEOR) is and how it’s applied in programming to analyse healthcare data and improve patient outcomes.
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Can AI or ML Help You Design a Better Clinical Trial?

By Statistical Consultancy Team
September 6, 2024
Discover how AI & ML are optimising clinical trial design with advanced predictive modeling, NLP, retrospective analysis, & adaptive trial strategies for better patient outcomes.
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Using R Programming for Clinical Trial Data Analysis

By Clinical Programming Team
September 4, 2024
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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How to Understand and Create a Statistical Analysis Plan (SAP)

By Statistical Consultancy Team
September 2, 2024
Learn how to create a Statistical Analysis Plan (SAP) for clinical trials. Understand everything from the key documents to regulatory guidelines.
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Understanding the Database Lock Process in Clinical Trials

By Clinical Data Management Team
August 29, 2024
Discover the essential steps & best practices for a smooth Database Lock Process to ensure data integrity & successful regulatory submissions.
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How to Perform ISS and ISE Analysis Using SAS

By Clinical Programming Team
August 28, 2024
Learn how to perform Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) analysis using SAS for your regulatory submission.
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Everything You Need to Know About BOIN Design in Clinical Trials

By Statistical Consultancy Team
August 23, 2024
Bayesian Optimal Interval (BOIN) design are growing in popularity due to their statistical robustness, practical applicability and simplicity. Learn more.
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4 Ways to Improve Clinical Data Quality & Control in Modern Trials

By Clinical Data Management Team
August 20, 2024
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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Navigating Audit Trail Review Regulations in Clinical Research

By Clinical Data Management Team
August 19, 2024
Ensure compliance and data integrity in clinical trials with a thorough audit trail review (ATR) as we identify the key considerations for you to follow.
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Patient Centricity in Clinical Trials

By Clinical Data Management Team
August 15, 2024
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 PROC SQL: Creating Macro Variables with the INTO Statement & Other Applications

By Clinical Programming Team
August 8, 2024
Explore PROC SQL's INTO statement for creating macro variables & enhancing data manipulation in SAS programming to streamline data analysis processes.
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Leveraging Automation to Streamline Clinical Data Management

By Clinical Data Management Team
August 6, 2024
Uncover the key benefits, best practices and notable tech solutions for automation, and how it is streamlining processes and increasing efficiency in Clinical Data Management.
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A Guide to Real-World Evidence in Clinical Trials

By Clinical Programming Team
August 2, 2024
Explore how Real-World Evidence is optimising clinical drug development by leveraging Real-World Data for improved patient outcomes & streamlined research processes.
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A Guide to CDISC SDTM Standards and Domains

By Clinical Programming Team
July 29, 2024
This blog provides a background on CDISC SDTM Standards, and the advantages of SDTM's application
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Data Validation in Clinical Data Management

By Clinical Data Management Team
July 26, 2024
Explore the importance of data validation in clinical trials, from key components & processes to modern techniques & regulatory compliance for reliable outcomes in clinical data management.
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The Role of Data Monitoring Committees (DMC) in Clinical Trials

By Statistical Consultancy Team
July 22, 2024
Explore the crucial role Data Monitoring Committees play in clinical trials, ensuring patient safety, data integrity, and effective study oversight.
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The Effects the ICH E6(R3) Updates Will Have on Good Clinical Practice

By Quality Assurance Team
July 5, 2024
Discover how the ICH E6(R3) updates will impact Good Clinical Practice, from enhanced ethical standards & patient-centricity to a risk-balanced approach.
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A Guide to CDISC ADaM Standards in 2024

By Clinical Programming Team
June 26, 2024
Your guide of everything you need to know about Analysis Data Model (ADaM) standards and datasets in 2024 to ensure a smooth regulatory submission.
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What is Clinical Data Management?

By Clinical Data Management Team
June 13, 2024
Discover how Clinical Data Management ensures data integrity and regulatory compliance in clinical trials, and deep dive into the roles, stages, and essential skills required.
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Risk-Based Quality Management in Clinical Data Management

By Clinical Data Management Team
June 7, 2024
Discover how Risk-Based Quality Management (RBQM) optimizes clinical data management for improved safety, efficiency, and regulatory compliance in clinical trials
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The ALCOA+ Principles for Data Integrity In Clinical Trials

By Clinical Data Management Team
May 30, 2024
The principles outlined in ALCOA and ALCOA+ support data integrity and compliance in clinical trials to ensure a successful regulatory submission.
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A Guide to Creating and Developing a Clinical Data Management Plan

By Clinical Data Management Team
May 24, 2024
Create an effective Clinical Data Management Plan with our guide. Quanticate offers expert support for Phases I-IV & device trials. Contact us for tailored solutions.
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CDASH Standards and Conformance in Clinical Data Management

