Confidence intervals are an important component of clinical trial reporting, supporting the accurate and reliable interpretation of study results.  When analyzing percentages in multicenter trials, key considerations include which confidence interval method to use and whether, and how, to account for differences between centers. For a 95% confidence interval, coverage should be approximately 95%, while […]

Bayesian methods are increasingly being considered to support dose optimization, extrapolation, and adaptive designs in clinical development. However, regulatory expectations vary across regions and continue to evolve.  This webinar brings together three regional perspectives on the current regulatory landscape: the FDA’s draft guidance on Bayesian statistics, China’s CDE guidance on Bayesian approaches, and Bayesian-relevant expectations […]

As the functional service provider biometrics model evolves, so too must the way sponsors measure its success. Traditional metrics such as headcount, onboarding speed, and blended rates no longer reflect the realities of today’s clinical environment. To unlock the full value of flexible biometrics FSP solutions, organizations must focus on what truly drives outcomes. This blog explains […]

Augmenting Clinical Trials with Synthetic or Simulated Patients, Projecting Long-Term Benefit-Risk, and Developing Regulatory-Grade External Controls In our final session, we’ll explore how AI is revolutionizing clinical trials through predictive modeling and the use of synthetic and simulated patients. We’ll discuss digital twins, virtual cohort simulations, and how to integrate real-world evidence (RWE) into trial […]

Bayesian methods continue to gain momentum as an alternative approach to traditional clinical trial design, yet many organizations still have limited experience applying them, particularly when engaging with regulators. With multiple global agencies releasing further guidance in this area, it is useful to understand the current landscape of this trial area. In this webinar, we […]

Automate Programming and QC Processes, Accelerating Operations and Evidence Generation This session will explore AI’s role in automating critical tasks in drug development. We will showcase how AI-powered technologies have been used to automate programming QC, systematic literature reviews, and streamline the identification of trial centers and KOLs, while highlighting AI’s role across clinical workflows […]

Drug development in rare diseases requires the most efficient use of limited data, across both clinical trials and real-world settings. In this webinar, we will explore how combining predictive disease and care modeling with real-world data (RWD) can help translate efficacy observed in clinical trials into real-world effectiveness.  Using practical examples from rare disease settings, […]

About This Webinar In this session, we explore real-world use cases where AI and LLMs (Large Language Models) have been applied to explore large data sources such as omics, literature, and real-world data (RWD). We explore how AI can help identify optimal target populations, endpoints, and even support drug repurposing. Speaker: Billy Amzal, Ph.D.Head of […]

About This Webinar As expectations for robust, real-world evidence continue to grow, understanding how regulators evaluate causal analyses is becoming increasingly important. In this session, we will explore why causality matters, how agencies such as the FDA, EMA, and NICE are viewing causal inference, and what this means for study design and regulatory submissions. Speakers […]

Stephen Corson, Director of Operational Solutions at Phastar, explores the evolving role of contract research organizations (CROs) in a new article on clinical trial transformation for Contract Pharma. The piece examines how CROs are shifting from execution partners to strategic collaborators, and how functional service provider (FSP) models are reshaping outsourcing approaches. He highlights the […]

This webinar will cover methods that are crucial to making informed decisions. Specifically, personalized care through causal and federated learning, targeted maximum likelihood estimation (TMLE) and doubly robust methods.   Speakers: Ryan Batten, Senior Statistician, Phastar Julie Joss, Senior Researcher, Inria Josh Enxing, Senior Programmer, Phastar- Moderator Learning Points: Distinguishing correlation from causation in the […]

You were among the first to submit and defend a Bayesian trial design to the FDA around 20 years ago. How were Bayesian methods viewed by regulators at that time?     At that time, the statistical community was still quite split between frequentists and Bayesians, so it seemed additional educational work was required. In the early 2000’s, Bayesian approaches were viewed mostly as exploratory tools, essentially for early phases, in indications […]

Phastar is sponsoring BBSW 2026, 5-6 November in Foster City, CA. Connect below to set-up a meeting or stop by Booth #2 to engage with our team. Schedule a meeting with us below:

Phastar is excited to be attending European Statistical Forum, 12 – 13 November in NH Budapest City, Budapest. Connect with us at our presentation or request a meeting below: Experiences of Utilizing the BOIN12 Method for Designing Rare/Small Population Oncology TrialsGiles Partington, Consultant Statistician13 November 2026 Schedule a time to meet below:

Phastar is excited to be attending PHUSE EU Connect, 15 – 18 November in Glasgow, Scotland Connect with us below or visit us at booth #31, our poster or one of our presentations to learn more about our solutions. Poster: The Mouse Behind the KeyboardChoe Floodgate, Senior Programmer I17 November, 17:30 GMT, Hall 2 | […]

Phastar is exhibiting at the PSI Medical Statistics Careers Event at, 18 November Cutler’s Hall in Sheffield. Connect below to set-up a meeting or stop by our table to connect with our team. Schedule a meeting with us below:

Phastar is sponsoring SCOPE Summit 2027, 1-4 March in Orlando, FL Connect below to set-up a meeting or stop by Booth #427 to engage with our team. Schedule a meeting with us below:

