Clinical development teams are often familiar with outsourcing activities such as monitoring, project management, and regulatory affairs. Biometrics, however, can be less visible to sponsors who are new to outsourcing and may not fully understand the functions that sit beneath the term. Yet biometrics plays a central role in determining whether study data can withstand […]

In a new article for PharmaTimes, Sarah Tucker, Chief Operating Officer at Phastar, explores how Functional Service Provider (FSP) models are evolving to meet the demands of increasingly complex clinical development programs. Sarah examines the trends reshaping clinical trial outsourcing, including the growing need for specialist expertise, greater operational flexibility, and stronger sponsor oversight. She […]

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 […]

Choosing a clinical data management CRO can feel challenging when many providers make similar claims about quality, compliance, and experience. However, the true differences between providers often only become apparent later in a study, when database lock deadlines are approaching, third-party data needs reconciling, or regulators are scrutinizing data quality and traceability. This blog explores […]

Progression-free survival (PFS) offers sponsors the opportunity to assess treatment benefit earlier than overall survival (OS), potentially accelerating development timelines and bringing promising therapies to patients sooner. However, while PFS is frequently used as a primary endpoint in oncology studies, its interpretation is often more complex than many stakeholders realize. This blog explores the opportunities […]

Strong partnerships and specialist expertise are key to the success of any Functional Service Provider (FSP) model. Through her role supporting Takeda, Beth McDougall works as an embedded statistical partner, providing expert oncology-focused support while collaborating closely with teams to deliver high-quality analyses and contribute to research that advances understanding across the oncology clinical trial […]

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 […]

Artificial intelligence is transforming how life sciences organizations generate evidence, design clinical trials, and make critical development decisions. But beyond the hype, where is AI delivering real value today? In this whitepaper, Billy Amzal, PhD explores how AI is being applied across three critical domains: Exploration, Automation, and Prediction to help organizations uncover new insights, […]

Oncology is a rapidly developing and expanding area of therapeutic development with more new drugs and supplemental indications obtaining FDA approval in the past five years compared to all previous years combined.[1] Amid this surge of new treatment options, sponsors and their partners must navigate several persistent challenges. This blog explores the key challenges facing […]

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 […]

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, […]

To mark Clinical Trials Day 2026, Matt George, Senior Statistician, and Sam Hinsley, Statistics Manager at Phastar, highlight how statistical innovation is reshaping early-phase clinical trials in a comment for ACRP Clinical Researcher. They discuss the growing complexity introduced by early-phase combination trials, where traditional approaches can lead to overly conservative or unsafe dose recommendations. […]

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 […]

To mark Clinical trials day 2026, in a video interview for Applied Clinical Trials, Sam Hinsley, statistics manager at Phastar, highlights the vital role statisticians play in improving clinical trial success. She reflects on how personal experience and professional responsibility intersect, emphasizing that statisticians are stewards of patient data and must balance innovation with rigor. […]

Sarah Tucker, Chief Operational Officer at Phastar, explores the evolution of Functional Service Provider (FSP) models in modern drug development, highlighting the shift from headcount-driven outsourcing to performance-led delivery. In this latest article for the Journal of Clinical Studies, she outlines how sponsors are redefining success through measurable outcomes such as cycle time, right-first-time quality, […]

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 […]

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 […]

Early-phase oncology combination trials often assume the optimal dose is already included in the dosing grid. When it isn’t, sponsors may face subtherapeutic or overly toxic recommendations, protocol amendments, and delays.  This white paper explores a contour-based method for inserting new dose combinations mid-trial, helping improve dose selection while maintaining safety and regulatory transparency.  What You’ll Learn  About the Author  Matt George, Senior Statistician, Phastar Specialist […]

Sam Hinsley, Statistics Manager at Phastar, shares practical insights into early phase clinical trial design in a new article for Biopharm International. The piece explores the evolving statistical approaches shaping modern drug development. She examines how Phase I trials are moving beyond the traditional focus on maximum tolerated dose (MTD) toward identifying optimal biological dose […]

Real-world evidence (RWE) is no longer peripheral to drug development. Across regulatory, HTA and payer environments, expectations have been shifting rapidly, driven by policy evolution, data availability, and the growing influence of AI-enabled analytics. For sponsors, the question is no longer whether to integrate RWE across drug development stages, but how early, how credibly, and how strategically.  This perspective, authored by Billy […]

