Blogs

Estimands have become a central concept in modern clinical trials, particularly in oncology, where treatment pathways...

In oncology trials, we rely heavily on two time-to-event endpoints: progression-free survival (PFS) and overall survi...

Choosing a clinical data management CRO can feel challenging when many providers make similar claims about quality, c...

From unlocking new insights to making clinical developments more relevant to people across the world, advanced statis...

Progression-free survival (PFS) offers sponsors the opportunity to assess treatment benefit earlier than overall surv...

Strong partnerships and specialist expertise are key to the success of any Functional Service Provider (FSP) model. T...

Oncology is a rapidly developing and expanding area of therapeutic development with more new drugs and supplemental i...

In our “Meet the Team” series, we highlight the talented individuals who drive Phastar’s success. Each te...

As the functional service provider biometrics model evolves, so too must the way sponsors measure its success. Tradit...

In our “Meet the Team” series, we highlight the talented individuals who drive Phastar’s success. Each te...

As clinical trials become more complex, global, and data-intensive, biopharma organizations are under pressure to del...

How Regulators Evaluate Evidence in a Changing Data Landscape  As clinical research evolves, causal inferen...

The Functional Service Provider (FSP) model has long been a cornerstone of clinical development outsourcing. Original...

In our “Meet the Team” series, we highlight the talented individuals who drive Phastar’s success. Each te...

Clinical trials are inherently complex, with risks emerging across data quality, patient safety, site perfo...

Understanding cause and effect is often of interest when conducting research, but in practice it is rarely ...

Clinical trial oversight depends on the ability to access, interpret, and act on data quickly. Many organizations sti...

Can you tell us a bit about your background and what led you to work with Phastar?  I completed my MMath de...

Clinical trials are generating more data than ever before, but more data does not automatically lead to better decisi...

In our “Meet the Team” series, we highlight the talented individuals who drive Phastar’s succes...

In clinical research and real-world evidence generation, one of the most common scientific questions we face is decep...

In our “Meet the Team” series, we highlight the talented individuals who drive Phastar’s succes...

Causal inference begins with clarity about the research question. What population, treatment, comparator, and outcome...

As we mark B Corp Month 2026, Phastar is reaffirming its commitment to building a purpose-driven organization where p...

Early-phase oncology trials are increasingly exploring combination therapies to improve outcomes for patients with co...

Real-world data (RWD) can provide insight into benefits, risks and usage of medical pro...

In our “Meet the Team” series, we highlight the talented individuals who drive Phastar’s success. Each te...

Progress in our industry is often measured in milestones, approvals, data readouts, and regulatory submissi...

Introduction  As regulatory demands intensify, the challenge for sponsors is not just to produce SDTM-compliant data,...

You were among the first to submit and defend a Bayesian trial design to the FDA around 20 years ago. How were Bayesi...

Can you tell us a bit about your background and what led you to join Phastar?   I hold an M.S. in Statistic...

The landscape of early-phase clinical research continues to evolve rapidly. As new therapeutic modalities emerge...

On the 12th January  2026 the FDA brought out recommended guidance on the use of Bayesian methods, this marks the fir...

Statistics sit at the heart of every early-phase clinical trial. From dose escalation to determining the Ma...

In our “Meet the Team” series, we highlight the talented individuals who drive Phastar’s success. Each te...

Introduction  In today’s data-driven clinical research environment, regulatory authorities expect structured, traceab...

Designing an early-phase clinical trial is one of the most important, and most complex, steps in drug development. Th...

In our “Meet the Team” series, we highlight the talented individuals who drive Phastar’s success. Each te...

The early stages of clinical development are critical, and the decisions made here determine not only the efficiency ...

In our “Meet the Team” series, we highlight the talented individuals who drive Phastar’s success. Each te...

Introduction  Data Monitoring Committees (DMCs) play a pivotal role in protecting the rights, safety and well-be...

By Billy Amzal, Head of Strategic Consulting, Phastar  Introduction  Rare disease research demands tailored...

Introduction A Data Monitoring Committee’s (DMC) overriding responsibility is to protect the rights, safety and well-...

Introduction  Integrated Summaries of Safety (ISS) and Effectiveness (ISE) bring together data from across clini...

In our “Meet the Team” series, we highlight the talented individuals who drive Phastar’s success. Each te...

Introduction   When preparing a regulatory submission, one of the most critical components is the Integrated Saf...

Introduction Real-world data (RWD) can provide insight into treatment effects in a real-world setting. However, becau...

In our “Meet the Team” series, we highlight the talented individuals who drive Phastar’s success. Each te...

In our “Meet the Team” series, we highlight the talented individuals who drive Phastar’s success. Each te...

Smooth collaboration and effective integration between clinical data management (CDM) and biostatistics does not happ...

Phastar recently welcomed Billy Amzal as Head of Strategic Consulting. A statistician, public health scientist, and e...

When Clinical Data Management (CDM) and biostatistics teams collaborate from the outset of a trial, the impact is tra...

