Estimands have become a central concept in modern clinical trials, particularly in oncology, where treatment pathways are complex and patient outcomes can be influenced by many post-randomization events. At their core, estimands force us to be explicit about the exact question a trial is trying to answer which has not always been clearly defined in […]

Interim analyses and safety reviews play a critical role in clinical trial oversight, providing decision-makers with timely insights while safeguarding study integrity.  In this Phase II breast cancer study, we supported three safety review committees and a formal interim analysis, delivering validated statistical outputs, independent statistical oversight, and secure management of blinded and unblinded data.  […]

From unlocking new insights to making clinical developments more relevant to people across the world, advanced statistical methods are transforming clinical trials. We interviewed four of the women leading innovation here at Phastar, Hebing Wang (Principal Statistician, China), Samantha Hinsley (Statistics Manager, UK), Helen Marshall (Principal Statistician, UK), and Vicky Marriott (Head of Statistics and […]

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 […]

Designing a first-in-human study is challenging. Designing one for a novel reproductive therapy with limited prior data and significant biological variability is even more complex.  In this case study, discover how Phastar partnered with an innovative biotechnology company developing a groundbreaking therapeutic aimed at improving IVF success rates through the reduction of chromosomal errors in […]

Accelerating clinical development requires more than speed, it demands a careful balance between innovation, scientific rigor, and regulatory confidence.  In this case study, discover how Phastar partnered with a biotechnology company to develop an ambitious seamless Phase 2b/3 clinical trial strategy designed to support a critical FDA Type C meeting and accelerate progression into Phase […]

Helping an Emerging Biotech Navigate Complex Clinical Development Preparing for a first-in-human clinical trial presents significant challenges, particularly for emerging biotech companies with limited clinical experience, constrained patient populations, and the need to satisfy regulatory expectations. Phastar partnered with a biotechnology company developing an early-phase oncology program to design a robust dose-finding study that would […]

Demonstrating real-world value is critical for securing pricing and market access, but bridging the gap between clinical trial efficacy and real-world outcomes can be complex, particularly under HTA scrutiny. Download our case study to learn how advanced modelling and real-world evidence can quantify treatment impact, support pricing negotiations, and drive commercial success.  What You’ll Learn  […]

Biopharma organizations have access to vast amounts of real-world data, but extracting meaningful, actionable insights across multiple diseases and populations remains a major challenge. Traditional approaches are heavily manual, limiting scalability and slowing the ability to identify new opportunities.  Download our case study to learn how an AI-powered biometrics framework transforms real-world evidence into a […]

Demonstrating short-term efficacy is no longer enough, regulators increasingly require a clear understanding of long-term outcomes and benefit–risk balance. Translating Phase 3 trial data into long-term, real-world insights remains a major challenge, particularly when evaluating trade-offs between disease progression and treatment-related adverse events. Download our case study to learn how advanced modelling and simulation approaches […]

Understanding disease progression in complex, heterogeneous conditions like Huntington’s Disease is critical to designing successful clinical trials, but variability and small patient populations make this extremely challenging. Download our case study to learn how advanced data science and predictive modelling can uncover hidden patterns, improve patient stratification, and increase the probability of trial success.  What […]

How can pharmaceutical companies uncover new value from existing therapies without the cost and risk of developing new drugs from scratch? In this case study, discover how a leading pharmaceutical organization partnered with Phastar to apply AI and real-world evidence (RWE) to identify promising new indications for approved therapies in multiple sclerosis and related autoimmune […]

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 […]

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 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:

Phastar partnered with a biotechnology sponsor to manage statistical and data management activities for a late-stage clinical study in Parkinson’s disease. The project involved distributed teams, complex neurosurgical procedures, and questionnaire-driven endpoints—all under tight budget oversight.  Key Challenges:  Our Approach:  Outcome:  The study progressed smoothly, earning strong praise from all stakeholders. The sponsor commended Phastar’s professionalism, attention […]

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 […]

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

Discover how Phastar converted 16 legacy studies into SDTM and delivered a robust Integrated Summary of Safety (ISS) for a Multiple Sclerosis Spasticity program. Despite inconsistent legacy data, outdated coding, and complex integration requirements, Phastar applied structured methodology, proactive issue resolution, and harmonized integration to deliver clean, compliant, submission-ready datasets. Complete the form below to […]

A sponsor needed to pool data from four MS spasticity studies—one still ongoing with another vendor—while adapting mid-project to a new SDTM-level pooling strategy. Unique baseline derivations, advanced analyses, and regulatory expectations added further complexity. SolutionPhastar introduced a modular workflow separating statistical analysis from TFL production. This streamlined process reduced run times, improved efficiency, and […]