To mark International Women’s Day 2026, a new article in Applied Clinical Trials authored by Vicky Marriott, Head of Statistics at Phastar, explores why advancing gender equality in statistics and data science is essential for innovation, collaboration, and long-term industry growth. The article examines the barriers women continue to face across education and career progression […]

To mark International Women’s Day 2026, a new article in PharmaLive, authored by Sarah Tucker, Chief Operating Officer at Phastar, explores how visible, inclusive leadership and strong female representation across technical and executive teams are driving operational excellence, stronger decision-making, and improved outcomes in clinical research, while reinforcing the business case for diversity in a […]

Billy Amzal, Head of Strategic Consulting at Phastar, and a Bayesian design expert and pioneer, explores the techniques used in Bayesian trial designs, examines regulatory updates, and shares real-world examples of the impact of these innovative methods in a new article for Applied Clinical Trials. “With rare disease a growing area of clinical research and […]

To mark Rare Disease Day 2026, a new article authored by Billy Amzal, Head of Strategic Consulting at Phastar, explores how external control arms, Bayesian borrowing, and AI-enabled digital twins can strengthen evidence generation and accelerate rare disease drug development, while meeting evolving expectations from regulators such as the FDA and MHRA. ”Innovative trial designs […]

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 […]

As innovative clinical trial designs gain traction, sponsors are looking more closely at how real-world data can be used to strengthen evidence generation without compromising rigor. Clearer regulatory guidance, improved data access, and advances in analytics are opening the door to more sophisticated approaches, but only when RWD is applied with intent and discipline. In […]

As innovation reshapes drug development, industry leaders are looking ahead to how both preclinical discovery and clinical trials will evolve in 2026, and the role regulators will play in shaping that future. Advances in structural biology, hybrid study designs, and the expanding use of real-world evidence are expected to influence decision-making earlier and more meaningfully […]

Phastar is delighted to be exhibiting at PHUSE APAC Connect 2027, 28-30 January in Bengaluru, India. Visit the Phastar team at our exhibit or visit our posters and presentations to find out more about our solutions. Schedule a time to meet below:

On the 12th January  2026 the FDA brought out recommended guidance on the use of Bayesian methods, this marks the first time that the FDA has brought out draft guidance on Bayesian methods outside of brief mentions within other guidelines (such as the rare disease, adaptive designs and medical devices) where it is often regulated to a short paragraph or section. They are applicable to […]

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 […]

As artificial intelligence reshapes clinical development, sponsors are rethinking what they need from their CRO partners. Cost pressures, increasingly complex therapeutics, and the growing role of specialist biopharma are accelerating the shift away from scale-driven models toward agility, specialism, and smarter use of technology. In a new Clinical Research News trendspotting article, Graham Clark, CEO […]

As pharma looks ahead to 2026, greater regulatory and geopolitical clarity is expected to unlock delayed investment decisions, but this is not without new pressures. In a new article for PharmaVoice, Graham Clark, CEO of Phastar, shares his perspectives on how stabilizing policy and trade conditions may re-energize R&D, while also reshaping the industry’s economic […]

As patient-centerd research continues to shape clinical trial design, electronic patient-reported outcomes (ePROs) are increasingly being considered for use as primary endpoints. In a new article for the Journal of Clinical Studies, Barbara Arch, Principal Statistician at Phastar, examines the opportunities and challenges of using ePRO data in this way, drawing on learnings from three […]

Decentralized clinical trials (DCTs) continue to gain momentum as sponsors look to reduce participant burden, improve diversity, and expand access to research. But with the benefits of remote participation come new statistical and operational challenges that must be addressed early in trial planning. A new article published in Clinical Research News explores key considerations for […]

As APAC continues to embrace digital innovation, hybrid decentralized clinical trials (DCTs) are emerging as a practical and scalable model for broadening patient access. In a new article for BioSpectrum Asia, Ping-Chung Chang, Head of Business Transformation and China General Manager at Phastar, explores how AI-enabled data processes, real-world data growth, and improved digital infrastructures […]

As the pharmaceutical landscape evolves, traditional clinical trial designs are increasingly complemented by innovative, data-driven approaches. Real-world data (RWD) offers the potential to augment trials, simulate patient populations, and generate synthetic control arms. In-silico trials, powered by RWD and advanced analytics, help provide a path to faster, more efficient, and highly informative drug development. This […]

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 […]

