Author:

Hannah Gaimster

Articles by Hannah Gaimster:

Meet the Team: Melanie McGuigan, Associate Director, FSP Operations

May 8th, 2026 3 minute read

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 you tell us a […]

Phastarphastar

Effective CRO Partnerships in an Era of Clinical Trial Transformation

April 29th, 2026 1 minute read

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 […]

Technologytechnology

From Models to Meaning: Why TMLE Matters for Causal Inference 

April 29th, 2026 6 minute read

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 […]

Data programmingdata-programming

Meet the Team: Lisa Gibbons, Principal Statistician  

April 10th, 2026 4 minute read

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 you tell us a […]

Phastarphastar

Flexible Dose-Finding in Early-Phase Oncology Combination Studies Enabling Mid-Trial Dose Insertions to Improve Dose Recommendations

April 2nd, 2026 1 minute read

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 […]

Thought leadershipthought-leadership

Key Considerations for Drug Development Pipelines in Early Phase Clinical Trials

April 2nd, 2026 1 minute read

Sam Hinsley, Statistics Manager at Phastar, shares practical insights into early phase clinical trial design in a new article for Biopharm International. The piece explores the evolving statistical approaches shaping modern drug development. She examines how Phase I trials are moving beyond the traditional focus on maximum tolerated dose (MTD) toward identifying optimal biological dose […]

Thought leadershipthought-leadership

Designing Real-World Evidence for Causal Interpretation 

March 24th, 2026 4 minute read

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 […]

Data sciencedata-science

Shaping the Future of Evidence Generation  

March 23rd, 2026 5 minute read

Real-world evidence (RWE) is no longer peripheral to drug development. Across regulatory, HTA and payer environments, expectations have been shifting rapidly, driven by policy evolution, data availability, and the growing influence of AI-enabled analytics. For sponsors, the question is no longer whether to integrate RWE across drug development stages, but how early, how credibly, and how strategically.  This perspective, authored by Billy […]

Thought leadershipthought-leadership

Building a Purpose-Driven Organization: Leading in Corporate Responsibility  

March 23rd, 2026 3 minute read

As we mark B Corp Month 2026, Phastar is reaffirming its commitment to building a purpose-driven organization where people, sustainability, and community impact come first. Our approach to responsible business goes beyond compliance; it is embedded in how we support our employees, collaborate with partners, and contribute to the wider healthcare ecosystem.  Being a certified […]

Phastarphastar

Inserting Dose Levels Mid-Trial: A Smarter Approach for Early-Phase Oncology Combination Studies 

March 18th, 2026 5 minute read

Early-phase oncology trials are increasingly exploring combination therapies to improve outcomes for patients with complex cancers. While these approaches hold promise, they also introduce new methodological challenges, particularly when identifying the optimal dose combination that balances efficacy with acceptable toxicity.  In this blog, we explore how recent methodological research [1] from our statistical experts, Matt George and Ian Wadsworth, in collaboration with Pavel Mozgunov of the MRC Biostatistics Unit in Cambridge, applies […]

Biostatisticsbiostatistics

Moving From Association to Causation Using Real-World Data 

March 11th, 2026 4 minute read

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 […]

Data sciencedata-science

The EU’s Health Technology Assessment Regulation: Implementation one year on 

March 10th, 2026 1 minute read

Billy Amzal, PhD, Head of Strategic Consulting at Phastar, explores the first year of the EU Health Technology Assessment Regulation in a new article for Regulatory Affairs Professionals Society’s Regulatory Rapporteur.  He examines how Joint Clinical Assessments (JCAs) are beginning to reshape how health technologies are evaluated across Europe, the practical challenges faced by national HTA bodies and developers, and what the […]

Regulatory Affairsregulatory-affairs

Why Gender Equality Adds Up for Advancements in Statistics

March 9th, 2026 1 minute read

To mark International Women’s Day 2026, a new article in Applied Clinical Trials authored by Vicky Marriott, Head of Statistics at Phastar, explores why advancing gender equality in statistics and data science is essential for innovation, collaboration, and long-term industry growth. The article examines the barriers women continue to face across education and career progression […]

Thought leadershipthought-leadership

Meet the Team: Dan Bowgett, Senior Programmer

March 6th, 2026 3 minute read

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 you tell us a […]

