Lewis Moores

The biotech industry is evolving rapidly, with emerging companies leading the charge in clinical development. As outsourcing to CROs (Contract Research Organizations) grows, choosing the right partner is more critical than ever. This comprehensive white paper provides actionable insights and top tips for biotech companies navigating the vendor selection process.  What you’ll learn: The key […]

In our “Meet the Team” series, we highlight the talented individuals who drive Phastar’s success. Each team member brings unique skills, experience, and passion to their role, working together to deliver high-quality biometrics and data science solutions in clinical research. Below, we share their career journey, insights, and the impact they make every day. Can […]

In the evolving landscape of clinical trials, data monitoring has traditionally been a one-way street, data flows from electronic data capture (EDC) or other source data systems into dashboards for review, but user inputs into the data systems often require cumbersome manual processes. At Phastar, we’re building a future where clinical trial data portals function […]

Discover how Bayesian statistics can enhance clinical trial efficiency and improve decision-making. Our latest white paper, authored by Giles Partington, Consultant Statistician at Phastar, explores how Bayesian methods address key challenges in clinical research.  Key insights include: How Bayesian frameworks differ from traditional frequentist approaches The role of prior elicitation in enhancing trial design Practical […]

Introduction   Our webinar explored the use of expert prior elicitation techniques in clinical research, particularly in the context of Bayesian statistics. The event featured presentations from experts in the field, including Professor Thomas Jaki from the University of Regensburg and the University of Cambridge, Nigel Dallow from GSK, and statisticians from Phastar. Introduction to Prior […]

Early phase trials play a crucial role in drug development, determining the dose to test in later phases. With the rise of combination treatments, there is a growing need for innovative and efficient trial designs to navigate this complex landscape. Discover how new research is paving the way for more efficient and flexible strategies in […]

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: […]

Discover how Real-World Evidence (RWE) is revolutionizing drug development and clinical decision-making in our latest whitepaper.  What You’ll Learn:  Featuring a Real-World Case Study with AstraZeneca:  Explore how our partnership with AstraZeneca harnessed machine learning and RWE to transform treatment decision-making for non-small cell lung cancer (NSCLC).  This whitepaper is essential for clinical researchers, pharmaceutical […]

Understanding causal relationships in real-world data is challenging, particularly in observational studies, where confounding can introduce bias. If confounding is not properly accounted for, treatment effect estimates may be misleading, impacting decision-making. Therefore, correctly modelling confounding is essential for valid causal inferences. Two popular approaches to achieve this are inverse probability of treatment weighting (IPTW) […]

During our recent webinar, we brought together key industry leaders to discuss the evolution and strategic value of Functional Service Provider (FSP) models in clinical trials. The panel included Natalie Fforde, Senior Vice President of Global Strategic Partnerships at Phastar; Francis Kendall, Head of Statistical Programming, Digital and Data Sciences at Biogen; Elisa Mansfield, Vice […]

Introduction Integrating Real-World Data (RWD) and Real-World Evidence (RWE) into clinical research is gaining significant traction, due to the wide range of benefits it brings. However, integration of RWE into clinical research and trials can come with specific technical challenges such as handling unstructured data, standardizing data across multiple sources, and navigating regulatory and ethical […]

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 […]

Real-World Evidence (RWE) is redefining how healthcare and drug development insights are generated. This blog explores the advantages utilizing RWE can offer, the factors driving its growing significance, and the benefits that utilizing it brings to regulators, patients, and pharma companies.  What Is RWE?  RWE is derived from analyzing Real-World Data (RWD)—information gathered from sources […]

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, […]

The implementation of the New Health Technology Assessment (HTA) framework in Europe is a pivotal moment for the region’s healthcare landscape. While this initiative promises to streamline and harmonize the evaluation of health technologies across the European Union (EU), it also presents several significant challenges that stakeholders must address.  This blog explores the challenges and […]

Real-world data (RWD) and real-world evidence (RWE) are transforming the clinical research landscape. During our recent webinar, Phastar’s experts explored the growing impact of RWD and RWE, highlighting their use in clinical trials, regulatory decision-making, and real-world applications. The session included presentations from Phastar’s expert statisticians and data scientists, offering practical insights into how these […]