As clinical trials grow increasingly complex, sponsors are turning to specialist CROs with the expertise to transform data into regulatory-grade evidence. In this article for The Medicine Maker, Stephen Corson, Associate Director of Statistics & Technical Solutions at Phastar, discusses how the CRO model is evolving, from transactional service delivery to strategic partnership, helping sponsors […]

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 […]

By Billy Amzal, Head of Strategic Consulting, Phastar  Introduction  Rare disease research demands tailored development and access strategies supported by innovative trial designs and dedicated analytics. From Bayesian designs to data augmentation approaches that strengthen probability of success, specialist CROs and experienced consultants are helping deliver smarter, faster, and more efficient drug development, ultimately bringing […]

Phastar supported a sponsor in preparing an Integrated Summary of Safety (ISS) for an investigational drug in sickle cell disease, pooling data from three studies: two Phase 3 randomized trials (single- and multiple-dose) and one open-label extension.  Key Challenges:  Our Approach: 

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 […]

Introduction   When preparing a regulatory submission, one of the most critical components is the Integrated Safety Summary (ISS). Far from being a simple aggregation of safety data, the ISS is a detailed and carefully constructed analysis that provides regulators with a complete picture of a product’s safety profile across clinical trials. This blog explores […]

Outsourcing clinical trial activities to specialist data-focused CROs is growing rapidly, driven by the need for expert data management, biostatistics, and faster time to market. These partnerships deliver cleaner, more reliable data, streamlined operations, and faster regulatory acceptance. In an article for International Clinical Trials, Stephen Corson, Associate Director, Statistics & Technical Solutions at Phastar […]

In this exclusive interview for World Pharma Today, Phastar’s Head of Strategic Consulting, Billy Amzal, shares his career insights, regulatory perspectives, and how data-driven strategies are accelerating smarter, safer, and more impactful healthcare decisions. ”We are increasingly seeing regulatory agencies specify the context of use for novel approach methodologies such as Bayesian statistics. I believe […]

In ACRP Clinical Researcher, Katie Dixon, Senior Statistician at Phastar, reflects on the transition from graduate to manager and the support required for new leaders to thrive. “As outlined in my own experience, shadow-lead roles are one way organizations can support staff as they prepare to transition into management roles. Another effective intervention is the […]

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 […]

In an exclusive interview with the European Medical Journal, Graham Clark, CEO of Phastar, discusses the current state of clinical research, the future role of AI in the industry, and how to build a values-driven company. ” The biggest challenge we face is balancing the need for speed and innovation with the imperative for quality, […]

As clinical trials become more complex and data-driven, pharmaceutical and biotech companies are increasingly seeking strategic support from specialist CROs. These data-focused partners bring deep biometrics expertise, consistent delivery, and faster access to high-quality, submission-ready data.  The global pharmaceutical CRO market was valued at over $41 billion in 2024 and is expected to grow at […]

London, UK, and Durham (NC), US – June 24th, 2025: Phastar, a global specialist biometrics & data science Contract Research Organization (CRO), today announced the appointment of Billy Amzal as Head of Strategic Consulting. Amzal is a statistician, public health scientist, and entrepreneur with more than 25 years of experience across biotech and pharmaceutical industries, […]

Introduction  Randomized Controlled Trials (RCTs) remain the cornerstone of evidence generation in clinical research, providing rigorous and unbiased assessments of treatment efficacy and safety. The frequentist framework, which underpins most traditional trial designs, relies on predefined sample sizes and statistical significance thresholds. While effective for common conditions with large patient populations, these methods often face […]

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 […]

If your clinical data review process feels slow, fragmented, or error-prone, this case study shows how Phastar and Beaconcure cut review cycle times by over 35%. Learn how a centralized platform can: Whether you’re a sponsor, CRO, or data manager, this is essential reading to modernize your review workflows and accelerate trial timelines. Complete the […]

In Giles Partington’s recent article for Pharmaceutical Outsourcing, the Phastar Principal Statistician explores how expert prior elicitation can enhance clinical research—particularly in areas with limited data, such as rare diseases and early-phase development. He outlines how this structured approach enables teams to formally incorporate expert opinion into Bayesian trial designs, supporting more efficient, relevant, 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 […]