Phastarphastar

The Women Behind the Work: Voices from Across Phastar 

March 5th, 2026 8 minute read

Progress in our industry is often measured in milestones, approvals, data readouts, and regulatory submissions. But behind every milestone are people.  This International Women’s Day, we’re taking a moment to spotlight some of the women across Phastar whose expertise, judgement, resilience and leadership shape our work every day. Not just in senior roles, and not just in visible moments, but across teams, disciplines, and career […]

Phastarphastar

Leading from the Front: Driving Operational Excellence and Equity in Clinical Research

March 4th, 2026 1 minute read

To mark International Women’s Day 2026, a new article in PharmaLive, authored by Sarah Tucker, Chief Operating Officer at Phastar, explores how visible, inclusive leadership and strong female representation across technical and executive teams are driving operational excellence, stronger decision-making, and improved outcomes in clinical research, while reinforcing the business case for diversity in a […]

Thought leadershipthought-leadership

How Bayesian Approaches Can Revolutionize Rare Disease Clinical Trials

March 2nd, 2026 1 minute read

Billy Amzal, Head of Strategic Consulting at Phastar, and a Bayesian design expert and pioneer, explores the techniques used in Bayesian trial designs, examines regulatory updates, and shares real-world examples of the impact of these innovative methods in a new article for Applied Clinical Trials. “With rare disease a growing area of clinical research and […]

Thought leadershipthought-leadership

How Innovative Trial Approaches are Advancing Rare Disease Research

February 27th, 2026 1 minute read

To mark Rare Disease Day 2026, a new article authored by Billy Amzal, Head of Strategic Consulting at Phastar, explores how external control arms, Bayesian borrowing, and AI-enabled digital twins can strengthen evidence generation and accelerate rare disease drug development, while meeting evolving expectations from regulators such as the FDA and MHRA. ”Innovative trial designs […]

Thought leadershipthought-leadership

How Automation and AI Are Transforming SDTM Delivery

February 19th, 2026 3 minute read

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 […]

Data sciencedata-science

Bayesian Guidance from the FDA: Then and Now.  An Interview with Billy Amzal, PhD, Head of Strategic Consulting  

February 18th, 2026 3 minute read

You were among the first to submit and defend a Bayesian trial design to the FDA around 20 years ago. How were Bayesian methods viewed by regulators at that time?     At that time, the statistical community was still quite split between frequentists and Bayesians, so it seemed additional educational work was required. In the early 2000’s, Bayesian approaches were viewed mostly as exploratory tools, essentially for early phases, in indications […]

Thought leadershipthought-leadership

The Next Generation of Trial Designs: Supplementing Trials with Real-World Data

February 10th, 2026 1 minute read

As innovative clinical trial designs gain traction, sponsors are looking more closely at how real-world data can be used to strengthen evidence generation without compromising rigor. Clearer regulatory guidance, improved data access, and advances in analytics are opening the door to more sophisticated approaches, but only when RWD is applied with intent and discipline. In […]

Thought leadershipthought-leadership

Meet the Team: Lin Jia, Associate Director Biostatistics

February 6th, 2026 2 minute read

Can you tell us a bit about your background and what led you to join Phastar?   I hold an M.S. in Statistics and have almost 15 years of experience working on clinical trials across both CRO and pharmaceutical settings. I’ve contributed to numerous studies across different therapeutic areas, gaining extensive experience in study design, analysis, and data interpretation. I […]

Phastarphastar

2026: What will Change in Preclinical and Clinical Development?

February 3rd, 2026 2 minute read

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 […]

Thought leadershipthought-leadership

Advancing Early-Phase Trials: Emerging Practices and Insights 

January 27th, 2026 6 minute read

The landscape of early-phase clinical research continues to evolve rapidly. As new therapeutic modalities emerge and regulatory expectations shift, sponsors are rethinking how dose-finding studies are designed, analyzed, and interpreted. In this blog, we explore some of the latest developments and discussion points in early-phase trials, including recommended dose ranges, backfilling, randomization, and the growing focus on patient-reported […]

Thought leadershipthought-leadership

Expert Opinion on FDA Recommendations on Bayesian Methods for Drug Development

January 27th, 2026 6 minute read

On the 12th January  2026 the FDA brought out recommended guidance on the use of Bayesian methods, this marks the first time that the FDA has brought out draft guidance on Bayesian methods outside of brief mentions within other guidelines (such as the rare disease, adaptive designs and medical devices) where it is often regulated to a short paragraph or section. They are applicable to […]

