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 […]

Clinical trials are inherently complex, with risks emerging across data quality, patient safety, site performance, and operational execution. Identifying and addressing these risks early is critical to maintaining timelines and ensuring successful outcomes. Real-time dashboards are transforming how organizations approach risk mitigation by providing continuous visibility and actionable insights throughout the trial lifecycle.  Moving from reactive to proactive  Traditional risk management approaches […]

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 […]

Causal inference begins with clarity about the research question. What population, treatment, comparator, and outcome are you evaluating? Defining these elements upfront allows you to plan how real-world data can emulate the conditions of an ideal randomized trial, rather than trying to fit your question to the data you have. This blog challenges the idea that real-world data […]

Real-world data (RWD) can provide insight into benefits, risks and usage of medical products. Unlike controlled randomized trials, RWD can capture patient populations and situations that may not be feasible to address in a clinical trial. This makes RWD a useful source for better understanding patients. However, when the goal is to understand how a medical product performs association can be misleading. Discovering that a drug is associated with improved outcomes, does […]

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:

As innovation reshapes drug development, industry leaders are looking ahead to how both preclinical discovery and clinical trials will evolve in 2026, and the role regulators will play in shaping that future. Advances in structural biology, hybrid study designs, and the expanding use of real-world evidence are expected to influence decision-making earlier and more meaningfully […]

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 […]

As clinical trials grow increasingly complex, sponsors are turning to specialist CROs with the expertise to transform data into regulatory-grade evidence. In this article for The Medicine Maker, Stephen Corson, Associate Director of Statistics & Technical Solutions at Phastar, discusses how the CRO model is evolving, from transactional service delivery to strategic partnership, helping sponsors […]

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 […]

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 Real-world data (RWD) can provide insight into treatment effects in a real-world setting. However, because treatment allocation in RWD is not random, analyses are susceptible to confounding, when a variable influences both treatment and outcome, potentially biasing results. When the exposure of interest varies over time, there may be time-varying confounding. Key confounders can […]

In an exclusive interview with the European Medical Journal, Graham Clark, CEO of Phastar, discusses the current state of clinical research, the future role of AI in the industry, and how to build a values-driven company. ” The biggest challenge we face is balancing the need for speed and innovation with the imperative for quality, […]

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 […]

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

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  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 […]

Introduction  Real-world data (RWD) plays a crucial role in medical research, providing valuable insights from a  variety of sources including electronic health records and claims databases. However, unlike randomized controlled trials, allocation is not random. This can result in confounding.   Understanding and addressing confounding is essential for valid causal inference. This blog post explores challenges […]

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

In our “Meet the Team” series, we highlight the talented individuals who drive Phastar’s success. Each team member brings unique skills, experience, and passion to their role, working together to deliver high-quality biometrics and data science solutions in clinical research. Below, we share their career journey, insights, and the impact they make every day. Can […]

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 […]

Matthew Thompson, Associate Director, Statistical Programming at Phastar, authored a piece for Clinical Research News on how Real-World Evidence (RWE) is transforming drug development. He explores the benefits of RWE in hybrid trials, patient recruitment, and adaptive designs, as well as the challenges of working with Real-World Data (RWD).

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 […]

Elisa Mansfield, Vice President of FSP at Phastar, contributed an article to Pharmaceutical Outsourcing discussing the critical role of selecting the right FSP solution for biotech and biopharma organizations. She explored how these strategic partnerships can optimize quality, financial efficiency, and operational effectiveness. “By building good-standard partnerships, biotech, and biopharma companies can ensure they maximize […]

Real-World Evidence (RWE) is redefining how healthcare and drug development insights are generated. This blog explores the advantages utilizing RWE can offer, the factors driving its growing significance, and the benefits that utilizing it brings to regulators, patients, and pharma companies.  What Is RWE?  RWE is derived from analyzing Real-World Data (RWD)—information gathered from sources […]

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 […]

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 […]

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 […]

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 […]

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 […]

Originally published in Business Wire. Boston, MA US – 20th May 2024: Beaconcure Inc., a leader in AI-enabled clinical data validation and automation, announces a strategic partnership with Phastar Inc., a global specialist biometrics contract research organization (CRO), to enhance clinical review processes in clinical trials. This partnership combines Beaconcure’s advanced technology with Phastar’s extensive experience and vision […]

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, 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 […]

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 […]

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. […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 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 […]

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 […]