In this exclusive Discover Pharma interview, Sarah Tucker, Chief Operating Officer at Phastar, shares how the CRO is transforming clinical trials through flexible, data-driven delivery and patient-centric innovation. From decentralized models to Lean Six Sigma, she offers key insights into balancing speed with scientific rigor in today’s evolving trial landscape. ”As specialists in biometrics and […]

With major changes ahead for EU Health Technology Assessments (HTAs), including the introduction of joint clinical assessments from 2025, developers must adapt quickly to new regulatory expectations. In a recent article for PharmaPhorum, Stephen Corson, Associate Director, Statistics and Technical Solutions and Head of Statistical Consultancy at Phastar, outlines how developers can prepare for the […]

Phastar has been shortlisted for the Excellence in Clinical Trial Management category at the Fierce CRO Awards 2025. The award recognizes organizations that are redefining trial delivery through innovation, efficiency, and improved oversight. Our entry highlighted the impact of Phastar’s Clinical Intelligence platform, developed to support real-time oversight across complex trials by integrating operational, statistical, […]

In an exclusive feature for Contract Pharma, Phastar’s Head of Business Transformation and China General Manager, Ping-Chung Chang, examines how data sciences solutions including advanced analytics and data visualization are accelerating clinical development. He discusses the increasing complexity of clinical trials and how integrating real-time insights and AI-driven tools is transforming operations, enhancing recruitment, and […]

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 […]

At Phastar, we are passionate about accelerating the pace of clinical development through specialist biometrics and data science solutions, supporting our clients in their mission to improve human health. But as we work with our clients to develop better treatments, it is important to reflect on the impact our industry has on the planet. From […]

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 […]

Early-phase clinical trials play a critical role in drug development, particularly in determining the right dose and combination of treatments for later-stage testing. With the increasing complexity of combination therapies, traditional trial designs often struggle to keep pace.  In our recent webinar, Dr. Pavel Mozgunov (MRC Investigator, MRC Biostatistics Unit, University of Cambridge), Weishi Chen […]

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 […]

In an interview with The Clinical Trial Vanguard, Phastar CEO Graham Clark explores the evolving pharmaceutical landscape. He shares insights on the latest industry trends, highlighting the growing role of technology in clinical trials and the strategic advancements shaping drug development and trial management.

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 […]

Matthew Thompson, Associate Director, Statistical Programming at Phastar, authored a piece for Clinical Research News on how Real-World Evidence (RWE) is transforming drug development. He explores the benefits of RWE in hybrid trials, patient recruitment, and adaptive designs, as well as the challenges of working with Real-World Data (RWD).

As we mark International Women’s Day 2025, Phastar is calling for accelerated action toward gender equality in data and STEM fields. At the current pace, full gender parity won’t be reached until 2158, making it crucial for our industry to act now. While Phastar is proud that over 56% of our data experts are women, […]

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 […]

On Rare Disease Day, we highlight the potential of Bayesian statistics to overcome recruitment challenges in rare disease trials. In an article for ACRP Clinical Researcher, Giles Partington, Principal Statistician at Phastar, explores how incorporating prior data and expert judgment can reduce sample size requirements, improve efficiency, and increase trial success rates. ”There are between […]

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 […]

At SCOPE 2025, Phastar CEO Graham Clark spoke with Applied Clinical Trials (ACT) about the future of clinical trial optimization. Discussing Phastar’s Best in Show-winning Clinical Intelligence Portal, he highlighted how data science solutions such as AI-driven analytics and real-time insights are transforming trial oversight.  ” The first thing, the bedrock of everything, is rigorous data […]

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 […]

Elisa Mansfield, Vice President of FSP at Phastar, contributed an article to Pharmaceutical Outsourcing discussing the critical role of selecting the right FSP solution for biotech and biopharma organizations. She explored how these strategic partnerships can optimize quality, financial efficiency, and operational effectiveness. “By building good-standard partnerships, biotech, and biopharma companies can ensure they maximize […]

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, […]

Graham Clark, CEO at Phastar, spoke to PharmaVoice with his predictions on how AI and data science solutions will further transform the business of drug discovery and development this year. ”As AI, big data and digital health technologies become essential for trial design and patient recruitment, the demand for analytical and technical skills will likely […]

Graham Clark, CEO at Phastar, contributed to Clinical Research News on his predictions for clinical research in 2025. Clark highlighted the growing efficiency brought by AI but warned of a critical talent shortage in specialized roles like AI experts and data scientists. He urged the industry to upskill and adapt to new technologies to avoid […]

