Blogs 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-...
Blogs 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 clini...
Blogs 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 te...
Blogs 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 Saf...
Blogs 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, becau...
Blogs 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 te...
Blogs 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 te...
Blogs 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 happ...
Blogs 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 e...
Blogs 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 tra...
Blogs 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...
Blogs 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 te...
Blogs 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,...
Blogs 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 te...
Blogs Can Patient Reported Outcomes be used for Primary Endpoints? May 22nd, 2025 11 minute read Introduction Patient reported outcomes (PRO) have been used in clinical trials for many years, but it is only r...
Blogs 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 Phast...
Blogs 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. ...
Blogs 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...
Blogs 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 te...
Blogs 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 m...
Blogs 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 d...
Blogs 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 ...
Blogs Meet the Team: Rodgers Ngetich, Clinical Data Coordinator April 11th, 2025 5 minute read In our “Meet the Team” series, we highlight the talented individuals who drive Phastar’s success. Each te...
Blogs How to Enable Multi-Directional Data Flow in Clinical Trial Data Portals April 9th, 2025 3 minute read In the evolving landscape of clinical trials, data monitoring has traditionally been a one-way street, data flows fro...
Blogs 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 impa...
Blogs Webinar Report on Expert Prior Elicitation in Clinical Trials March 20th, 2025 4 minute read Introduction Our webinar explored the use of expert prior elicitation techniques in clinical research, pa...
Blogs Vendor Selection in Biotech Partnerships: Key Factors for Success February 27th, 2025 4 minute read Introduction For biotechs looking to advance clinical development, selecting the right CRO partner can be a def...
Blogs Webinar Report: Mastering Clinical Trial Outsourcing: FSP Strategies from Industry Experts February 4th, 2025 5 minute read During our recent webinar, we brought together key industry leaders to discuss the evolution and strategic value of F...
Blogs Overcoming Challenges in Using Real-World Evidence in Clinical Trials January 29th, 2025 5 minute read Introduction Integrating Real-World Data (RWD) and Real-World Evidence (RWE) into clinical research is gaining signif...
Blogs The Value of Strategic Collaboration: Overcoming Key Challenges in Biotech Development Through Effective Outsourcing January 23rd, 2025 4 minute read Introduction In today’s fast-evolving environment, biotechs need to form strategic partnerships to address reso...
Blogs The Benefits of Using Real-World Evidence in Clinical Research January 21st, 2025 5 minute read Real-World Evidence (RWE) is redefining how healthcare and drug development insights are generated. This blog explore...
Blogs Understanding the Growth of Biotech in Clinical R&D and Its Need for Strategic CRO Partnerships January 16th, 2025 4 minute read Introduction The biotech industry has become a driving force in clinical research, accelerating advances in are...
Blogs Understanding the Challenges of the New HTA in Europe December 18th, 2024 5 minute read The implementation of the New Health Technology Assessment (HTA) framework in Europe is a pivotal moment for the regi...
Blogs Webinar Report: Unlocking the Power of Real-World Data (RWD) in Clinical Trials December 11th, 2024 5 minute read Real-world data (RWD) and real-world evidence (RWE) are transforming the clinical research landscape. During our rece...
Blogs Establishing an Optimal FSP Solution to Accelerate Drug Development December 3rd, 2024 4 minute read Introduction Phastar’s recent webinar, “Implementing a Gold Standard FSP Strategic Partnership to Fuel Ef...
Blogs 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 J...
Blogs Breaking Down Borders: How EU HTA Is Harmonizing Health Technology Assessments November 27th, 2024 5 minute read Introduction The EU Health Technology Assessment (HTA) is set to undergo significant transformation at the begi...
Blogs EU Net HTA: The Blueprint for a Unified European Health Assessment November 12th, 2024 4 minute read Introduction Health Technology Assessments (HTA) are a vital process within healthcare systems, evaluating the value ...
Blogs What Are the Challenges of Implementing RBQM? October 28th, 2024 4 minute read Introduction Risk-Based Quality Management (RBQM) has emerged as a powerful tool for optimizing clinical trial ...
Blogs Webinar Report: Health Technology Assessments (HTA) – Challenges and Opportunities October 28th, 2024 5 minute read Our recent webinar explored the complexities of Health Technology Assessments (HTA), their current role in evaluating...
Blogs 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...
Blogs 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 Admin...
Blogs Why Risk-Based Quality Management (RBQM) Is the Future of Clinical Trial Oversight October 14th, 2024 6 minute read Introduction Risk-Based Quality Management (RBQM) is revolutionizing the way clinical trials are managed, offer...