London, UK, and Durham (NC), US – December 9th, 2024: Phastar, a global specialist biometrics contract research organization (CRO), has won the Best CRO – Specialist Providers category at the 2024 Scrip Awards. Presented at Raffles London at the OWO on Wednesday, December 4th, Phastar was recognized for its high-quality, specialized biometrics solutions, advanced clinical […]

Introduction  Phastar’s recent webinar, “Implementing a Gold Standard FSP Strategic Partnership to Fuel Efficient Drug Development,” provided valuable insights on key aspects of functional service provider (FSP) collaborations and their impact on drug development, particularly in oncology.   Our panel of experts discussed strategies for maximizing FSP solutions. They highlighted how to achieve excellence in quality, […]

Introduction  The EU Health Technology Assessment (HTA) is set to undergo significant transformation at the beginning of next year, with the upcoming joint clinical assessments (JCAs) aiming to streamline processes across member states. The new framework marks a substantial departure from the previous decentralized model of HTA in Europe.   This shift presents both opportunities and […]

In Partnership With PCMG Phastar and PCMG partnered to start 2025 with an insightful fireside chat, sharing their industry-leading expertise on optimizing clinical trial outsourcing. The Pharmaceutical Contract Management Group (PCMG) is a membership association that unites and connects professionals working in clinical development outsourcing, procurement, and contract management. In today’s dynamic pharmaceutical and biotech landscape the […]

Introduction Health Technology Assessments (HTA) are a vital process within healthcare systems, evaluating the value of medical interventions, such as drugs and medical devices, based on their clinical, economic, and ethical impacts. Traditionally, HTAs have been conducted on a national level across Europe, leading to significant variations in how health technologies are assessed and adopted […]

Real World Evidence (RWE) is playing an important role in the drug development process by providing valuable insights from real world 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 challenges associated with using them, as […]

Introduction  Risk-Based Quality Management (RBQM) has emerged as a powerful tool for optimizing clinical trial operations. While its benefits—such as near real-time data access, improved resource allocation, and enhanced patient safety—are well-known, its adoption across the industry has been slower than anticipated. Data from the Association of Clinical Research Organizations (ACRO) highlights that the implementation […]

Our recent webinar explored the complexities of Health Technology Assessments (HTA), their current role in evaluating healthcare technologies, and the upcoming changes to HTA regulations in Europe.   The upcoming regulatory shift will require developers to generate a substantial body of evidence within much shorter timelines than current guidelines require. To help you prepare for this […]

Introduction  Risk-Based Quality Management (RBQM) is revolutionizing the way clinical trials are managed, offering a modernized, efficient, and data-driven approach to oversight. Traditional methods that rely heavily on frequent on-site visits and 100% source data verification (SDV) are resource-intensive, costly, and often inefficient. RBQM applications streamline these processes, helping clinical operations teams focus on high-risk […]

As oncology drug development continues to evolve, the FDA’s Project Optimus is reshaping how clinical trials approach dosing—moving away from the traditional maximum tolerated dose (MTD) model towards a focus on dose optimization. This initiative aims to enhance the safety and efficacy of cancer treatments, ensuring patients receive the best possible therapeutic outcomes with minimal […]

In the dynamic world of clinical research, selecting the right Contract Research Organization (CRO) partner is more important than ever. As clinical trials grow increasingly complex, the demand for specialized expertise and strategic partnerships is reshaping how sponsors choose their CROs. To understand what matters most in this decision-making process, we recently conducted a poll […]

In the rapidly advancing world of clinical trials, data visualization plays a transformative role by enhancing efficiency, improving participant safety, and enabling data-driven decisions. By converting complex data into clear, actionable visuals, researchers can quickly identify patterns and insights that drive better outcomes and streamline trial processes.  This blog explores the significance of data visualization […]

Since the introduction of Project Optimus by the FDA in 2020 [1], it has become more important than ever to ensure that oncology trials consider both efficacy and toxicity from the earliest phase. Similarly, it is key to consider ranges of doses that can be investigated at later stages. This means that rather than looking […]

