Choosing a clinical data management CRO can feel challenging when many providers make similar claims about quality, compliance, and experience. However, the true differences between providers often only become apparent later in a study, when database lock deadlines are approaching, third-party data needs reconciling, or regulators are scrutinizing data quality and traceability. This blog explores […]

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 […]

Clinical trial oversight depends on the ability to access, interpret, and act on data quickly. Many organizations still face challenges with fragmented systems, delayed insights, and inefficient processes. Integrated analytics provides a more effective approach by combining data, technology, and expertise.  The growing challenge of complexity  Clinical trials have become significantly more complex over the past decade. […]

Clinical trials are generating more data than ever before, but more data does not automatically lead to better decisions. The challenge for pharmaceutical and biotech organizations is turning complex, fragmented datasets into clear, actionable insights.  Data visualization is playing an increasingly important role in addressing this challenge. By presenting clinical, operational, and safety data in intuitive, real-time formats, teams […]

Phastar is excited to be attending European Statistical Forum, 12 – 13 November in NH Budapest City, Budapest. Connect with us at our presentation or request a meeting below: Experiences of Utilizing the BOIN12 Method for Designing Rare/Small Population Oncology TrialsGiles Partington, Consultant Statistician13 November 2026 Schedule a time to meet below:

Phastar is excited to be attending PHUSE EU Connect, 15 – 18 November in Glasgow, Scotland Connect with us below or visit us at booth #31, our poster or one of our presentations to learn more about our solutions. Poster: The Mouse Behind the KeyboardChoe Floodgate, Senior Programmer I17 November, 17:30 GMT, Hall 2 | […]

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 […]

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 […]

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 […]

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, […]

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 […]

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 […]

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 […]

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 […]

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.  […]

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

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 […]

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, […]

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 […]

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 […]

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 […]

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 […]

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 […]

Introduction  Risk-Based Quality Management (RBQM) is revolutionizing the way clinical trials are managed, offering a modernized, efficient, and data-driven approach to oversight. Traditional methods that rely heavily on frequent on-site visits and 100% source data verification (SDV) are resource-intensive, costly, and often inefficient. RBQM applications streamline these processes, helping clinical operations teams focus on high-risk […]

Slides created by: Carly Baker, Director, Clinical Data Operations, and Kat Fogden, Principal Data Operations Programmer | Phastar Complete the form below to download the slides

In this article for ACRP Clinical Researcher, Professors Deborah Ashby and Jennifer Visser-Rogers discuss the challenges of data monitoring in complex clinical trials. Traditional methods are insufficient for trials with multiple variables like endpoints or treatments. Emphasising the importance of adaptable Data Monitoring Committees (DMCs) and collaboration among experts to handle these complexities effectively Prof Ashby and […]

Phastar’s Carly Baker, Director of Clinical Data Management, and Alice Wang, Principal Data Scientist, recently took part in a Data Management-focused Q&A for the ACRP’s Clinical Researcher June 2023 release (Volume 37, Issue 3). In a wide-ranging discussion the pair touch on the benefits of IDMCs in safeguarding participant safety and ensuring data integrity, as well […]

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

Currently, there is no widely adopted definition of Digital Health. At Phastar, we take a broad view and refer to Digital Health as the “use of technology in healthcare”, as it encompasses the use of computing platforms, connectivity, software, artificial intelligence, machine learning, and sensors for health care and related uses. Just 20 years ago, […]

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

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

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

Presented by: Kirsty Millar | Phastar Complete the form below to watch the webinar

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

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

London, UK and Cambridge, MA – June 24, 2019 – Phastar announced today that it has entered into a technology partnership with Medidata Solutions, Inc.. Phastar will deploy several solutions from the Medidata Rave Clinical CloudTM including Rave EDC, Coder, eCOA, and RTSM. The adoption of the Medidata Rave Clinical Cloud comes as Phastar continues […]

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

On Tuesday 24th July 2018, Phastar presented a webinar on the topic ‘Efficiencies when delivering a quality database’. The presenters were Sheelagh Aird, Head of Clinical Data Operations and Gillian Childs, Principal Data Coordinator. The webinar, hosted by X-talks and Medrio, demonstrated the importance of controlling the quality of a database right from study set-up. […]

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

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

Data managers strive to produce high quality, reliable and intact data for analysis. Integral to this quality standard is to ensure minimal or no missing data. Missing data may have different sources such as equipment failure, missed visits, death or withdrawal of a subject and is usually dealt with during the analysis by defined handling […]

Special consideration needs to be given to providing data for interim locks and DSMBs during the course of a study. It is crucial that the data provided for these milestones is as complete, accurate and up-to-date as possible because the outcome can have serious implications on the review and progress of the study.  It is […]