By Clinical Data Management Team
May 16, 2024
Conformance to CDASH is critical in clinical research and data management. Explore common questions and guidance on CDISC's CDASH standards in our latest blog.
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Managing Data Challenges in Clinical Studies with a Data Safety Monitoring Board

By Clinical Data Management Team
May 10, 2024
Explore the essential functions of a Data Safety Monitoring Board (DSMB) and the crucial role data management plays in supporting its activities.
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How CDISC SDTM Improves Cost & Quality in ISS/ISE in 2024

By Clinical Programming Team
May 8, 2024
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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Advancing Clinical Data Management into a New Era

By Clinical Data Management Team
May 2, 2024
Explore how the fusion of AI, machine learning, & unified platforms integrated systems like Veeva CDB is revolutionising data management in clinical trials.
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Everything You Need to Know About Virtual Clinical Trials

By Statistical Consultancy Team
April 12, 2024
Discover the benefits and challenges of virtual trials, & how leveraging digital technology could enhance efficiency and accessibility in clinical studies.
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CRF Design for Oncology Trials

By Clinical Data Management Team
April 5, 2024
Explore key considerations in Case Report Form (CRF) design for oncology clinical trials, highlighting the unique challenges in this therapeutic area.
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5 Key Steps of eCRF Design in Clinical Trials

By Clinical Data Management Team
March 19, 2024
Make sure you follow these 5 steps of eCRF design to ensure the appropriate data is collected and can be used for the analysis of your clinical study.
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Rescue Studies – How to Reassess, Revise & Recover Your Clinical Trial

By Statistical Consultancy Team
March 11, 2024
This guide demonstrates how to reassess, revise & recover your clinical trial successfully with a rescue study, & the benefits of choosing the right CRO.
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A Guide to Integrated Summaries of Safety & Effectiveness (ISS & ISE)

By Statistical Consultancy Team
March 5, 2024
This guide demonstrates how to plan, review, produce successful integrated summaries of safety and effectiveness (ISS & ISE) for regulatory submissions
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Real-Time Oncology Review (RTOR): First Drug Approval

By Statistical Consultancy Team
January 24, 2024
RTOR can reduce the approval time for Oncology Clinical Trials without affecting the safety and effectiveness of the treatment.
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The What, Why and How of Adaptive Clinical Trials

By Statistical Consultancy Team
January 10, 2024
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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Dose Expansion Phases in Oncology Trials: A Guide to RP2D

By Statistical Consultancy Team
October 6, 2023
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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A Guide to Phase 1 Clinical Trial Designs

By Statistical Consultancy Team
September 18, 2023
Discover the different designs used in Phase 1 Clinical Trials that suit certain study types to determine the safety, tolerability and PK of new compounds.
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6 Key Clinical Data Management Practices For Biotechnology Trials

By Clinical Data Management Team
September 13, 2023
Clinical trials for biotechnology companies can be complex. Discover six key factors at the clinical data management stage to improve your trial.
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Creating your own interactive dashboards in SAS

By Clinical Programming Team
August 3, 2023
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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ICH GCP E6 Addendum R2 - What do you need to know?

By Commercial Team
May 30, 2023
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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Everything You Need to Know about Pinnacle 21

By Clinical Programming Team
May 10, 2023
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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What is a CRO?

By Commercial Team
August 11, 2022
Explore the crucial role of Contract Research Organisations (CROs) in drug development, from clinical trials to regulatory compliance, and their impact on the healthcare industry.
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A Guide to Estimands in Clinical Trials

By Statistical Consultancy Team
February 1, 2022
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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R Programming Datasets - Are they reliable & efficient for SAS Datasets?

By Clinical Programming Team
August 27, 2021
In this blog we examine the use of R for programming datasets when performing statistical analysis in the pharmaceutical industry.
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Respiratory Clinical Trials to Support COVID-19 Survivors

By Statistical Consultancy Team
June 16, 2020
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

By Medical Writing Team
May 21, 2020
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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A Guide to Remote Monitoring in Clinical Trials

By Commercial Team
May 3, 2020
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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Get ready for Plain Language Summaries in Medical Writing

By Medical Writing Team
March 27, 2020
As industry regulators and study participants seek disclosure of information in clinical trials, medical writers are creating Plain Language Summaries
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Subject: Sending Emails using VBA and SAS

By Clinical Programming Team
July 22, 2019
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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Machine Learning in the Pharmaceutical Industry

By Clinical Programming Team
May 21, 2019
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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Re-Randomization Tests in Equivalence Trials: Can We Still Use Them?

By Statistical Consultancy Team
November 29, 2018
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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Why do a 3rd of Regulatory Submissions fail the Technical Rejection Criteria?

By Clinical Programming Team
August 6, 2018
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
July 31, 2018
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

By Statistical Consultancy Team
July 20, 2018
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

By Statistical Consultancy Team
July 10, 2018
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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What Defines Quality in Medical Writing?

