Explore the FDA's Project Optimus, an initiative aimed at optimising oncology drug dosing to enhance efficacy and minimise toxicity in cancer treatments.
What is a full-service CRO? Learn how these organisations support clinical trials with end-to-end services, streamlining research and regulatory success.
Ensure accuracy with reconciliation in clinical data management. Discover best practices for data integrity, automation, and compliance in clinical trials.
Learn about the proportional odds assumption in clinical trials, its importance in ordinal regression, and key considerations for statistical analysis.
Explore how CRO outsourcing supports efficient clinical research through strategic models, cost control, and evolving technologies in drug development.
Explore key factors for implementing FSP models to boost efficiency, ensure compliance, and streamline operations in sponsor-vendor strategic partnerships.
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.
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.
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.
Explore the complexities and advancements in various therapeutic areas within clinical research, driving medical innovation and enhancing patient care globally.
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...
Optimise your SAS programming with our expert tips on efficient coding practices, handling large datasets, & leveraging special characters & shortcuts for streamlined workflows.
Explore key trends in clinical trials for 2024-2025, including patient-centric trials, AI integration, real-world evidence, novel trial designs, and sustainability efforts.
Discover what Health Economics and Outcomes Research (HEOR) is and how it’s applied in programming to analyse healthcare data and improve patient outcomes.
Discover how AI & ML are optimising clinical trial design with advanced predictive modeling, NLP, retrospective analysis, & adaptive trial strategies for better patient outcomes.
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.
Bayesian Optimal Interval (BOIN) design are growing in popularity due to their statistical robustness, practical applicability and simplicity. Learn more.
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.
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.
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.
Explore how Real-World Evidence is optimising clinical drug development by leveraging Real-World Data for improved patient outcomes & streamlined research processes.
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.
Discover how the ICH E6(R3) updates will impact Good Clinical Practice, from enhanced ethical standards & patient-centricity to a risk-balanced approach.
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.
Discover how Risk-Based Quality Management (RBQM) optimizes clinical data management for improved safety, efficiency, and regulatory compliance in clinical trials
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.
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.
Explore how the fusion of AI, machine learning, & unified platforms integrated systems like Veeva CDB is revolutionising data management in clinical trials.
Discover the benefits and challenges of virtual trials, & how leveraging digital technology could enhance efficiency and accessibility in clinical studies.
This guide demonstrates how to reassess, revise & recover your clinical trial successfully with a rescue study, & the benefits of choosing the right CRO.
This guide demonstrates how to plan, review, produce successful integrated summaries of safety and effectiveness (ISS & ISE) for regulatory submissions
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 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
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.
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
Pinnacle 21 has evolved and knowledge of its software has become an indispensable skill of every statistical programmer who works with CDISC standards.
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.
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
Patients who survive COVID‑19 may suffer lasting lung damage. This blog explores Pulmonary fibrosis in COVID-19 and Respiratory Clinical Trial Designs.
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.
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)
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
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
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
Quanticate looks at the benefits of centralized clinical data services with a specialist data focused Clinical Research Organization or internally by a sponsor
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
Quanticate explores 4 efficiencies within Clinical Research Organizations (CROs) a sponsor should for short notice requests and to maximise a partnership
Watch Ben Goldacre discuss Clinical Trial Transparency and 'AllTrials: Transparency is moving forwards, the pharmaceutical industry can benefit from doing the right thing'
Quanticate blogs on the importance of traceability of clinical information and challenges of meeting regulatory requirements with outsourced clinical data