Enhance your clinical trial design with our strategic consulting services, featuring adaptive trial models and comprehensive regulatory guidance to ensure innovative, compliant, and successful trial outcomes.
Learn more
Experience the future of flexible strategic partnerships with Analytics on Demand, providing adaptive and innovative solutions that transcend traditional models to achieve unparalleled operational excellence.
Learn more
Maximize efficiency and outcomes with our project-based services, delivering specialized expertise, end-to-end biometrics, and focused solutions for unique projects, ensuring timely completion and exceptional results.
Project-Based Analytical Solutions
Cytel's software platform enables precise trial design and simulation, utilizing adaptive and Bayesian tools to optimize protocols and accelerate drug development with confidence and efficiency.
Learn more
Our unique software package streamlines trial implementation with intuitive solutions for protocol development, randomization, and patient management, optimizing operational efficiency and ensuring study success.
Learn more
Our innovative preclinical solutions empower your drug development journey with cutting-edge analytics and insights from inception to preclinical stages.
We help you navigate complex trial phases efficiently with data-driven methods & strategies tailored to Phase I-III trials for accelerated drug development.
Maximize your market potential and optimize your commercial strategies with our advanced analytical methods, data science, and tailored commercialization solutions for data-driven commercial success.
Harness the power of real-world data and real-world evidence to gather insights and shape future drug development cycles for enhanced efficacy and regulatory compliance.
Craft optimal trial designs with our advanced analytical methods to enhance efficiency and increase the probability of success throughout your drug’s lifecycle.
Empower your trial delivery by transforming trial designs into actionable strategies with our data-driven approach to ensure seamless delivery and successful outcomes.
Unlock the power of data with our methods for actionable insights to drive informed decisions and optimize clinical trial outcomes.
We offer tailored analytics solutions for your specialized or niche projects enabling you to optimize both efficiency and precision in drug development.
Enhance your clinical trial design with our strategic consulting services, featuring adaptive trial models and comprehensive regulatory guidance to ensure innovative, compliant, and successful trial outcomes.
Experience the future of flexible strategic partnerships with Analytics on Demand, providing adaptive and innovative solutions that transcend traditional models to achieve unparalleled operational excellence.
Maximize efficiency and outcomes with our project-based services, delivering specialized expertise, end-to-end biometrics, and focused solutions for unique projects, ensuring timely completion and exceptional results.
Cytel's software platform enables precise trial design and simulation, utilizing adaptive and Bayesian tools to optimize protocols and accelerate drug development with confidence and efficiency.
Our unique software package streamlines trial implementation with intuitive solutions for protocol development, randomization, and patient management, optimizing operational efficiency and ensuring study success.
By Grammati Sarri, Evie Merinopoulou, Vinusha Kalatharan, and Jason Simeone
The Canadian Agency for Drugs and Technologies in Health’s (CADTH) long-expected guidance on real-world evidence (RWE) is now in the public domain; however, it solely provides standardized (core) reporting practices for manufacturers submitting RWE studies to support their drugs applications, and important aspects of the incorporation of RWE in decision-making are missing.
Read more »
When new treatments are compared with existing therapies in clinical care, population-adjustment techniques need to ensure that the populations in the compared treatments are similar. Key to this process is the identification of effect modifiers: that is, factors, like demographic characteristics or genetics, that can alter the effect of a treatment on a clinical outcome and impact relative effects. Ensuring an unbiased selection of effect modifiers can translate to more confident downstream decision-making throughout the process of obtaining payer approval.
Real-world data has been increasingly used to answer questions related to the course, prognosis, and treatment of multiple sclerosis – yet each data source has its limitations, restricting the questions that can be addressed. Here is our solution.
Read more »
The draft Implementing Act of the EU Health Technology Assessment Regulation (HTAR) for Joint Clinical Assessments (JCA) of medicinal products — the first legal definition of the procedural and methodological details for the new EU HTAR JCA — was published by the European Commission on March 5, 2024, following some delay.1 The draft is currently open for public consultation until April 2, and feedback received will be considered before the European Commission finalizes the Implementation Act.
Here, we delve into the key elements of the Implementing Act and the implications for sponsors.
Asthma affects more than 235 million people worldwide, and due to lacking effective implementation of clinical guidelines, there continue to be high rates of uncontrolled asthma. In order to evaluate differences in healthcare resource utilization and cost among patients with controlled and uncontrolled asthma in Germany, Cytel experts applied a unique approach: a linked data study comparing insurance claims data with primary data. Let’s take a closer look: Read more »
Written by Marie Diamond and Maria Rizzo
Systematic literature reviews (SLR) are essential to informing healthcare decision-making and are pivotal for reimbursement submissions to health technology assessment (HTA) bodies. One limitation of SLRs, however, is that they quickly become outdated due to the continuous publication of new literature. The living systematic review (LSR) model can overcome this challenge by incorporating relevant new evidence as it is published. Read more »
Written by Alind Gupta, Cytel; Haridarshan Patel, Horizon Therapeutics; and Jason Simeone, Cytel
Ophthalmology is well-suited to using artificial intelligence (AI) methods because clinical decisions often rely on complex data-rich information from medical images of the eye and patient health status. AI has revolutionized image data analysis over the last decade and is promising to improve healthcare delivery and clinical decision-making while reducing healthcare costs. In fact, some AI-based diagnostic platforms for early detection of diabetic retinopathy have received FDA clearance and have been introduced in resource-constrained healthcare settings worldwide to screen for early signs of disease and to accelerate patient access to correct therapies. Read more »
Moving beyond static evidence development to ensure local market access success; responding to recent changes in governmental drug regulations and the role of automation
The worldwide drug regulation landscape is rapidly changing. The introduction of the EU Health Technology Assessment (HTA) Regulation (EU) 2021/2282 and US Inflation Reduction Act (IRA) created a need for pharmaceutical companies to develop strategies to generate data through diverse patient data sources and use complex methodologies while keeping pace with evolving evidentiary requirements for their products across healthcare decision-making bodies. Read more »
An interview with Miguel Hernán, Harvard University Kolokotrones Professor of Biostatistics and Epidemiology
On March 15, 2023, the United States Center for Medicare and Medicaid Services (CMS) issued draft guidance on the implementation of the Drug Price Negotiation Program, established under the Inflation Reduction Act (IRA) of 2022. This program includes a definition of maximum fair price, based on key elements including comparative effectiveness data and information about a drug’s impact on specific Medicare populations. To inform those topics, the CMS intends to review existing literature and real-world evidence, conduct internal analytics, and consult subject matter and clinical experts.
When submitting systematic literature reviews to a Health Technology Assessment authority, high volumes of research output have led industry bodies like PRISMA and Cochrane to call for a paradigm shift towards “Living HTA” models that organize and update evidence in a more continuous manner. In the past decade such concepts have been introduced for both SLRs and network meta-analyses, but the industry has been hesitant to take up this approach in practice. A new Cytel whitepaper aims to provide a blueprint for those seeking to access evidence quickly, and integrate the most up-to-date science into research, such as SLRs.