By Medical Writing Team
March 22, 2018
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

By Statistical Consultancy Team
March 2, 2018
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

By Pharmacovigilance Team
February 15, 2018
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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The Problems (and solutions) of Real World Data in the Pharma Industry

By Clinical Programming Team
January 9, 2018
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

By Statistical Consultancy Team
December 11, 2017
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?

By Pharmacovigilance Team
December 4, 2017
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

By Statistical Consultancy Team
October 17, 2017
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

By Statistical Consultancy Team
September 25, 2017
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?

By Statistical Consultancy Team
September 14, 2017
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

By Statistical Consultancy Team
September 5, 2017
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

By Statistical Consultancy Team
June 27, 2017
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 History of Pharmacovigilance Infographic

By Pharmacovigilance Team
March 27, 2017
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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The Importance of Defining Clinical Trial Performance Metrics

By Commercial Team
January 24, 2017
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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A Guide to the Benefits of Centralized Clinical Data

By Commercial Team
November 18, 2016
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

By Commercial Team
October 28, 2016
A Quanticate blog on how well written Request For Proposals (RFPs) affect the selection of a Clinical Research Organization (CRO)
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Creating High Quality Graphics in Clinical SAS Programming

By Statistical Consultancy Team
October 11, 2016
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]

By Nick Burch
September 27, 2016
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

By Statistical Consultancy Team
September 16, 2016
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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Is Lack of Data the Biggest Challenge for Early Phase Pharmacovigilance?

By Pharmacovigilance Team
June 23, 2016
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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The Role of a Statistician In a Pre-Clinical Study

By Statistical Consultancy Team
May 13, 2016
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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Preparing for Big Data in Pharma

By Nick Burch
March 17, 2016
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

By Commercial Team
March 8, 2016
This blog post showcases some of the most influential and important women in the history of science, medicine and mathematics.
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Compiling the Appendices for a Clinical Study Report

By Medical Writing Team
February 19, 2016
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
February 5, 2016
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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The Challenges of Writing Patient / Safety Narratives

By Medical Writing Team
November 24, 2015
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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The Creation of ADaM Datasets for Pharmacokinetic (PK) Analysis [Video]

By Clinical Programming Team
March 26, 2015
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]

By Statistical Consultancy Team
February 23, 2015
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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Utilizing a Bayesian Informative Prior to Reduce Sample Size in Clinical Trials

By Statistical Consultancy Team
November 13, 2014
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?

By Nick Burch
August 29, 2014
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]

By Statistical Consultancy Team
June 13, 2014
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

By Statistical Consultancy Team
May 16, 2014
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
January 31, 2014
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

By Statistical Consultancy Team
January 21, 2014
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

By Statistical Consultancy Team
November 15, 2013
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

By Pharmacovigilance Team
November 8, 2013
A Quanticate blog exploring The Black Triangle symbol ▼ and Additional Monitoring in the new Pharmacovigilance legislation.
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Performing CDISC Compliant Pharmacokinetic Analyses

By Statistical Consultancy Team
July 26, 2013
Quanticate's latest blog explores generating CDISC Compliant PK Workflows as part of Pharmacokinetic Analyses.
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Pharmacokinetic Considerations of Biosimilars

By Statistical Consultancy Team
July 19, 2013
This recent blog by Quanticate examines Pharmacokinetic Considerations when comparing Biosimilarities
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Multiple Forest Plots and the use of SAS Macros

By Clinical Programming Team
July 5, 2013
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

By Clinical Programming Team
June 18, 2013
Quanticate explores the advantages of Data Centralization as well as Standardizing Data in Clinical Trials
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SAS Business Intelligence - A Perceptive Vision in Clinical Trials

By Clinical Programming Team
January 30, 2013
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]

By Quality Assurance Team
November 30, 2012
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

By Statistical Consultancy Team
November 9, 2012
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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Are you ready for the New Pharmacovigilance Legislation?

By Pharmacovigilance Team
June 29, 2012
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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Survival Analysis: Lifetables and Cox Proportional Hazard Model

By Clinical Programming Team
April 13, 2012
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?

By Statistical Consultancy Team
February 2, 2012
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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Traceability - Where is Your Clinical Information?

By Commercial Team
September 28, 2011
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

By Medical Writing Team
June 9, 2011
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

By Quality Assurance Team
May 18, 2011
Quanticate look at one part of Quality Assurance in Clinical Trials which is adhering to Good Clinical Practice (GCP)
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Bayesian Study Design & Interim Analysis In Clinical Trials

By Statistical Consultancy Team
April 6, 2011
Quanticate looks the use of Bayesian Study Design and Interim Analysis In Clinical Trials to improve efficiency in Drug Development.
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