Thought leadershipthought-leadership

Understanding Key Statistical Concepts in Early-Phase Clinical Trials 

January 20th, 2026 5 minute read

Statistics sit at the heart of every early-phase clinical trial. From dose escalation to determining the Maximum Tolerated Dose (MTD), statistical decisions guide how evidence is generated, interpreted, and acted upon. These choices influence patient safety, trial efficiency, and the likelihood of identifying the right dose to take forward.  In this blog, we explore some of the key statistical […]

Biostatisticsbiostatistics

Meet the Team : Akane Sakamoto, Statistician

January 9th, 2026 4 minute read

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 […]

Phastarphastar

Trendspotting for 2026: Embracing AI, DEI Changes and Restrategizing Research Sites

January 7th, 2026 1 minute read

As artificial intelligence reshapes clinical development, sponsors are rethinking what they need from their CRO partners. Cost pressures, increasingly complex therapeutics, and the growing role of specialist biopharma are accelerating the shift away from scale-driven models toward agility, specialism, and smarter use of technology. In a new Clinical Research News trendspotting article, Graham Clark, CEO […]

Thought leadershipthought-leadership

Market and Policy Forces Shaping the Industry in 2026

January 6th, 2026 1 minute read

As pharma looks ahead to 2026, greater regulatory and geopolitical clarity is expected to unlock delayed investment decisions, but this is not without new pressures. In a new article for PharmaVoice, Graham Clark, CEO of Phastar, shares his perspectives on how stabilizing policy and trade conditions may re-energize R&D, while also reshaping the industry’s economic […]

Thought leadershipthought-leadership

Efficient Project Management for a Late-Stage Parkinson’s Disease Study 

January 6th, 2026 1 minute read

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 […]

Biostatisticsbiostatistics

Why SDTM Standards Matter for Sponsors: Laying the Foundation for Regulatory Success 

January 5th, 2026 3 minute read

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 […]

Data sciencedata-science

Exploring the Use of Patient Reported Outcomes for Primary Endpoints

December 23rd, 2025 1 minute read

As patient-centerd research continues to shape clinical trial design, electronic patient-reported outcomes (ePROs) are increasingly being considered for use as primary endpoints. In a new article for the Journal of Clinical Studies, Barbara Arch, Principal Statistician at Phastar, examines the opportunities and challenges of using ePRO data in this way, drawing on learnings from three […]

Thought leadershipthought-leadership

Designing Early-Phase Clinical Trials: Where to Begin and What to Consider 

December 16th, 2025 4 minute read

Designing an early-phase clinical trial is one of the most important, and most complex, steps in drug development. The choices made here determine how efficiently a program progresses, how robust the data will be, and ultimately, whether a promising treatment reaches patients.  In this blog, we explore where to begin when planning an early-phase study, […]

Biostatisticsbiostatistics

Statistical Considerations in Decentralized Clinical Trials

December 10th, 2025 1 minute read

Decentralized clinical trials (DCTs) continue to gain momentum as sponsors look to reduce participant burden, improve diversity, and expand access to research. But with the benefits of remote participation come new statistical and operational challenges that must be addressed early in trial planning. A new article published in Clinical Research News explores key considerations for […]

Thought leadershipthought-leadership

Hybrid DCTs Set for Surge as Innovation Outpaces Regulatory Hurdles

December 8th, 2025 2 minute read

As APAC continues to embrace digital innovation, hybrid decentralized clinical trials (DCTs) are emerging as a practical and scalable model for broadening patient access. In a new article for BioSpectrum Asia, Ping-Chung Chang, Head of Business Transformation and China General Manager at Phastar, explores how AI-enabled data processes, real-world data growth, and improved digital infrastructures […]

Thought leadershipthought-leadership

Meet the Team: Alice Wang, Associate Director of Data Science

December 5th, 2025 4 minute read

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 […]

Phastarphastar

Early Phase Clinical Trials: An Ever-Changing Landscape 

December 2nd, 2025 5 minute read

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 […]

Biotechbiotech

Turning Legacy Complexity into Submission-Ready Confidence

November 24th, 2025 1 minute read

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 […]

