Emma Dawson

After acquiring a biotech, a global pharma company faced major issues with two ongoing pharmacokinetic studies—both fully outsourced and poorly managed. Lack of CRO oversight had led to data inconsistencies, missed deadlines, and quality concerns. Phastar was brought in to take control. By providing targeted CRO oversight, identifying critical data issues, and driving process improvements, […]

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 […]

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 […]

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 […]

London, UK and Durham (NC), US – 7th March 2024. Prof Jennifer Visser-Rogers, Vice President, Statistical Research and Consultancy at Phastar, has today been announced as one of the Women in Data® Twenty in Data & Technology. The 6th series is a showcase of inspirational, trailblazing and dedicated women, encompassing every level of seniority and data […]

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

Phastar is providing pro-bono support to Medicines Development for Global Health (MDGH) as part of its Phastar CARES scheme. Phastar’s biometrics experts supported the statistical analysis plan (SAP) updates for two related studies on the treatment of onchocerciasis. Study details MDGH, a not for profit biopharmaceutical organization developing medicines for neglected diseases primarily affecting people […]

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.

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 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 […]

Season’s Greetings from the Phastar team! Each year Phastar holds an internal competition among its programmers to create a work of festive art, using only their imagination and SAS software! If you’d like to see how it all works , find the SAS code below: data xmas;%annomac;length style $200;vpos = 100;hpos = 105; green = […]

Complete the form below to watch the webinar

Complete the form below to watch the webinar

Complete the form below to watch the webinar

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 […]

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 […]

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.

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 […]

We are absolutely delighted that Phastar is now a certified B Corporation®, effective from June 2023. We are proud to be a part of this community (covering 6,800 global companies) and to reaffirm our objective to lead the CRO industry in corporate social responsibility! What does it actually mean to be a B Corp™? B […]

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 […]

Case report forms (CRFs) are critical in clinical trials as they capture vital data related to patient safety, treatment efficacy, and overall trial outcomes. Good CRF design is essential to ensure the accuracy and completion of CRFs during the data collection process, warranting the validity and reliability of trial results and leading to the approval […]

There is always an excited buzz around one or two hot topics at statistics conferences, and PSI 2023 was no exception. Previously, it’s been estimands, or real world evidence. This year we were all talking about HTA. But what is it? And why the buzz now? According to the European Commission (EC), a health technology […]

To celebrate the launch of Phastar Denmark, the company recently hosted a drinks reception for local partners and clients to come and meet the team. Situated in the Nordhavn area of Copenhagen, Phastar’s new location bolsters the company’s presence in the Nordic region and enhances its offering to local clients. Guests were warmly welcomed by […]

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 […]

Phastar’s Statistics Manager, Stephen Corson, has been chosen by the Board of Directors and the Fellows of DIA to receive the DIA 2023 Global Inspire Award for Community Engagement. This prestigious award recognises the outstanding contribution of the DIA Community Chairs who consistently drive engagement and promote knowledge sharing, while advancing thought leadership within the […]

Phastar was engaged to rescue another CROs reporting of a large phase III study in mild asthmatics to evaluate the efficacy and safety of the experimental compound. With a primary objective to prove superiority in asthma control, analyses consisted of a complex primary endpoint and a broad range of secondary endpoints which are typically observed […]

Phastar embarked on a collaboration project with Ishango.ai to work on a data science project to automate the medical coding process for adverse events using machine learning approaches. In clinical trials adverse events are coded using the MedDRA coding dictionary to standardize and allow consistent interpretation of results. There are five MedDRA classifications that each […]

Phastar recently embarked on a collaboration with Ishango.ai to host two aspiring data scientists to work on an innovative data science project. Ishango is a social enterprise that provides graduates from Africa the opportunity to gain the specialized skills required to work within the data science industry through fellowships with global companies. This was a […]

In a previous blog post, we described how, as part of the Centre for Analytical Excellence, Phastar delivered a project looking at detecting signals from historical clinical trial data and developing models to enable predictions of signals from new trials. Over a 3-month period, experts from within Phastar were provided with a large amount of […]