As clinical trials become more complex and data-driven, pharmaceutical and biotech companies are increasingly seeking...

In our “Meet the Team” series, we highlight the talented individuals who drive Phastar’s success. Each te...

Introduction  Randomized Controlled Trials (RCTs) remain the cornerstone of evidence generation in clinical rese...

In our “Meet the Team” series, we highlight the talented individuals who drive Phastar’s success. Each te...

Introduction  Patient reported outcomes (PRO) have been used in clinical trials for many years, but it is only r...

Real-world evidence (RWE) is rapidly transforming how clinical trials are designed, evaluated, and approved. In Phast...

Phastar has been shortlisted for the Excellence in Clinical Trial Management category at the Fierce CRO Awards 2025. ...

Introduction  Real-world data (RWD) plays a crucial role in medical research, providing valuable insights from a...

In our “Meet the Team” series, we highlight the talented individuals who drive Phastar’s success. Each te...

Introduction  In clinical research, selecting the most effective treatment can be challenging, especially when m...

At Phastar, we are passionate about accelerating the pace of clinical development through specialist biometrics and d...

Early-phase clinical trials play a critical role in drug development, particularly in determining the right dose and ...

In our “Meet the Team” series, we highlight the talented individuals who drive Phastar’s success. Each te...

In the evolving landscape of clinical trials, data monitoring has traditionally been a one-way street, data flows fro...

Introduction   Our webinar explored the use of expert prior elicitation techniques in clinical research, pa...

Introduction  For biotechs looking to advance clinical development, selecting the right CRO partner can be a def...

During our recent webinar, we brought together key industry leaders to discuss the evolution and strategic value of F...

Introduction Integrating Real-World Data (RWD) and Real-World Evidence (RWE) into clinical research is gaining signif...

Introduction  In today’s fast-evolving environment, biotechs need to form strategic partnerships to address reso...

Real-World Evidence (RWE) is redefining how healthcare and drug development insights are generated. This blog explore...

Introduction  The biotech industry has become a driving force in clinical research, accelerating advances in are...

The implementation of the New Health Technology Assessment (HTA) framework in Europe is a pivotal moment for the regi...

Real-world data (RWD) and real-world evidence (RWE) are transforming the clinical research landscape. During our rece...

Introduction  Phastar’s recent webinar, “Implementing a Gold Standard FSP Strategic Partnership to Fuel Ef...

Having completed an undergraduate degree in mathematics, Sarah Crossley joined the Phastar apprenticeship scheme in J...

Introduction  The EU Health Technology Assessment (HTA) is set to undergo significant transformation at the begi...

Introduction Health Technology Assessments (HTA) are a vital process within healthcare systems, evaluating the value ...

Introduction  Risk-Based Quality Management (RBQM) has emerged as a powerful tool for optimizing clinical trial ...

Our recent webinar explored the complexities of Health Technology Assessments (HTA), their current role in evaluating...

We are proud to announce that Phastar has improved its EcoVadis sustainability score, achieving a commendable 60 this...

By Lucy Clark, Statistics Manager, and Barbara Arch, Senior Statistician.  The United States Food and Drug Admin...

Introduction  Risk-Based Quality Management (RBQM) is revolutionizing the way clinical trials are managed, offer...

On this World Mental Health Day, Phastar stands in support of raising awareness and fostering open conversations abou...

In the dynamic world of clinical research, selecting the right Contract Research Organization (CRO) partner is more i...

In the rapidly advancing world of clinical trials, data visualization plays a transformative role by enhancing effici...

Since the introduction of Project Optimus by the FDA in 2020 [1], it has become more important than ever to ensure th...

Psoriasis is an inflammatory disease characterised by lesions on the skin and has a prevalence of around 2% in the gl...

The landscape of clinical trials is undergoing a significant transformation, driven by rapid advancements in technolo...

Managing clinical trials is no easy task, with a range of challenges that can impact the success of a study. To gain ...

Introduction Project Optimus marks a major advancement in optimizing patient outcomes in oncology. By prioritizing do...

Introduction With the launch of Project Optimus, the FDA is overhauling the paradigm of dose optimization and selecti...

Introduction The Project Optimus initiative is a key part of the U.S. Food and Drug Administration (FDA’s) Onco...

By Michael Willis, MSc, Senior Statistician, and Lisa Gibbons, MSc, Senior Statistician Introduction The landscape of...

Introduction With the launch of Project Optimus, the FDA aims to reform the dose optimization and dose selection para...

By Wei Liu, PhD, Associate Director, Biostatistics, and Gillian Armstrong, MSc, Consultant Statistician The FDA recen...

By Tina Hovey, Principal Statistician, and Gillian Armstrong, Consultant Statistician, Phastar The FDA recently publi...

Medical monitoring is one of the most important aspects of any clinical trial, but traditional approaches are time-co...

Introduction An abundant problem in clinical trials is the absence of data due to patients prematurely withdrawing fr...

Phastar is providing pro-bono support to Medicines Development for Global Health (MDGH) as part of its Phastar CARES ...

