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  This webinar brings together three regional perspectives on the current regulatory landscape: the FDA’s draft guidance on Bayesian statistics, China’s CDE guidance on Bayesian approaches, and Bayesian-relevant expectations […]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 […]

How Regulators Evaluate Evidence in a Changing Data Landscape  As clinical research evolves, causal inference is playing an increasingly important role in regulatory decision-making. With this shift comes challenges, particularly when balancing scientific rigor with real-world applicability.  A key takeaway from our expert discussion: causal inference should be incorporated from the very beginning of a study. Starting with a well-defined research question leads to clearly outlining the goal […]

The Functional Service Provider (FSP) model has long been a cornerstone of clinical development outsourcing. Originally conceived as a tactical staffing solution, it offered sponsors a straightforward way to extend internal teams and access specialist capabilities. But as clinical development has grown more complex, data-intensive, and globally distributed, the expectations placed on FSP partnerships have […]

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, […]

Clinical trial oversight depends on the ability to access, interpret, and act on data quickly. Many organizations still face challenges with fragmented systems, delayed insights, and inefficient processes. Integrated analytics provides a more effective approach by combining data, technology, and expertise.  The growing challenge of complexity  Clinical trials have become significantly more complex over the past decade. […]

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 […]

Clinical trials are generating more data than ever before, but more data does not automatically lead to better decisions. The challenge for pharmaceutical and biotech organizations is turning complex, fragmented datasets into clear, actionable insights.  Data visualization is playing an increasingly important role in addressing this challenge. By presenting clinical, operational, and safety data in intuitive, real-time formats, teams […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 product in facioscapulohumeral muscular dystrophy (FSHD), spanning 30 trials across Phase I–III and multiple indications.  Key Challenges:  Our Approach:  Outcome: Phastar successfully delivered over 500 high-quality outputs within 10 months. The ISS was ready for regulatory submission, with a clear, standardized […]

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 […]

When a top 20 global pharmaceutical company issued a competitive RFP seeking support in statistical programming and data management, Phastar was selected as a trusted FSP partner. Since 2020, the partnership has grown significantly, with over 100 Phastar professionals now supporting global clinical research efforts across multiple therapeutic areas. Case Study Highlights: Entering its sixth […]

A new predictive tool built from NHS data helps identify patients most at risk of kidney disease and retinopathy. It supports earlier, more personalized care. See how it’s helping clinicians address health inequities and use resources more effectively. Complete the form below to read the full case study

Introduction  Patient reported outcomes (PRO) have been used in clinical trials for many years, but it is only recently that electronic (ePRO) collection has become possible. The advantage for trials is the potential for on-the-spot measurement of endpoints that are characterized as a set of symptoms, reportable by patients. This decentralized data collection has the […]

Real-world evidence (RWE) is rapidly transforming how clinical trials are designed, evaluated, and approved. In Phastar’s latest webinar, part of our new biotech-focused series, Principal Data Scientist Tasos Mangelis provided an in-depth look at the evolving RWE landscape, highlighting the opportunities, challenges, and practical applications of real-world data (RWD) in clinical development.  The Rise of […]

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 […]

Delays in patient recruitment can derail even the most well-designed clinical trials. Discover how Phastar’s Recruitment Forecasting app helped a global biopharma company stay ahead of enrolment challenges by using advanced analytics to predict trial completion and optimize patient allocation. Complete the form below to read the full case study

London, UK, and Durham (NC), US – April 10th, 2025: Phastar, a global specialist biometrics & data science Contract Research Organization (CRO), has been shortlisted in ‘CRO Partnership of the Year’ category at the 2025 Citeline Awards for its collaboration with Medicines Development for Global Health (MDGH), a not for profit pharmaceutical company dedicated to […]

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 […]

A customer managing a high-profile clinical trial faced significant challenges due to their reliance on Excel for trial monitoring. The process was manual and labor-intensive, and their newly implemented Electronic Data Capture (EDC) system lacked an automatic data extraction module. This made it difficult to manage and analyze data in real time, affecting trial oversight […]

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.

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 […]

London, UK, and Durham (NC), US – February 13th, 2025: Phastar, a global specialist biometrics & data science contract research organization (CRO), won a Best of Show Award at Summit for Clinical Ops Executives (SCOPE) US 2025. Having taken place in Orlando, Florida from the 3rd-6th February, SCOPE’s 300+ attendees voted on more than 60 product […]

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 […]

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  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 […]

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 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 […]

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 […]

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 […]

High quality data visualisation and advanced recruitment forecasting app shapes success story in Best Sponsor Facing Initiative London, UK, and Durham (NC), US – 25th March 2024: Phastar, a global specialist biometrics contract research organization (CRO), has been selected as finalist for the Best Sponsor-facing Technology Initiative at the Citeline Awards 2024. Phastar were recognised for the launch of their Clinical Intelligence […]

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 […]

This project was a collaboration between Kopenhagen Konsulting and Phastar Denmark. KK Management Konsulting lead the project and report/metric definitions. Phastar Denmark developed and implemented the technical solution. They wanted to automate the process of pulling data reports from multiple systems, calculate various metrics, and create automated visualizations of the figures on a monthly basis. […]

London, UK and Cambridge, MA – June 24, 2019 – Phastar announced today that it has entered into a technology partnership with Medidata Solutions, Inc.. Phastar will deploy several solutions from the Medidata Rave Clinical CloudTM including Rave EDC, Coder, eCOA, and RTSM. The adoption of the Medidata Rave Clinical Cloud comes as Phastar continues […]