As part of the Centre for Analytical Excellence, we recently delivered a challenging yet enjoyable project looking at detecting signals from historical clinical trial data and developing models to enable the prediction of signals from new trials. Over a 3-month period, experts from within Phastar were provided with a large amount of historical data to […]

In recent years there has been a rising interest in the subject of mental health, and a growing understanding of the important role it plays in our everyday lives. Companies are increasingly expected to pay attention to the mental health needs of their staff, and where possible, to provide appropriate support. In the wake of […]

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. […]

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 […]

FSP (Functional Service Provision) is fairly common in the United States and Europe, where many of the world’s leading pharmaceutical and biotechnology companies are located, but the term ‘FSP’ is not yet commonplace in Japan. Furthermore, FSP is not ‘mainstream’ in China either. Japanese-based pharmaceutical companies, including foreign companies, are mainly utilising a more orthodox […]

Introduction An IDMC (sometimes known as a DMC/DMEC/DSMB) is an Independent Data Monitoring Committee, whose role it is to monitor the conduct of a clinical trial, to ensure the safety of its participants and the scientific integrity of the study. By periodically reviewing the accumulating safety, and sometimes efficacy data, the IDMC will make recommendations […]

The crucial role of clinical data management (CDM) in a successful clinical trial is well understood, and central to this is the production of quality, accurate and comprehensive clinical data. This is critical for safety and efficacy to meet the standards to pass review by the regulatory authorities. Modern techniques for CDM are emerging in […]

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 […]

Presented by: LaRee Tracy, PhD, and Joshua Baker, PhD 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 […]

Functional Service Provision (FSP) and Full- Service outsourcing models have been hotly debated topics over the past decade. Of course, both have their places in the market however market share shifts between the two have certainly been observed. As service providers continue to match their offerings with customers’ wishes, hybrid models of FSP and Full-Service […]

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 […]

Following the completion of an early phase clinical trial, the sponsor was planning a larger phase IIb study with the same compound but wanted to understand whether there were any biomarkers in the clinical data from the first study that were predictive of a specific event. Complete the form below to read the full case […]

Phastar began a relationship with a top ten pharmaceutical company carrying out statistical consultancy and were subsequently asked to bid to be a partner in a traditional outsourcing model (i.e. the reporting of clinical trials is done independently by Phastar using Phastar systems and processes). An RFI/RFP process was undertaken, and we responded, giving details […]

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 […]

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 […]

At a conference, the results of a clinical trial demonstrate that a new medicine is efficacious and safe for a particular disease or condition. Patients, understandably, want to know when they will have access to this new treatment. Regulatory approval will be sought and individual countries will need to consider reimbursement. But, before we even […]

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 […]

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) … […]

When designing a clinical trial, one of the biggest factors that needs to be thought about is blinding. In clinical trials, there is a risk of expectation influencing findings so if a patient knows which treatment group they have been allocated, there is a risk that this could bias results. In controlled trials, the term […]

Starting a career in industry can be a daunting experience at any time of life, but especially when it is your first full time job. Going from being a full-time student and enjoying the student life is very different to experiencing the 9-5 day job. From my time so far, I believe that the 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 Phastar after graduating from the University of Strathclyde with a Masters’ degree in Mathematics and Statistics. I sought a job where I would be challenged, and I was not going […]

The volume of digital data in healthcare is projected to increase more rapidly in the coming years than any other sector. On a day-to-day basis it is vital that clinical teams ensure they are maximising the value, not only of their own trial data but also of the wealth of external data for example electronic […]

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 […]

Traditionally, studies have been run with a process of study design, study conduct, study report. Whilst this is more straight-forward it is not flexible and does not allow for modifications or changes that may be desirable during the course of a trial. An adaptive design allows for the flexibility of interim reviews of the data, […]