Causal inference is increasingly used to generate real-world evidence (RWE), by regulatory bodies and health technology assessment. This webinar introduces what is required to support causal claims, how causality can be evaluated across different study designs, and why this shift is particularly relevant for RWE today.   Speakers: Ryan Batten, Senior Statistician Josh Enxing, Senior Programmer- Moderator Learning Points: Distinguishing correlation from causation in the context of clinical and […]

The early stages of clinical development are critical, and the decisions made here determine not only the efficiency and cost of a program but ultimately whether a promising compound reaches patients at all. As the therapeutic landscape evolves and the demand for innovative trial designs grows, early-phase studies have become an ever-changing and rapidly advancing […]

Use of external data to augment clinical trials has been increasingly evaluated and is transforming drug development paradigms.   Numerous innovative methods including hybrid designs, Bayesian borrowing and disease modeling have been developed, raising the new regulatory question: “Is the data we observe similar to the data we predicted or intended to include?”    The […]

The demand for rapid, cost-effective, and standards-compliant SDTM delivery continues to increase across the biotech and pharmaceutical industry. While company level SDTM standards and SAS macro-based solutions have fulfilled the needs for many years, they can still be restrictive and less adaptable in today’s evolving trial landscape and performance requirements.  This webinar series will discuss the practical […]

The adoption of advanced technological tools in clinical trials is accelerating as sponsors seek faster insights, stronger compliance, and improved decision-making. In an article for Applied Clinical Trials, Christian Schmidt, Associate Director at Phastar, explains how combining tech innovation with deep therapeutic expertise can transform complex trial data into clear, actionable intelligence. ”Customizable tools can […]

The early stages of clinical development are critical, decisions made here can determine the efficiency, cost, and ultimate success of an entire program. With the evolving landscape of early phase drug development, sponsors need flexible yet robust statistical approaches to ensure that promising compounds are evaluated effectively and efficiently. Getting this stage right not only […]

Real-world data (RWD) are transforming clinical research. By supplementing randomized controlled trials (RCTs), RWD can de-risk studies and improve generalizability. Innovative designs, from hybrid RCTs to registry-based trials, are gaining traction, with regulators setting clear standards for their use. This webinar shares case studies, practical methodologies, and key considerations to help you apply RWD effectively […]

Data Monitoring Committees (DMC) are a critical part of the clinical trial process, independently assessing the safety of an investigational product and at times the futility/efficacy. Successfully navigating DMC set-up, logistics, and independent data review can be complex, especially for biotech and smaller sponsors without in-house expertise.  Speakers: Lucy Clark, Statistics Manager Lisa Gibbons, Senior […]

Phastar recently welcomed Billy Amzal as Head of Strategic Consulting. A statistician, public health scientist, and entrepreneur, Billy brings more than 25 years of experience across the biotech and pharmaceutical industries, health agencies, and consulting.  His expertise lies in innovative, regulatory-grade statistical methodologies including adaptive trial designs, model-based meta-analysis, Bayesian approaches, and predictive modeling using […]

As a follow-up to Clinical Trials Day 2025, with the theme of being “Powered By Purpose,” industry thought leaders shared their perspectives with ACRP on their clinical research powers, and on what they see as being the greatest current challenges and opportunities facing the field today. In June’s issue ACRP Clinical Researcher, Phastar’s Chief Operating […]

In a recent Q&A with European Biopharmaceutical Review, Stephen Corson—Associate Director of Statistics and Technical Solutions and Head of Statistical Consultancy at Phastar—shared expert insights on the strategic decisions that biotechs must make to ensure successful drug development. A key focus of the discussion was the importance of selecting the right biotech solutions provider and […]

Sponsors working in rare diseases/running small population studies often have difficulties in demonstrating efficacy due to the small number of patients available for analyses. Bayesian methods offer promising solutions for small population and rare disease trials where leveraging available data can provide important insights and evidence. Discover the importance of Bayesian trial designs and the […]

Real World Evidence (RWE) plays a critical role across multiple pharma processes, including drug development, regulatory decision-making, precision medicine and health economics, providing valuable insights from actual clinical practice. In order to leverage these data effectively and make informed decisions, sponsors need to be aware of the types of data that are available and the […]

With biotechs increasingly driving innovation in research and development, it is important for organizations to choose the right outsourcing partner to overcome challenges around data, infrastructure and expertise. But how can biotechs do this best? Stephen Corson’s, Associate Director of Statistics and Technical Solutions and Head of Statistical Consultancy at Phastar, article with Journal for […]

Introduction  For biotechs looking to advance clinical development, selecting the right CRO partner can be a defining decision. This choice directly influences the success of clinical trials, overall project timelines, and long-term outcomes. This blog explores what biotech solutions should be considered to ensure a productive and successful CRO partnership. Therapeutic Expertise and Specialized Knowledge: […]

Introduction  In today’s fast-evolving environment, biotechs need to form strategic partnerships to address resource and expertise gaps, ensuring they stay competitive and navigate the complexities of the industry effectively.  Partnering with a CRO can empower biotechs to thrive by providing access to essential resources, expertise, and scalability that might otherwise be out of reach. CROs […]

Introduction  The biotech industry has become a driving force in clinical research, accelerating advances in areas such as precision medicine, oncology, and rare disease therapies. However, unlike larger pharmaceutical companies, many biotechs are challenged by limited resources and capabilities to manage complex trials, leading to a growing reliance on Clinical Research Organizations (CROs) for expertise, […]