Biostatisticsbiostatistics

Delivering a Complex Integrated Summary of Effectiveness: Efficient Pooling and Advanced Analysis Across Four Multiple Sclerosis Spasticity Studies 

November 17th, 2025 1 minute read

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 […]

Biostatisticsbiostatistics

IDAC for a Phase III Study in Thrombotic Microangiopathy: Delivering High-Quality Statistical Support Within Budget Constraints

November 12th, 2025 1 minute read

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 […]

Biostatisticsbiostatistics

Why ‘Good Enough’ is Not Acceptable in CRO Partnerships

November 11th, 2025 1 minute read

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 […]

Thought leadershipthought-leadership

Meet the Team: Alice Spencer, Senior Statistician

November 6th, 2025 3 minute read

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 […]

Phastarphastar

Utilizing Tech Tools to Accelerate Drug Development

November 6th, 2025 1 minute read

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 […]

Technologytechnology

The Need for a DMC and the Operational Role of an Independent Data Analysis Center: Practical Insights for Sponsors 

November 4th, 2025 5 minute read

Introduction  Data Monitoring Committees (DMCs) play a pivotal role in protecting the rights, safety and well-being of trial participants and also the integrity of clinical studies. Central to their optimal effectiveness are Independent Data Analysis Centers (IDAC), which bring technical expertise, operational oversight, and strategic insight to every stage of the DMC process. By reading […]

Phastarphastar

The Rise of Innovative Trial Designs in Rare Disease Research 

October 28th, 2025 6 minute read

By Billy Amzal, Head of Strategic Consulting, Phastar  Introduction  Rare disease research demands tailored development and access strategies supported by innovative trial designs and dedicated analytics. From Bayesian designs to data augmentation approaches that strengthen probability of success, specialist CROs and experienced consultants are helping deliver smarter, faster, and more efficient drug development, ultimately bringing […]

Thought leadershipthought-leadership

Delivering a Large-Scale Integrated Summary of Safety: Standardizing 30 Studies Across Multiple Phases and Indications  

October 22nd, 2025 2 minute read

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 […]

Technologytechnology

Delivering an Integrated Summary of Safety: Resolving Data Inconsistencies and Complex Derivations to Support Regulatory Submission 

October 22nd, 2025 1 minute read

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: 

Thought leadershipthought-leadership

IDAC for Interim Analysis of a Phase III Study in Essential Tremor: Ensuring Precision Amid Shifting Priorities 

October 17th, 2025 1 minute read

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

Biostatisticsbiostatistics

Navigating DMC Meeting Requirements and Conduct: Best Practices for Sponsors

October 16th, 2025 5 minute read

Introduction A Data Monitoring Committee’s (DMC) overriding responsibility is to protect the rights, safety and well-being of trial participants. The optimal set-up and conduct of DMC meetings in clinical trials requires specialized expertise. It involves not only rigorous data review and oversight by the DMC members, but also meticulous attention to, where applicable, maintaining the […]

Phastarphastar

Optimizing DMC Management in Phase III Trials

October 14th, 2025 1 minute read

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 […]

Biostatisticsbiostatistics

Common Challenges in ISS and ISE Delivery, and How to Overcome Them 

October 13th, 2025 3 minute read

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, […]

Regulatory Affairsregulatory-affairs

Delivering Integrated Safety and Efficacy Analyses in Cushing Syndrome

October 6th, 2025 1 minute read

When faced with evolving analysis plans, minimal client infrastructure, and shifting output volumes, Phastar delivered high-quality ISS and ISE outputs for Cushing syndrome clinical studies.  By combining automation, custom macros, and strategic agility within an FSP model, our team adapted quickly to changing sponsor needs—ensuring consistent quality and on-time delivery despite significant mid-project changes.  This […]

Clinical data managementclinical-data-management

Meet the Team: Mercy Mutua, Statistician

October 2nd, 2025 4 minute read

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 […]

Phastarphastar

Phastar Scoops Multiple Finalist Positions in 2025 Scrip Awards

October 1st, 2025 3 minute read

Phastar, a global specialist biometrics & data science Contract Research Organization (CRO), has been named as finalists in two categories at the prestigious 2025 Scrip Awards. Phastar was recognized in the ‘Best Contract Research Organization – Specialist Providers’ and ‘Community Partnership of the Year’ categories at the 21st anniversary awards, which will be announced at […]

