In clinical research and real-world evidence generation, one of the most common scientific questions we face is deceptively simple: what would happen to outcomes if all patients received treatment A instead of treatment B?  While the question sounds straightforward, the statistical reality behind it is far more complex. At its core, this is a population-level causal […]

Introduction  As regulatory demands intensify, the challenge for sponsors is not just to produce SDTM-compliant data, it must be done rapidly, accurately, and at scale. Traditional SDTM programming can be resource-intensive, especially when managing frequent updates or pooled submissions.  At Phastar, our MAPIT automation tool redefines how SDTM packages are created, combining metadata-driven processes, artificial […]

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 | […]

Introduction  In today’s data-driven clinical research environment, regulatory authorities expect structured, traceable, and high-quality data submissions. The Study Data Tabulation Model (SDTM) has become the global standard for achieving this. Since 2016, submission of clinical data in SDTM format has been mandatory for most regulatory authorities, including the FDA, PMDA, and NMPA.  For sponsors, this […]

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 […]

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: 

Introduction  Integrated Summaries of Safety (ISS) and Effectiveness (ISE) bring together data from across clinical trials to give regulators a clear picture of a treatment’s risk and benefit profile. While the Common Technical Document (CTD) format provides clinical summaries of efficacy and safety (SCE and SCS), US regulations still require detailed ISE and ISS documents, […]

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 […]

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 […]

Introduction  In clinical research, selecting the most effective treatment can be challenging, especially when multiple options exist but direct head-to-head comparisons are limited. Network Meta-Analysis (NMA) is a powerful statistical technique that helps overcome this challenge by integrating both direct and indirect evidence to compare multiple treatments simultaneously.  This blog will introduce what NMA is, […]

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 […]

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 […]

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 […]

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 […]

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 = […]

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 […]

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 […]

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

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 […]

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 […]

Phastar has a number of sponsor relationships where we provide teams of statisticians and statistical programmers to complement the internal teams within medium and large pharma companies. For example, we provide a large integrated production team of statisticians and statistical programmers to a large global pharmaceutical company. The Phastar staff primarily work from our offices […]

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 […]

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 […]

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 […]

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 […]

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 […]

Oncology trials are complex and require a different approach to trials compared with many other therapeutic areas and can generate significant programming challenges. Oncology can be associated with fast developing disease and short survival times. Due to the fact that many oncology trials are event-driven, the timelines and resources are regularly reviewed and updated. In […]