Blogs 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 abou...
Blogs The State of the CRO Industry: What Matters Most When Choosing a Partner? October 3rd, 2024 5 minute read In the dynamic world of clinical research, selecting the right Contract Research Organization (CRO) partner is more i...
Blogs The Key Role of Data Visualization in Modernizing Clinical Trials October 1st, 2024 4 minute read In the rapidly advancing world of clinical trials, data visualization plays a transformative role by enhancing effici...
Blogs Benefits and Risks of the BOIN12 Design for Early Phase Oncology Trials under the Paradigm of Project Optimus October 1st, 2024 9 minute read Since the introduction of Project Optimus by the FDA in 2020 [1], it has become more important than ever to ensure th...
Blogs Phastar Network Meta-Analysis Poster Presentation for ICTMC 2024 October 1st, 2024 5 minute read Psoriasis is an inflammatory disease characterised by lesions on the skin and has a prevalence of around 2% in the gl...
Blogs The Future of Clinical Trials: Which Innovations Will Lead the Way? September 19th, 2024 4 minute read The landscape of clinical trials is undergoing a significant transformation, driven by rapid advancements in technolo...
Blogs Top Challenges in Clinical Trial Management: Industry Insights September 12th, 2024 4 minute read Managing clinical trials is no easy task, with a range of challenges that can impact the success of a study. To gain ...
Blogs What are the Challenges Surrounding Implementation of Project Optimus? September 10th, 2024 5 minute read Introduction Project Optimus marks a major advancement in optimizing patient outcomes in oncology. By prioritizing do...
Blogs Project Optimus: Three Key Benefits for Patients, Researchers, and Clinicians August 27th, 2024 5 minute read Introduction With the launch of Project Optimus, the FDA is overhauling the paradigm of dose optimization and selecti...
Blogs What Does Project Optimus Mean for Your Clinical Trials? August 13th, 2024 6 minute read Introduction The Project Optimus initiative is a key part of the U.S. Food and Drug Administration (FDA’s) Onco...
Blogs Contemporary Clinical Trials: Navigating Innovations in Trial Methodologies July 24th, 2024 11 minute read By Michael Willis, MSc, Senior Statistician, and Lisa Gibbons, MSc, Senior Statistician Introduction The landscape of...
Blogs Navigating Project Optimus: Implications and Strategies for Oncology Drug Development July 17th, 2024 5 minute read Introduction With the launch of Project Optimus, the FDA aims to reform the dose optimization and dose selection para...
Blogs Key Insights on Data Monitoring Committees: Summarizing the FDA Guidance July 15th, 2024 11 minute read By Wei Liu, PhD, Associate Director, Biostatistics, and Gillian Armstrong, MSc, Consultant Statistician The FDA recen...
Blogs Master Protocols for Drug and Biological Product Development June 24th, 2024 7 minute read By Tina Hovey, Principal Statistician, and Gillian Armstrong, Consultant Statistician, Phastar The FDA recently publi...
Blogs Elevating medical monitoring: Harnessing the power of guided analytics with Phastar’s Clinical Intelligence Platform June 20th, 2024 6 minute read Medical monitoring is one of the most important aspects of any clinical trial, but traditional approaches are time-co...
Blogs Faster than you can say “Tipping Point Analysis” June 17th, 2024 7 minute read Introduction An abundant problem in clinical trials is the absence of data due to patients prematurely withdrawing fr...
Blogs Reviewing and Updating the Statistical Analysis Plan and Creating Mock Shells as Part of the Phastar CARES Scheme February 19th, 2024 4 minute read Phastar is providing pro-bono support to Medicines Development for Global Health (MDGH) as part of its Phastar CARES ...
Blogs Season’s Greetings from Phastar’s 2023 SAS Art Competition Winner! December 14th, 2023 3 minute read Season’s Greetings from the Phastar team! Each year Phastar holds an internal competition among its programmers...
Blogs Bayesian Statistics: Why we Shouldn’t Ignore this Important Statistical Paradigm November 23rd, 2023 5 minute read Authors: Giles Partington, Sarah Simpson, Lauren Rojas, Emily Foreman, Ian Wadsworth. Bayesian statistics is one of t...
Blogs Frequentist vs Bayesian Approaches to Clinical Trials: A Targeted Systematic Review November 23rd, 2023 4 minute read The European Medical Association (EMA) defines “rare diseases” as diseases that affect fewer than 5 in 10,000 people;...
Blogs Phastar Celebrates Third Annual Sally Hollis Memorial Lecture November 2nd, 2023 5 minute read A great turnout of members from the Phastar family, together with guests from the wider community, gathered in Maccle...