Psoriasis is an inflammatory disease characterised by lesions on the skin and has a prevalence of around 2% in the global population. To date, a Phastar client has conducted three randomized placebo-controlled trials with their study drug, all achieving a p-value <0.001 demonstrating efficacy. There are a variety of methods to treat skin conditions that […]

Phastar’s Data Analytics and Visualization Portal and commitment to high ESG standards secures shortlist spot at the 20th Anniversary Scrip Awards London, UK, and Durham (NC), US – 24th September 2024: Phastar, global specialist biometrics contract research organization (CRO), has been named as a finalist for the Best Contract Research Organization – Specialist Providers category […]

The landscape of clinical trials is undergoing a significant transformation, driven by rapid advancements in technology and data science. To gauge the industry’s perspective on which innovations will most impact clinical trials in the coming years, we conducted a poll asking professionals to share their views. Here’s a summary of what we found and how […]

With the upcoming introduction of the new EU HTA guidance in January 2025, sponsors in the pharmaceutical, Biotech and medical device sectors will face a significant regulatory shift. This change will demand the generation of a substantial body of evidence within stringent timelines. To help you prepare for this transition, we are hosting an informative […]

Managing clinical trials is no easy task, with a range of challenges that can impact the success of a study. To gain deeper insights into these hurdles, we recently asked industry professionals to identify their biggest challenge in clinical trial management. Poll Overview: What Are the Biggest Challenges? We asked industry professionals: What’s the most […]

Introduction Project Optimus marks a major advancement in optimizing patient outcomes in oncology. By prioritizing dose optimization, this groundbreaking initiative aims to enhance the efficacy and safety of cancer treatments and improve drug development processes. However, implementing Project Optimus comes with its own set of challenges. This blog discusses the complexities of aligning clinical trial […]

Introduction With the launch of Project Optimus, the FDA is overhauling the paradigm of dose optimization and selection in oncology drug development. This initiative tackles the problem of poorly characterized doses and schedules, which can result in increased toxicity without enhancing efficacy.   This transformation will require substantial changes in the design and execution of early […]

Phastar continues to lead the CRO industry in corporate responsibility as CEO Graham Clark is named in list of trailblazers, innovators and visionaries. London, UK, and Durham (NC), US – 15th August 2024: Phastar, global specialist biometrics contract research organization (CRO), has been recognized in the 2024 Environment 100 List, led by Graham Clark. The award […]

Introduction The Project Optimus initiative is a key part of the U.S. Food and Drug Administration (FDA’s) Oncology Center of Excellence (OCE) and represents a shift in the agency’s approach to cancer treatment dosing. [1] The three main goals of Project Optimus are:  These goals are to ensure that more patients receive the appropriate dose […]

By Michael Willis, MSc, Senior Statistician, and Lisa Gibbons, MSc, Senior Statistician Introduction The landscape of clinical trials is changing, with sponsors looking for more ways to make trials quicker and more efficient, thus shortening drug development timelines and bringing important new treatments to patients faster. Innovations exist in the study set-up, recruitment, delivery, and […]

Introduction With the launch of Project Optimus, the FDA aims to reform the dose optimization and dose selection paradigm in oncology drug development. The initiative addresses the issue of poorly characterized doses and schedules, which can lead to increased toxicity without additional efficacy.   This transformation necessitates significant changes in how early phase trials are designed […]

By Wei Liu, PhD, Associate Director, Biostatistics, and Gillian Armstrong, MSc, Consultant Statistician The FDA recently published a draft guidance on the Use of Data Monitoring Committees (DMCs) in Clinical Trials for consultation. Leveraging our substantial expertise in DMCs, a select group of Phastar statisticians thoroughly reviewed and provided insightful comments on the guidance. By […]

“In data management, we are already seeing how AI can be used to power data review, risk management, and enable automatic coding through interactive data monitoring platforms.” Phastar CEO, Graham Clark, contributed to the latest Vox Pop Pharma feature for Outsourcing Pharma. Alongside other industry thought leaders, Graham gave his views on where AI will take […]