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, […]

Having completed an undergraduate degree in mathematics, Sarah Crossley joined the Phastar apprenticeship scheme in January 2024, where they are currently pursuing a master’s degree while working as a statistician. This apprenticeship scheme is distinct from the Phastar graduate program, which is designed for individuals who have recently graduated from an MSc or PhD. In […]

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 […]

Elisa Mansfield, Vice President FSP at Phastar contributed an article to European Pharmaceutical Contractor discussing the rise of a FSP solution to outsourcing, the advantages to this method and how to select the right strategic partner to optimize outsourcing for the greatest efficiency, quality and flexibility. ‘Outsourcing allows sponsors to reduce costs, gain specific domain […]

Vicky Marriott, Head of Statistics at Phastar recently spoke with Outsourcing Pharma for its Women in Science feature. In the exclusive interview she discusses her career to date, the challenges she has faced and how she wants to inspire the next generation of women in statistics. ‘I also had a preconception that you needed to […]

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 […]

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 […]

We are proud to announce that Phastar has improved its EcoVadis sustainability score, achieving a commendable 60 this year. This progress places us within the top 35% of companies, earning a prestigious bronze rating.   EcoVadis is a trusted global provider of business sustainability ratings, helping organizations measure and improve their impact on society and the […]

By Lucy Clark, Statistics Manager, and Barbara Arch, Senior Statistician.  The United States Food and Drug Administration (FDA) recently (September 2024) published a finalized guidance document on Conducting Clinical Trials with Decentralized Elements. [1] This document is aimed at sponsors, investigators, and other interested parties. Two of our expert statisticians at Phastar have summarized the […]

Elisa Mansfield, Vice President, FSP at Phastar, contributed an article for the October issue of Applied Clinical Trials titled ‘Implementing a Gold Standard FSP Strategic Partnership’. The article discusses how biotech and biopharma companies can make sure they choose the right FSP solution to maximize financial efficiency, quality, operational effectiveness, and overall success. ‘In a […]

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 […]

On this World Mental Health Day, Phastar stands in support of raising awareness and fostering open conversations about mental well-being. This year’s theme, “Time to Prioritize Mental Health in the Workplace,” underscores the critical importance of addressing mental health and well-being for the benefit of individuals, organizations, and communities.  At Phastar, we are dedicated to […]

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 […]

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 […]

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 […]

In Jack Jacobsen’s, Head of Data and Visual Analytics at Phastar, article with PM360 he explores how we can fully utilize data science solutions including visualization to unlock valuable insights in clinical trials and extract the maximum value from data. ‘The right tool can significantly enhance data understanding, insight discovery, communication, decision-making, efficiency, collaboration, data […]

Phastar CEO, Graham Clark, was interviewed by the editor of Outsourcing Pharma at the DIA Global Annual Meeting earlier in the year. Graham provided insights on the key trends and advancements shaping the industry today, including the role of AI and data science solutions in this transformation. “How the industry transitions away from dependence on […]

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 […]

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. […]

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 […]

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 […]

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 […]

In her article for BioSpectrumAsia, Professor Jennifer Visser-Rogers highlights ongoing gender inequality in the pharmaceutical industry, pointing out that despite women comprising over half of new entrants, they hold fewer leadership positions and face a significant pay gap, with stereotypes, biases, and childcare responsibilities hindering their career advancement. Prof Visser-Rogers points to solutions including awareness […]

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 […]

In this article for PharmaPhorum, Phastar’s Stephen Corson’s delves into the changing landscape of Health Technology Assessments (HTAs) in Europe. With the introduction of the EU-wide HTA regulation, there’s a shift towards a unified approach to evaluating new therapeutic products and medical devices. This change aims to harmonize and streamline the post-regulatory approval adoption process […]

Complete the form below to watch the webinar Featuring: Moderated by Natalie Fforde, Senior Vice President, Global Strategic Partnerships, Phastar

Slides created by: Carly Baker, Director, Clinical Data Operations, and Kat Fogden, Principal Data Operations Programmer | Phastar Complete the form below to download the slides

In his article for Applied Clinical Trials, Ping-Chung Chang’s highlights the rapid evolution of clinical trials driven by the rise of Hybrid and Decentralized Clinical Trials (DCT). As clinical trials increasingly rely on technology for data collection, new challenges and opportunities emerge for the clinical research workforce. Read the full article in Applied Clinical Trials.