Blogs Phastar is Now a B Corp™ – What, How, and Why? July 11th, 2023 5 minute read We are absolutely delighted that Phastar is now a certified B Corporation®, effective from June 2023. We are proud to...
Blogs AutoCRF: A Tool to Create a Mock eCRF Screen from Excel Data Specifications June 21st, 2023 4 minute read Case report forms (CRFs) are critical in clinical trials as they capture vital data related to patient safety, treatm...
Blogs Decoding the HTA Craze: A Closer Look at the Exciting World of Health Technology Assessment (HTA) at PSI 2023 June 10th, 2023 3 minute read There is always an excited buzz around one or two hot topics at statistics conferences, and PSI 2023 was no exception...
Blogs Addressing Data Sparsity in Clinical Trials — and Female Sparsity in Data Science May 11th, 2023 5 minute read Digital Health Technologies (DHTs) are democratizing data collection during clinical trials, while promising to make ...
Blogs Data Science Collaboration with Ishango.ai – Part Two December 14th, 2022 4 minute read Phastar embarked on a collaboration project with Ishango.ai to work on a data science project to automate the medical...
Blogs Data Science Collaboration with Ishango.ai – Part One November 25th, 2022 3 minute read Phastar recently embarked on a collaboration with Ishango.ai to host two aspiring data scientists to work on an innov...
Blogs Smart Signal Detection — Part Two November 10th, 2022 3 minute read In a previous blog post, we described how, as part of the Centre for Analytical Excellence, Phastar delivered a proje...
Blogs Smart Signal Detection — Part One November 2nd, 2022 5 minute read As part of the Centre for Analytical Excellence, we recently delivered a challenging yet enjoyable project looking at...
Blogs Phastar’s Approach to Digital Health August 25th, 2022 6 minute read Currently, there is no widely adopted definition of Digital Health. At Phastar, we take a broad view and refer to Dig...
Blogs The COVID Impact on Clinical Trials Requires New Approaches for Statisticians March 10th, 2022 10 minute read COVID-19 and its subsequent variants have provided challenges in many ways, not the least of which are in the conduct...
Blogs Missing Data Caused by the COVID-19 Pandemic on Clinical Trials – Overall Approach December 13th, 2021 5 minute read In our final blog of the series, we examine the impact of missing data caused by the COVID-19 pandemic on clinical tr...
Blogs The Effect of COVID-19 on the Estimands of Clinical Trials December 8th, 2021 4 minute read In our latest blog of the series, we examine the topic of estimands with respect to clinical trials affected by the C...
Blogs Assessing The Impact of COVID-19 on a Clinical Trial December 6th, 2021 5 minute read In this blog series, we examine the impact of COVID-19 on the conduct, analysis, and interpretation of ongoing clinic...
Blogs How the COVID-19 Pandemic has Affected Clinical Trials December 3rd, 2021 4 minute read Throughout this blog series, we will be discussing how the COVID-19 pandemic situation has affected clinical trials, ...
Blogs Delivering an Interim Analysis During a Pandemic from a Data Management Perspective May 12th, 2021 6 minute read When the World Health Organisation (WHO) declared the COVID-19 pandemic on 11th March 2020, countries the world over ...
Blogs How FSP Can Increase Efficiency and Quality in Japan May 12th, 2021 4 minute read FSP (Functional Service Provision) is fairly common in the United States and Europe, where many of the world’s ...
Blogs A Programmer’s View on IDMCs May 12th, 2021 5 minute read Introduction An IDMC (sometimes known as a DMC/DMEC/DSMB) is an Independent Data Monitoring Committee, whose role it ...
Blogs The Application of AI in the Management of Data January 25th, 2021 3 minute read The crucial role of clinical data management (CDM) in a successful clinical trial is well understood, and central to ...
Blogs The Pros and Cons of FSP and Full-service August 18th, 2020 10 minute read Functional Service Provision (FSP) and Full- Service outsourcing models have been hotly debated topics over the past ...
Blogs Method Agreement Analysis – Common Pitfalls and a Review of Methodology February 25th, 2020 6 minute read A common question in clinical research is whether a new method of measurement is equivalent to an established one. As...
Blogs Technology, AI and Real World Evidence February 25th, 2020 3 minute read Real world evidence (RWE) in medicine is the clinical evidence regarding the use and potential benefits or risks of a...
Blogs How can we Compare Medicines from Different Clinical Trials? February 24th, 2020 3 minute read At a conference, the results of a clinical trial demonstrate that a new medicine is efficacious and safe for a partic...