Phastar acted as the Independent Data Analysis Centre (IDAC) for a Phase III trial in thrombotic microangiopathy (TMA) after HSCT. With 13 DMC meetings, ad hoc analyses, and tight budget constraints, our team ensured secure data sharing, expert review, and streamlined workflows—delivering high-quality results while controlling costs. Download the full case study to explore the […]

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: 

Interim analyses in Phase III trials are high-stakes and often come with evolving requirements and tight timelines. When frequent revisions and compressed schedules created additional challenges, Phastar partnered with the sponsor to deliver clarity, accuracy, and confidence.  Key challenges included:  Phastar’s tailored solutions:  Complete the form below to read the full case study

Navigating multi-therapeutic Phase III studies is complex. From strict blinding protocols to scheduling senior DMC members across multiple time zones, the challenges are significant. Phastar’s tailored approach ensures that every deliverable is managed efficiently, securely, and with the highest statistical rigor.  Key highlights from our case study:  Complete the form below to read the full […]

Integrating efficacy and safety data across multiple studies is never simple—especially when patient-reported outcomes, complex study designs, and multiple safety populations are involved.  In this case study, see how Phastar partnered with a global sponsor to deliver both an Integrated Summary of Efficacy (ISE) and an Integrated Summary of Safety (ISS) for a treatment targeting […]

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 […]

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 […]

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 […]

How Phastar Rescued 12 Studies and Became a Long-Term Strategic Partner. Discover how Phastar stepped in to rescue multiple high-stakes oncology trials following quality failures from a previous vendor — restoring data integrity, meeting tight regulatory deadlines, and delivering fully validated outputs. Download the full case study to explore the approach, outcomes, and lasting impact. […]

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 […]

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 […]

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 […]

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 […]

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

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.

London, UK and Durham, NC – January 23rd, 2024: Phastar, a global specialist biometrics contract research organization (CRO), has announced the launch of Stats Helpdesk, a new initiative designed to provide biotech companies with free access to its team of expert statisticians. The Stats Helpdesk initiative offers essential support and guidance tailored to address the statistical questions […]

In our final blog of the series, we examine the impact of missing data caused by the COVID-19 pandemic on clinical trials. It is generally accepted that there will be an increased amount of missing data in most clinical trials due to the COVID-19 pandemic. Missing data should be anticipated and the appropriate methods of […]

In our latest blog of the series, we examine the topic of estimands with respect to clinical trials affected by the COVID-19 pandemic. When evaluating whether the primary objective of the trial is affected by the pandemic, it is necessary to consider the treatment effect in the absence of the COVID-19 pandemic and not confounded […]

In this blog series, we examine the impact of COVID-19 on the conduct, analysis, and interpretation of ongoing clinical trials. The safety of trial participants and all staff involved remains the primary concern in all clinical trials. The key message has always been (and remains) that clinical trials are critical and should continue during the […]

Throughout this blog series, we will be discussing how the COVID-19 pandemic situation has affected clinical trials, focussing on the pertinent statistical issues and associated key recommendations. Rather than providing an exhaustive summary of all potential issues and possible solutions, the aim is to concentrate on the key areas and questions that statisticians on project […]

When the World Health Organisation (WHO) declared the COVID-19 pandemic on 11th March 2020, countries the world over implemented restrictions to manage this accordingly. As well as challenges faced by people and communities around the globe, the pandemic presented unique challenges for the clinical trials community, with many existing studies being either temporarily paused and […]

Phastar was contracted to assist a pharmaceutical company with the conversion of 16 legacy studies to SDTM (2 SDTM “Like” phase II studies, 14 Legacy Phase I studies) and with the pooling and reporting activities of their Integrated Summary of Safety (ISS) for a regulatory submission. It has been quite a challenging project but one […]

Phastar was contracted to assist a global pharmaceutical company with their integrated summary of safety and efficacy for a regulatory submission. The work started with assisting the sponsor in defining an integration strategy for approximately 20 phase I studies, six phase II studies and their corresponding extension as well as three phase III studies and […]

Phastar provided a team of statisticians and programmers to deliver the analysis and reporting of a program of four trials in a genetic rare disease, and the corresponding integrated summary of efficacy and safety, to support a regulatory submission to the FDA. There were four studies comprising twelve, one, two, and three patients. The one […]

Case study PHASTAR was engaged to report a phase I/II oncology study in advanced NSCLC with an initial phase I escalation followed by a phase II expansion. The objectives covered defining the maximum tolerated dose and having a preliminary assessment of efficacy using RECIST 1.1 as well as PK/PD endpoints. For this study, PHASTAR was […]

I started out my university experience by going to Dundee to study mathematics, this was mainly a theoretical degree with the occasional statistic module in the first two years. Once I was in my fourth year, I decided I wanted to focus on the more practical aspect of mathematics. After looking around I found this […]