Phastarphastar

Delivering a Complex ISS in Autoimmune Pulmonary Alveolar Proteinosis

September 26th, 2025 1 minute read

Phastar supported a sponsor in delivering a high-quality Integrated Summary of Safety (ISS) for a rare disease program in aPAP, pooling three studies into multiple analysis datasets and generating 84 outputs.  Our team tackled ongoing data updates, structural variability, complex safety derivations, and FDA change requests, ensuring alignment across all outputs and regulatory readiness.  Advanced […]

Clinical data managementclinical-data-management

Delivering Integrated Efficacy and Safety Summaries in VMS

September 26th, 2025 1 minute read

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 […]

Biostatisticsbiostatistics

Preparing an Integrated Safety Summary (ISS): Why Expertise and Planning Matter 

September 22nd, 2025 3 minute read

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 […]

Thought leadershipthought-leadership

Adjusting for Time-Varying Confounding in Longitudinal Studies

September 8th, 2025 5 minute read

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 […]

Data sciencedata-science

Meet the Team: Jagdish Nikam, Statistician

September 3rd, 2025 5 minute read

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 you […]

Phastarphastar

Specialist Data-Focused CROs: The Partnership Solution for Modern Clinical Trials

August 27th, 2025 1 minute read

Outsourcing clinical trial activities to specialist data-focused CROs is growing rapidly, driven by the need for expert data management, biostatistics, and faster time to market. These partnerships deliver cleaner, more reliable data, streamlined operations, and faster regulatory acceptance. In an article for International Clinical Trials, Stephen Corson, Associate Director, Statistics & Technical Solutions at Phastar […]

Thought leadershipthought-leadership

A Conversation with Billy Amzal: Phastar’s new Head of Strategic Consulting

August 21st, 2025 1 minute read

In this exclusive interview for World Pharma Today, Phastar’s Head of Strategic Consulting, Billy Amzal, shares his career insights, regulatory perspectives, and how data-driven strategies are accelerating smarter, safer, and more impactful healthcare decisions. ”We are increasingly seeing regulatory agencies specify the context of use for novel approach methodologies such as Bayesian statistics. I believe […]

Thought leadershipthought-leadership

Stepping Into Leadership: What is Needed for New Managers to Excel

August 20th, 2025 1 minute read

In ACRP Clinical Researcher, Katie Dixon, Senior Statistician at Phastar, reflects on the transition from graduate to manager and the support required for new leaders to thrive. “As outlined in my own experience, shadow-lead roles are one way organizations can support staff as they prepare to transition into management roles. Another effective intervention is the […]

Thought leadershipthought-leadership

Meet the Team: Sam Hinsley, Statistics Manager 

August 7th, 2025 6 minute read

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 […]

Phastarphastar

Practical Tips for CDM and Biostatistics Alignment

August 6th, 2025 4 minute read

Smooth collaboration and effective integration between clinical data management (CDM) and biostatistics does not happen by chance. Without strong integration, clinical trials often suffer from delays during data handoffs, inconsistent data standards, increased rework, and compromised data quality. These challenges slow database lock, complicate analysis, and jeopardize submission readiness, putting your trial timelines and regulatory […]

Clinical data managementclinical-data-management

Meet Billy Amzal: Smarter Clinical Trial Design for Today and Tomorrow 

July 31st, 2025 4 minute read

Phastar recently welcomed Billy Amzal as Head of Strategic Consulting. A statistician, public health scientist, and entrepreneur, Billy brings more than 25 years of experience across the biotech and pharmaceutical industries, health agencies, and consulting.  His expertise lies in innovative, regulatory-grade statistical methodologies including adaptive trial designs, model-based meta-analysis, Bayesian approaches, and predictive modeling using […]

Thought leadershipthought-leadership

Bridging the Gap: Building Synergy Between Clinical Data Management and Biostatistics 

July 21st, 2025 4 minute read

When Clinical Data Management (CDM) and biostatistics teams collaborate from the outset of a trial, the impact is transformative. Clearer endpoint definitions, more consistent data capture, and faster, cleaner analysis pipelines all become achievable. This helps result in accelerated timelines, fewer surprises during database lock, and a higher level of confidence in your regulatory submissions.  […]

Clinical data managementclinical-data-management

Leading with Vision: Graham Clark on the Future of Clinical Research and AI

July 16th, 2025 1 minute read

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, […]