Presented by: LaRee Tracy, PhD, and Joshua Baker, PhD Complete the form below to watch the webinar

In this article for PharmaTimes Magazine, Phastar’s Elisa Mansfield discusses the rising popularity and benefits of the Functional Service Provider (FSP) model in the pharmaceutical industry. With growing complexities in clinical trials and increasing demands for expertise, the FSP model allows sponsors to engage specialized services when needed. Read the full article in PharmaTimes Magazine.

In this article for ACRP Clinical Researcher, Professors Deborah Ashby and Jennifer Visser-Rogers discuss the challenges of data monitoring in complex clinical trials. Traditional methods are insufficient for trials with multiple variables like endpoints or treatments. Emphasising the importance of adaptable Data Monitoring Committees (DMCs) and collaboration among experts to handle these complexities effectively Prof Ashby and […]

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Professor Deborah Ashby, Interim Dean of the Faculty of Medicine, Imperial College, recently presented Phastar’s annual Sally Hollis Memorial Lecture. In this Q&A for Outsourcing Pharma, Professor Ashby and Professor Jennifer Visser-Rogers, Vice-President for Statistical Research and Consultancy at Phastar, discuss how new approaches to clinical trials are changing data monitoring committees. Read the full Q&A at Outsourcing-Pharma.com.

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Authors: Giles Partington, Sarah Simpson, Lauren Rojas, Emily Foreman, Ian Wadsworth. Bayesian statistics is one of the two main fields of thought for statistics. Whilst the more familiar frequentist statistics focuses on observing events to attempt to disprove a null hypothesis at a specific p-value and power; Bayesian statistics uses the ideas behind Bayes theorem […]

The European Medical Association (EMA) defines “rare diseases” as diseases that affect fewer than 5 in 10,000 people;[1] whereas small population trials are those looking at a specified subset of the population that are of interest within a trial, such as patients with a more common ailment but who cannot be maintained effectively by current […]

About this webinar The application of expert prior elicitation in clinical research serves as an important methodological tool to quantify expert knowledge into the definition of prior probability distributions, which can be leveraged to inform Bayesian study design, enhance decision making, and ultimately advance the quality of patient care. In this webinar recording, our panel […]

In her article for Applied Clinical Trials, Professor Jennifer Visser-Rogers explores the evolving relationship between contract research organizations (CROs) and sponsor partners in the pharmaceutical industry. She discusses how CROs have expanded their capabilities to support sponsors in various aspects of clinical trials, emphasizing the shift towards strategic partnerships and the increasing reliance on specialized […]

A great turnout of members from the Phastar family, together with guests from the wider community, gathered in Macclesfield for an evening of education, commemoration, and celebration at the third annual Sally Hollis Memorial Lecture event. This year’s lecture was delivered by Professor Deborah Ashby, Interim Dean of the Faculty of Medicine at Imperial College, […]

Navigating Clinical Monitoring Challenges For over a decade, Phastar has been at the forefront of the clinical monitoring domain, delivering tailored solutions to numerous pharmaceutical and biotech companies. Our extensive experience spans more than 20+ therapeutic areas and over 100 distinct clinical trials, revealing recurring challenges in clinical monitoring In this article, we shed light […]

In this article for Clinical Research News, Andrew MacGarvey explores the transformative potential of big data analytics in the pharmaceutical and healthcare industries. From ensuring patient population diversity to advancing AI and machine learning technologies, analytics is reshaping clinical trial efficiency. Read the full article at Clinical Research News.

Author: Professor Deborah Ashby Interim Dean of the Faculty of Medicine, Imperial College London About the lecture  During a clinical trial, accruing data is often seen in confidence by a data monitoring committee to evaluate whether early termination of the study or other modifications are needed in the light of emerging results. For a classical […]

In this article for the Journal for Clinical Studies, Pamela Adede delves into the challenges posed by missing data in clinical trials amid the rise of Digital Health Technologies (DHTs). While DHTs promise enhanced efficiency and patient-centricity, they also introduce complexities in data collection. Read the full article in the Journal for Clinical Studies.

In this article for ICT Summer 2023, Professor Jennifer Visser-Rogers highlights the importance of collaborative efforts across the life sciences ecosystem to address the challenges facing modern healthcare. Read the full article in the International Clinical Trials/EPC’s Women in Pharma 2023 supplement.