‘Statistics and the interpretation of statistical results are an important part of what researchers do and how healthcare teams make decisions on how best to help their patients. To do so effectively, it is imperative that we ensure we all have clear lines of communication and effective collaboration.’ Stephen Corson, Associate Director, Statistics and Technical […]

Wei Liu, Associate Director of Statistics at Phastar, recently co-authored a manuscript published in the Journal of the National Cancer Institute. The study focuses on neurocognitive impairments in adult survivors of childhood cancer, aiming to identify common phenotypes and modifiable risk factors for personalized interventions. To read the full paper visit the Journal of the […]

With the launch of Project Optimus, the FDA is reforming the dose optimization and dose selection paradigm in oncology drug development. The initiative addresses the issue of poorly characterized doses and schedules, which can lead to increased toxicity without additional efficacy. This transformation necessitates significant changes in how early phase trials are designed and conducted. […]

By Tina Hovey, Principal Statistician, and Gillian Armstrong, Consultant Statistician, Phastar The FDA recently published a draft guidance on Master Protocols for Drug and Biological Product Development (fda.gov) for public consultation and feedback from interested parties (such as the PSI Regulatory Special Interest Group). At Phastar, we have substantial expertise in Master Protocols therefore, our […]

Medical monitoring is one of the most important aspects of any clinical trial, but traditional approaches are time-consuming, leave room for error, and provide only a limited view of the data. Guided analytics consolidates near real-time data from multiple sources into a single, filterable dashboard, providing users with step-by-step assistance in exploring, analyzing, and interpreting […]

Phastar CEO, Graham Clark, recently spoke with Contract Pharma regarding the current trends, challenges, and growth drivers in the CRO industry. In this wide-ranging discussion, Graham emphasised the need for CROs to be adaptable, innovative, and proactive to meet the evolving needs of the pharmaceutical and biotech industries while navigating complex regulatory environments and technological […]

Introduction An abundant problem in clinical trials is the absence of data due to patients prematurely withdrawing from trial participation. Censoring is a common characteristic in longitudinal trials that collect time to event data. Usual methods of analysis can be implemented if the data is assumed to be censored at random (CAR). However, if this […]

Ahead of DIA 2024, Phastar CEO Graham Clark spoke with Outsourcing Pharma about the major trends and challenges in the pharmaceutical industry, highlighting the transformative role of AI in data analysis and the need for collaborations to harness AI effectively. Graham also reiterated Phastar’s commitment to corporate responsibility and sustainability, with the company aiming to […]

The way health technology assessments (HTAs) are conducted in Europe is undergoing a significanttransformation. Starting next year, all new advanced therapeutic products and oncology drugs will be subject to a mandatory, EU-wide joint clinical assessment (JCA). By 2030, this will extend to orphan drugs, class IIb or III medical devices, and class D in vitro […]

Originally published in Business Wire. Boston, MA US – 20th May 2024: Beaconcure Inc., a leader in AI-enabled clinical data validation and automation, announces a strategic partnership with Phastar Inc., a global specialist biometrics contract research organization (CRO), to enhance clinical review processes in clinical trials. This partnership combines Beaconcure’s advanced technology with Phastar’s extensive experience and vision […]

Ahead of the UK’s Mental Health Awareness Week, Peter Taylor, Phastar’s Senior Director and Global head of Human Resources, recently spoke with Outsourcing Pharma about the importance of employers utilizing data-driven approaches to improve staff mental health. Remarking on statistics showing a decline in mental health since 2020, Peter suggests implementing strategies like employer-sponsored digital […]

Giles Partington, Principal Statistician at Phastar, recently provided an article for Clinical Research News explaining the basis of Bayesian statistics and discussing the application of this approach, particularly within rare disease trials, along with the opportunities and challenges. Read the full article here: https://www.clinicalresearchnewsonline.com/news/2024/04/26/bayesian-statistics-an-important-yet-underutilized-paradigm-in-rare-disease-and-small-population-drug-development

Professor Jennifer Visser-Rogers recently spoke with Outsourcing Pharma about her experience as a woman in science. As an honoree of Women in Data® Twenty in Data & Technology, she discusses the challenges she has faced, a mathematical passion that fueled her future in life science, and her advice for others wanting to follow the same […]