Thought leadershipthought-leadership

What Today’s Trials Need: Specialist CROs vs Full-Service CROs 

July 8th, 2025 4 minute read

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 […]

Thought leadershipthought-leadership

Meet the Team: Tricia Peng, Senior Manager in Talent Acquisition 

July 3rd, 2025 4 minute read

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 […]

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Delivering Scalable FSP Solutions for a Top 20 Global Pharmaceutical Company 

June 26th, 2025 1 minute read

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 […]

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Phastar Appoints Industry Veteran Billy Amzal as Head of Strategic Consulting

June 24th, 2025 2 minute read

London, UK, and Durham (NC), US – June 24th, 2025: Phastar, a global specialist biometrics & data science Contract Research Organization (CRO), today announced the appointment of Billy Amzal as Head of Strategic Consulting. Amzal is a statistician, public health scientist, and entrepreneur with more than 25 years of experience across biotech and pharmaceutical industries, […]

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Bayesian vs. Frequentist Approaches in Rare Disease Trials 

June 17th, 2025 5 minute read

Introduction  Randomized Controlled Trials (RCTs) remain the cornerstone of evidence generation in clinical research, providing rigorous and unbiased assessments of treatment efficacy and safety. The frequentist framework, which underpins most traditional trial designs, relies on predefined sample sizes and statistical significance thresholds. While effective for common conditions with large patient populations, these methods often face […]

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Using Real-World Data to Predict Diabetic Complications in PRECARD study 

June 11th, 2025 1 minute read

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

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Specialist CROs: The Strategic Partnership Needed for Biotechs

June 10th, 2025 1 minute read

In a recent Q&A with European Biopharmaceutical Review, Stephen Corson—Associate Director of Statistics and Technical Solutions and Head of Statistical Consultancy at Phastar—shared expert insights on the strategic decisions that biotechs must make to ensure successful drug development. A key focus of the discussion was the importance of selecting the right biotech solutions provider and […]

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Meet the Team: Maisie Carscadden, Events Marketing Manager 

June 5th, 2025 5 minute read

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 […]

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Accelerating Clinical Data Review: Addressing Fragmentation, Improving Collaboration, and Reducing Review Cycle Times by 35% 

June 4th, 2025 1 minute read

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 […]

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Use of Expert Prior Elicitation for Clinical Research

May 29th, 2025 2 minute read

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 […]

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Flexibility and Precision: How Phastar is Driving Innovation in Clinical Trials

May 20th, 2025 1 minute read

In this exclusive Discover Pharma interview, Sarah Tucker, Chief Operating Officer at Phastar, shares how the CRO is transforming clinical trials through flexible, data-driven delivery and patient-centric innovation. From decentralized models to Lean Six Sigma, she offers key insights into balancing speed with scientific rigor in today’s evolving trial landscape. ”As specialists in biometrics and […]

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Health Technology Assessment – Challenges and Opportunities for Developers

May 20th, 2025 1 minute read

With major changes ahead for EU Health Technology Assessments (HTAs), including the introduction of joint clinical assessments from 2025, developers must adapt quickly to new regulatory expectations. In a recent article for PharmaPhorum, Stephen Corson, Associate Director, Statistics and Technical Solutions and Head of Statistical Consultancy at Phastar, outlines how developers can prepare for the […]

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Transforming Clinical Trials with Real-World Evidence 

May 19th, 2025 4 minute read

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 […]

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Phastar Shortlisted for Excellence in Clinical Trial Management at the Fierce CRO Awards 2025

May 15th, 2025 2 minute read

Phastar has been shortlisted for the Excellence in Clinical Trial Management category at the Fierce CRO Awards 2025. The award recognizes organizations that are redefining trial delivery through innovation, efficiency, and improved oversight. Our entry highlighted the impact of Phastar’s Clinical Intelligence platform, developed to support real-time oversight across complex trials by integrating operational, statistical, […]

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Accelerating Clinical Trials Through Data Science Solutions, Advanced Analytics and Visualization

May 13th, 2025 1 minute read

In an exclusive feature for Contract Pharma, Phastar’s Head of Business Transformation and China General Manager, Ping-Chung Chang, examines how data sciences solutions including advanced analytics and data visualization are accelerating clinical development. He discusses the increasing complexity of clinical trials and how integrating real-time insights and AI-driven tools is transforming operations, enhancing recruitment, and […]