Season’s Greetings from the Phastar team! Each year Phastar holds an internal competition among its programmers...

Authors: Giles Partington, Sarah Simpson, Lauren Rojas, Emily Foreman, Ian Wadsworth. Bayesian statistics is one of t...

The European Medical Association (EMA) defines “rare diseases” as diseases that affect fewer than 5 in 10,000 people;...

A great turnout of members from the Phastar family, together with guests from the wider community, gathered in Maccle...

Case report forms (CRFs) are critical in clinical trials as they capture vital data related to patient safety, treatm...

There is always an excited buzz around one or two hot topics at statistics conferences, and PSI 2023 was no exception...

Digital Health Technologies (DHTs) are democratizing data collection during clinical trials, while promising to make ...

Phastar embarked on a collaboration project with Ishango.ai to work on a data science project to automate the medical...

Phastar recently embarked on a collaboration with Ishango.ai to host two aspiring data scientists to work on an innov...

In a previous blog post, we described how, as part of the Centre for Analytical Excellence, Phastar delivered a proje...

As part of the Centre for Analytical Excellence, we recently delivered a challenging yet enjoyable project looking at...

Currently, there is no widely adopted definition of Digital Health. At Phastar, we take a broad view and refer to Dig...

COVID-19 and its subsequent variants have provided challenges in many ways, not the least of which are in the conduct...

In our final blog of the series, we examine the impact of missing data caused by the COVID-19 pandemic on clinical tr...

In our latest blog of the series, we examine the topic of estimands with respect to clinical trials affected by the C...

In this blog series, we examine the impact of COVID-19 on the conduct, analysis, and interpretation of ongoing clinic...

Throughout this blog series, we will be discussing how the COVID-19 pandemic situation has affected clinical trials, ...

When the World Health Organisation (WHO) declared the COVID-19 pandemic on 11th March 2020, countries the world over ...

FSP (Functional Service Provision) is fairly common in the United States and Europe, where many of the world’s ...

Introduction An IDMC (sometimes known as a DMC/DMEC/DSMB) is an Independent Data Monitoring Committee, whose role it ...

The crucial role of clinical data management (CDM) in a successful clinical trial is well understood, and central to ...

Functional Service Provision (FSP) and Full- Service outsourcing models have been hotly debated topics over the past ...

A common question in clinical research is whether a new method of measurement is equivalent to an established one. As...

Real world evidence (RWE) in medicine is the clinical evidence regarding the use and potential benefits or risks of a...

At a conference, the results of a clinical trial demonstrate that a new medicine is efficacious and safe for a partic...

I started out my university experience by going to Dundee to study mathematics, this was mainly a theoretical degree ...

When developing a new medicine for children, the potential to extrapolate from adult efficacy data is well recognised...

When designing a clinical trial, one of the biggest factors that needs to be thought about is blinding. In clinical t...

Starting a career in industry can be a daunting experience at any time of life, but especially when it is your first ...

I am now one year into my graduate role at Phastar, and it has been one of the quickest years of my life. I joined Ph...

The volume of digital data in healthcare is projected to increase more rapidly in the coming years than any other sec...

There has been a growing emergence in the utilisation of basket studies and it’s not difficult to see why. Progress i...

Traditionally, studies have been run with a process of study design, study conduct, study report. Whilst this is more...

There is considerable hype surrounding Machine learning (ML) and Artificial Intelligence (AI) yet despite that, these...

In medical research, information on the outcomes of a treatment may be available from a number of clinical studies wi...

Integration of data from a number of clinical trials for an Integrated Summary of Safety (ISS) and Efficacy (ISE) req...

Data quality and integrity are key aspects of Good Clinical Practice (GCP) and sponsors are expected by regulators to...

It has become easier to produce customised graphics in SAS and to produce reports that combine outputs from several d...

Understandably, there is considerable excitement around the field of data science particularly in relation to healthc...

The FDA defines an adaptive design as …an adaptive design is defined as a clinical trial design that allows for prosp...

A key objective of Phase I dose escalation trials is to establish a recommended dose and/or schedule for an experimen...

Recently, an FDA industry guidance draft on “Multiple Endpoints in Clinical Trials”1 provided an overview of multipli...

The public consultation period for the ICH E9 (R1) addendum on estimands and sensitivity analyses to the guideline on...

A rare disease is defined by the European Union as one that affects less than 5 in 10,000 of the general population a...

How do you define the importance of data quality in clinical trials? An accurate reflection of a subject’s experience...

Quality is paramount to all programming work carried out at Phastar to ensure accurate reporting and analysis of clin...

Data managers strive to produce high quality, reliable and intact data for analysis. Integral to this quality standar...

Special consideration needs to be given to providing data for interim locks and DSMBs during the course of a study. I...

A key issue in assessing the efficacy of new drugs in oncology is getting the balance right between choosing a hard e...

Oncology trials are complex and require a different approach to trials compared with many other therapeutic areas and...