Blogs From Practical Maths to Superstar Stats – Zoe’s Story February 14th, 2020 5 minute read I started out my university experience by going to Dundee to study mathematics, this was mainly a theoretical degree ...
Blogs A Quantitative Framework to Inform Extrapolation Decisions in Children February 13th, 2020 6 minute read When developing a new medicine for children, the potential to extrapolate from adult efficacy data is well recognised...
Blogs What About the Smell? – Challenges of Clinical Trial Design and Maintaining Blinding January 15th, 2020 5 minute read When designing a clinical trial, one of the biggest factors that needs to be thought about is blinding. In clinical t...
Blogs Phastar Graduate Programme – Lisa’s story January 10th, 2020 5 minute read Starting a career in industry can be a daunting experience at any time of life, but especially when it is your first ...
Blogs Phastar Graduate Programme – One Year In! December 10th, 2019 5 minute read I am now one year into my graduate role at Phastar, and it has been one of the quickest years of my life. I joined Ph...
Blogs Data Science: Making Sense of Data November 1st, 2019 4 minute read The volume of digital data in healthcare is projected to increase more rapidly in the coming years than any other sec...
Blogs The Opportunities and Challenges of Basket Studies November 1st, 2019 4 minute read There has been a growing emergence in the utilisation of basket studies and it’s not difficult to see why. Progress i...
Blogs Data Management of Adaptive Trial Designs November 1st, 2019 3 minute read Traditionally, studies have been run with a process of study design, study conduct, study report. Whilst this is more...
Blogs Beyond the Hype: AI and Machine Learning in Clinical Trials and Healthcare August 19th, 2019 7 minute read There is considerable hype surrounding Machine learning (ML) and Artificial Intelligence (AI) yet despite that, these...
Blogs Meta-analysis in Clinical Trials August 19th, 2019 4 minute read In medical research, information on the outcomes of a treatment may be available from a number of clinical studies wi...
Blogs Data Integration for ISS/ISE August 19th, 2019 5 minute read Integration of data from a number of clinical trials for an Integrated Summary of Safety (ISS) and Efficacy (ISE) req...
Blogs Phastar’s Approach to Risk-Based Monitoring May 24th, 2019 4 minute read Data quality and integrity are key aspects of Good Clinical Practice (GCP) and sponsors are expected by regulators to...
Blogs Data Visualization: Customized Graphics and Combining Outputs May 24th, 2019 3 minute read It has become easier to produce customised graphics in SAS and to produce reports that combine outputs from several d...
Blogs Data Science at Phastar May 14th, 2019 3 minute read Understandably, there is considerable excitement around the field of data science particularly in relation to healthc...
Blogs Adaptive Trial Design: A Programmer’s View February 15th, 2019 4 minute read The FDA defines an adaptive design as …an adaptive design is defined as a clinical trial design that allows for prosp...
Blogs Adaptive Designs for Dose Escalation Early Phase Studies February 15th, 2019 5 minute read A key objective of Phase I dose escalation trials is to establish a recommended dose and/or schedule for an experimen...
Blogs Multiplicity August 28th, 2018 4 minute read Recently, an FDA industry guidance draft on “Multiple Endpoints in Clinical Trials”1 provided an overview of multipli...
Blogs Estimands – What’s All the Fuss About? August 28th, 2018 3 minute read The public consultation period for the ICH E9 (R1) addendum on estimands and sensitivity analyses to the guideline on...
Blogs Rare Diseases: Treatment and Controls August 28th, 2018 7 minute read A rare disease is defined by the European Union as one that affects less than 5 in 10,000 of the general population a...
Blogs Data Quality and CDASH January 3rd, 2018 3 minute read How do you define the importance of data quality in clinical trials? An accurate reflection of a subject’s experience...
Blogs Quality Deliverables – Phastar’s Programming Perspective January 3rd, 2018 3 minute read Quality is paramount to all programming work carried out at Phastar to ensure accurate reporting and analysis of clin...
Blogs Missing Data: Management and Prevention August 9th, 2017 3 minute read Data managers strive to produce high quality, reliable and intact data for analysis. Integral to this quality standar...
Blogs Interim Locks and DSMBs April 12th, 2017 3 minute read Special consideration needs to be given to providing data for interim locks and DSMBs during the course of a study. I...
Blogs Statistical Issues in Oncology Trials August 30th, 2016 4 minute read A key issue in assessing the efficacy of new drugs in oncology is getting the balance right between choosing a hard e...
Blogs Programming Issues in Oncology Trials August 30th, 2016 3 minute read Oncology trials are complex and require a different approach to trials compared with many other therapeutic areas and...