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Confounding in Real-World Data: Challenges and Solutions 

May 9th, 2025 5 minute read

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 […]

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Meet the Team: Louise Hazeldine, Senior Programmer 

May 8th, 2025 4 minute read

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 […]

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How to Use the Power of Network Meta-Analysis (NMA) in Clinical Research 

May 2nd, 2025 4 minute read

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, […]

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Reducing the Environmental Impact of Healthcare Data Science: A Step Towards Sustainability 

April 28th, 2025 4 minute read

At Phastar, we are passionate about accelerating the pace of clinical development through specialist biometrics and data science solutions, supporting our clients in their mission to improve human health. But as we work with our clients to develop better treatments, it is important to reflect on the impact our industry has on the planet. From […]

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Building Effective Partnerships Between Biotechs and CROS to Optimize Outsouring

April 22nd, 2025 1 minute read

With biotechs increasingly driving innovation in research and development, it is important for organizations to choose the right outsourcing partner to overcome challenges around data, infrastructure and expertise. But how can biotechs do this best? Stephen Corson’s, Associate Director of Statistics and Technical Solutions and Head of Statistical Consultancy at Phastar, article with Journal for […]

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Expert Insights on Enhancing Efficiency in Early Phase Combination Trials 

April 14th, 2025 4 minute read

Early-phase clinical trials play a critical role in drug development, particularly in determining the right dose and combination of treatments for later-stage testing. With the increasing complexity of combination therapies, traditional trial designs often struggle to keep pace.  In our recent webinar, Dr. Pavel Mozgunov (MRC Investigator, MRC Biostatistics Unit, University of Cambridge), Weishi Chen […]

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Phastar Secures Finalist Spot at 2025 Citeline Awards 

April 10th, 2025 3 minute read

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 […]

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Pharma’s Future: Graham Clark on Trends and Challenges

March 31st, 2025 1 minute read

In an interview with The Clinical Trial Vanguard, Phastar CEO Graham Clark explores the evolving pharmaceutical landscape. He shares insights on the latest industry trends, highlighting the growing role of technology in clinical trials and the strategic advancements shaping drug development and trial management.

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Phastar Achieves B Rating in CDP, Strengthening Our Leadership in Corporate Responsibility 

March 24th, 2025 2 minute read

As we celebrate B Corp Month, Phastar reaffirms its commitment to responsible business practices that drive real impact. We continue to drive sustainability through initiatives such as our net-zero targets, pro bono biometrics support for charities, and ESG-driven clinical trial solutions.  Additionally, we are proud to announce that Phastar has improved its CDP sustainability score, […]

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Navigating the Real-World: How to Better Utilize Real-World Evidence

March 17th, 2025 1 minute read

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).

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It’s Time for the Life Science Industry to Accelerate Action for Gender Equality

March 11th, 2025 2 minute read

As we mark International Women’s Day 2025, Phastar is calling for accelerated action toward gender equality in data and STEM fields. At the current pace, full gender parity won’t be reached until 2158, making it crucial for our industry to act now. While Phastar is proud that over 56% of our data experts are women, […]

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Using Bayesian Statistics to Support Rare Disease Research Innovations

February 28th, 2025 1 minute read

On Rare Disease Day, we highlight the potential of Bayesian statistics to overcome recruitment challenges in rare disease trials. In an article for ACRP Clinical Researcher, Giles Partington, Principal Statistician at Phastar, explores how incorporating prior data and expert judgment can reduce sample size requirements, improve efficiency, and increase trial success rates. ”There are between […]

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Phastar CEO Graham Clark on AI-Driven Analytics and Data Management in Clinical Trials – SCOPE 2025 Interview 

February 24th, 2025 2 minute read

At SCOPE 2025, Phastar CEO Graham Clark spoke with Applied Clinical Trials (ACT) about the future of clinical trial optimization. Discussing Phastar’s Best in Show-winning Clinical Intelligence Portal, he highlighted how data science solutions such as AI-driven analytics and real-time insights are transforming trial oversight.  ” The first thing, the bedrock of everything, is rigorous data […]

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Phastar Secures SCOPE US ‘Best in Show’ Accolade for Clinical Intelligence Platform