Authors: Giles Partington, Lindsay Govan, Paddy O’Hara, Emily Foreman, and Jennifer Visser-Rogers | Phastar Abstract A key challenge in drug development for rare disease is difficulty in obtaining relevant data due to a lack of suitable trial participants for each specific condition. Conservative estimates suggest there are 300 million people worldwide living with more than […]

In this article, Phastar’s Nicola Griffiths emphasizes the pivotal role of data science in managing the increasing complexity of clinical trial data. With the rise in data volume and sources, data scientists assist in prioritizing and cleaning data efficiently, enabling a risk-based approach that saves time and resources. To understand more about this evolving landscape […]

Phastar’s Carly Baker, Director of Clinical Data Management, and Alice Wang, Principal Data Scientist, recently took part in a Data Management-focused Q&A for the ACRP’s Clinical Researcher June 2023 release (Volume 37, Issue 3). In a wide-ranging discussion the pair touch on the benefits of IDMCs in safeguarding participant safety and ensuring data integrity, as well […]

Stephen Corson, Statistics Manager at specialist biometrics contract research organization (CRO) Phastar, has been chosen to receive the DIA 2023 Global Inspire Award for Community Engagement. This prestigious award recognises the outstanding contribution of DIA Community Chairs who consistently drive engagement and promote knowledge sharing, while advancing thought leadership within the membership community. Stephen commented: […]

Digital Health Technologies (DHTs) are democratizing data collection during clinical trials, while promising to make research more efficient and more patient centric. However, shifting the power to input data from clinicians to participants, increases the risk of missed datapoints. Where it occurs, this data sparsity can lead to incomplete submissions, threatening the success of otherwise […]

The experience across the team at Phastar is rich and varied and on average the technical team has over 14 years’ experience, which is a wealth of knowledge that brings huge benefits to our clients. The team are not only experts working with data but also the analytics of that data to deliver value. The […]

Currently, there is no widely adopted definition of Digital Health. At Phastar, we take a broad view and refer to Digital Health as the “use of technology in healthcare”, as it encompasses the use of computing platforms, connectivity, software, artificial intelligence, machine learning, and sensors for health care and related uses. Just 20 years ago, […]

COVID-19 and its subsequent variants have provided challenges in many ways, not the least of which are in the conduct and management of clinical trials. Global quarantines and disruptions in investigational product supply, patient recruitment and sustainability have been major concerns in an era when it’s more important than ever to proceed with drug development. […]

Presented by: Professor James Carpenter | MRC Clinical Trials Unit, LSHTM Complete the form below to watch the webinar

Presented by: LaRee Tracy, PhD, and Joshua Baker, PhD Complete the form below to watch the webinar

Presented by: LaRee Tracy, PhD, and Joshua Baker, PhD Complete the form below to watch the webinar

Presented by: Jordan Bristow | Phastar Complete the form below to watch the webinar

Presented by: Lucy McParland | Phastar Complete the form below to watch the webinar

Phastar statistician Ian Wadsworth had a research article published in Statistical Methods in Medical Research examining modelling approaches for quantifying how exposure-response parameters vary over different ages in paediatric populations. Here he summarises the methodologies considered: Within paediatric populations, different age groups of children treated with a new medicine may experience differences in dose–exposure and […]

Presented by: Kirsty Millar | Phastar Complete the form below to watch the webinar

A common question in clinical research is whether a new method of measurement is equivalent to an established one. As a statistical consultant at Phastar, I am seeing an increase in the number of trials where a new artificial intelligence or machine learning diagnostic tool is being compared to either a pre-existing tool, or to […]

Real world evidence (RWE) in medicine is the clinical evidence regarding the use and potential benefits or risks of a medical product derived from the analysis of real-world data (RWD). RWD are effectively data collected from outside of a clinical trial and that relate data to the patient health status and/or the delivery of health […]

When developing a new medicine for children, the potential to extrapolate from adult efficacy data is well recognised. Extrapolation can be used to streamline drug development, with the European Medicines Agency (EMA) defining extrapolation as: “… extending information and conclusions available from studies in one or more subgroups of the patient population (source population) … […]

There has been a growing emergence in the utilisation of basket studies and it’s not difficult to see why. Progress in genomics, tumour biology and statistics has led to advances in “precision oncology”. Cancers that were once viewed as homogeneous in terms of location and treatment strategy are now better understood to be increasingly heterogeneous […]