There is considerable hype surrounding Machine learning (ML) and Artificial Intelligence (AI) yet despite that, these technologies are real and powerful and this is starting to be realised in healthcare. In this article we briefly discuss ML and AI alongside some key healthcare examples including how ML has added value in clinical trials with hands […]

In medical research, information on the outcomes of a treatment may be available from a number of clinical studies with similar treatment protocols. When the studies are considered individually, they may be either too small or too limited in scope to come to a general conclusion about the effect of the treatment. Meta-analysis, defined as […]

Integration of data from a number of clinical trials for an Integrated Summary of Safety (ISS) and Efficacy (ISE) requires careful planning and includes the following planning steps [see ICH M4]: Assess the analysis and reporting requirements for the ISS/ISE Before starting integrating data across studies it is key to have a clear understanding of […]

Phastar have attended a reception at Buckingham Palace for winners of the 2019 Queen’s Award for Enterprise. The company was awarded for excellence in the International Trade category following exponential growth from a one-person operation in 2007, to a global CRO with offices in four continents within the space of one decade. Around 300 people […]

Data quality and integrity are key aspects of Good Clinical Practice (GCP) and sponsors are expected by regulators to demonstrate oversight of clinical studies to ensure proper conduct, safety of study subjects and accuracy and completeness of the clinical study data. Risk Based Monitoring is an approach that aims to implement improved and more efficient […]

It has become easier to produce customised graphics in SAS and to produce reports that combine outputs from several different procedures. This means that refined outputs can be produced that allow more targeted monitoring of individual patients and populations of patients. Customized Graphics There is now a range of graphical elements that allow graphs in […]

Understandably, there is considerable excitement around the field of data science particularly in relation to healthcare and clinical trials. As described in another article in this newsletter “Machine Learning”, a key area of data science, is rapidly gaining traction in the healthcare industry. At Phastar, the demand for data science led services has been increasing […]

Phastar, the global CRO offering statistical consulting, clinical trial reporting and data management services to the pharmaceutical and biotech industries, is delighted to be announced as winners of the inaugural award for Innovation in the Management of Clinical Data at this years ACDM Conference. The annual awards were established in 2019 to further showcase the […]

The FDA defines an adaptive design as …an adaptive design is defined as a clinical trial design that allows for prospectively planned modifications to one or more aspects of the design based on accumulating data from subjects in the trial1. The most common adaptations of the trial design which impact on programming are: Phastar’s extensive […]

A key objective of Phase I dose escalation trials is to establish a recommended dose and/or schedule for an experimental drug or combination for further testing in Phase II. They balance avoiding unnecessary exposure of patients to subtherapeutic doses with maintaining safety and rapid enrolment. Traditional “3+3” designs and their variations are simple to implement, […]

Recently, an FDA industry guidance draft on “Multiple Endpoints in Clinical Trials”1 provided an overview of multiplicity which is a controversial topic. This is due to the practitioner’s common lack of clarity on when and how it arises and what adjustments to implement, such that the number of false positives, i.e. the type I error […]

The public consultation period for the ICH E9 (R1) addendum on estimands and sensitivity analyses to the guideline on statistical principles for confirmatory clinical trials closed at the end of February 2018, and the addendum is planned to be issued in mid-2019. At first glance the draft addendum can appear quite confusing – with a […]

A rare disease is defined by the European Union as one that affects less than 5 in 10,000 of the general population and in the US, the definition is one that affects less than 200,000 persons1. There are between 6,000 and 8,000 known rare diseases and around five new rare diseases are described in medical […]

How do you define the importance of data quality in clinical trials? An accurate reflection of a subject’s experience during a trial? Uniformity and completeness of the data collected? Frequency of deviations? All of the above. The need to define quality standards and implement structured data collection methods is imperative in order to reduce variability […]

Quality is paramount to all programming work carried out at Phastar to ensure accurate reporting and analysis of clinical trials. In order to maintain our high standards, we have SOPs and Work Instructions that detail our standardised internal processes for SAS programming and QC across studies and sites. Other resources available to staff include our […]