February 13th, 2025 3 minute read

London, UK, and Durham (NC), US – February 13th, 2025: Phastar, a global specialist biometrics & data science contract research organization (CRO), won a Best of Show Award at Summit for Clinical Ops Executives (SCOPE) US 2025. Having taken place in Orlando, Florida from the 3rd-6th February, SCOPE’s 300+ attendees voted on more than 60 product […]

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How to Implement a Gold Standard FSP Solution

January 22nd, 2025 1 minute read

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 […]

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 The Industry’s AI Future

January 15th, 2025 1 minute read

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 […]

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Trendspotting: Predictions for Clinical Research in 2025

January 8th, 2025 1 minute read

Graham Clark, CEO at Phastar, contributed to Clinical Research News on his predictions for clinical research in 2025. Clark highlighted the growing efficiency brought by AI but warned of a critical talent shortage in specialized roles like AI experts and data scientists. He urged the industry to upskill and adapt to new technologies to avoid […]

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Phastar’s Apprenticeships: Sarah’s Story 

December 2nd, 2024 7 minute read

Having completed an undergraduate degree in mathematics, Sarah Crossley joined the Phastar apprenticeship scheme in January 2024, where they are currently pursuing a master’s degree while working as a statistician. This apprenticeship scheme is distinct from the Phastar graduate program, which is designed for individuals who have recently graduated from an MSc or PhD. In […]

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Choosing the Right Strategic Partner to Optimize Clinical Trial Outsourcing with an FSP Solution

November 11th, 2024 1 minute read

Elisa Mansfield, Vice President FSP at Phastar contributed an article to European Pharmaceutical Contractor discussing the rise of a FSP solution to outsourcing, the advantages to this method and how to select the right strategic partner to optimize outsourcing for the greatest efficiency, quality and flexibility. ‘Outsourcing allows sponsors to reduce costs, gain specific domain […]

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Empowering Women in STEM with Empathy

October 31st, 2024 1 minute read

Vicky Marriott, Head of Statistics at Phastar recently spoke with Outsourcing Pharma for its Women in Science feature. In the exclusive interview she discusses her career to date, the challenges she has faced and how she wants to inspire the next generation of women in statistics. ‘I also had a preconception that you needed to […]

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Phastar Achieves Bronze EcoVadis Rating, Reflecting Our Continued Leadership in Corporate Responsibility. 

October 24th, 2024 3 minute read

We are proud to announce that Phastar has improved its EcoVadis sustainability score, achieving a commendable 60 this year. This progress places us within the top 35% of companies, earning a prestigious bronze rating.   EcoVadis is a trusted global provider of business sustainability ratings, helping organizations measure and improve their impact on society and the […]

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Key Insights on Conducting Clinical Trials with Decentralized Elements: Summarizing the FDA Guidance 

October 22nd, 2024 11 minute read

By Lucy Clark, Statistics Manager, and Barbara Arch, Senior Statistician.  The United States Food and Drug Administration (FDA) recently (September 2024) published a finalized guidance document on Conducting Clinical Trials with Decentralized Elements. [1] This document is aimed at sponsors, investigators, and other interested parties. Two of our expert statisticians at Phastar have summarized the […]

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Implementing a Gold Standard FSP Solution

October 17th, 2024 1 minute read

Elisa Mansfield, Vice President, FSP at Phastar, contributed an article for the October issue of Applied Clinical Trials titled ‘Implementing a Gold Standard FSP Strategic Partnership’. The article discusses how biotech and biopharma companies can make sure they choose the right FSP solution to maximize financial efficiency, quality, operational effectiveness, and overall success. ‘In a […]

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Leveraging Data for Improved Employee Mental Health 

October 10th, 2024 2 minute read

On this World Mental Health Day, Phastar stands in support of raising awareness and fostering open conversations about mental well-being. This year’s theme, “Time to Prioritize Mental Health in the Workplace,” underscores the critical importance of addressing mental health and well-being for the benefit of individuals, organizations, and communities.  At Phastar, we are dedicated to […]

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How to Fully Exploit Data Visualization in Clinical Trials to Ensure all Valuable Insights are unlocked

August 12th, 2024 1 minute read

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 […]

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Interview: Phastar’s Graham Clark on how AI and Data Science Solutions are Shaping the Pharma Landscape

July 29th, 2024 1 minute read

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 […]