M Carscadden

Causal inference is increasingly used to generate real-world evidence (RWE), by regulatory bodies and health technology assessment. This webinar introduces what is required to support causal claims, how causality can be evaluated across different study designs, and why this shift is particularly relevant for RWE today.   Speakers: Ryan Batten, Senior Statistician Josh Enxing, Senior Programmer- Moderator Learning Points: Distinguishing correlation from causation in the context of clinical and […]

As the pharmaceutical landscape evolves, traditional clinical trial designs are increasingly complemented by innovative, data-driven approaches. Real-world data (RWD) offers the potential to augment trials, simulate patient populations, and generate synthetic control arms. In-silico trials, powered by RWD and advanced analytics, help provide a path to faster, more efficient, and highly informative drug development. This […]

Use of external data to augment clinical trials has been increasingly evaluated and is transforming drug development paradigms.   Numerous innovative methods including hybrid designs, Bayesian borrowing and disease modeling have been developed, raising the new regulatory question: “Is the data we observe similar to the data we predicted or intended to include?”    The […]

The demand for rapid, cost-effective, and standards-compliant SDTM delivery continues to increase across the biotech and pharmaceutical industry. While company level SDTM standards and SAS macro-based solutions have fulfilled the needs for many years, they can still be restrictive and less adaptable in today’s evolving trial landscape and performance requirements.  This webinar series will discuss the practical […]

The early stages of clinical development are critical, decisions made here can determine the efficiency, cost, and ultimate success of an entire program. With the evolving landscape of early phase drug development, sponsors need flexible yet robust statistical approaches to ensure that promising compounds are evaluated effectively and efficiently. Getting this stage right not only […]

Real-world data (RWD) are transforming clinical research. By supplementing randomized controlled trials (RCTs), RWD can de-risk studies and improve generalizability. Innovative designs, from hybrid RCTs to registry-based trials, are gaining traction, with regulators setting clear standards for their use. This webinar shares case studies, practical methodologies, and key considerations to help you apply RWD effectively […]

Data Monitoring Committees (DMC) are a critical part of the clinical trial process, independently assessing the safety of an investigational product and at times the futility/efficacy. Successfully navigating DMC set-up, logistics, and independent data review can be complex, especially for biotech and smaller sponsors without in-house expertise.  Speakers: Lucy Clark, Statistics Manager Lisa Gibbons, Senior […]

As a follow-up to Clinical Trials Day 2025, with the theme of being “Powered By Purpose,” industry thought leaders shared their perspectives with ACRP on their clinical research powers, and on what they see as being the greatest current challenges and opportunities facing the field today. In June’s issue ACRP Clinical Researcher, Phastar’s Chief Operating […]

Sponsors working in rare diseases/running small population studies often have difficulties in demonstrating efficacy due to the small number of patients available for analyses. Bayesian methods offer promising solutions for small population and rare disease trials where leveraging available data can provide important insights and evidence. Discover the importance of Bayesian trial designs and the […]

Introduction  Patient reported outcomes (PRO) have been used in clinical trials for many years, but it is only recently that electronic (ePRO) collection has become possible. The advantage for trials is the potential for on-the-spot measurement of endpoints that are characterized as a set of symptoms, reportable by patients. This decentralized data collection has the […]

Real World Evidence (RWE) plays a critical role across multiple pharma processes, including drug development, regulatory decision-making, precision medicine and health economics, providing valuable insights from actual clinical practice. In order to leverage these data effectively and make informed decisions, sponsors need to be aware of the types of data that are available and the […]

EU HTA regulations are changing the way we conduct HTA submissions with EU regulators. Prior to the introduction of this legislation, submission to each member state’s regulatory body could be done in a staggered approach. This won’t be the case with EUnetHTA. Read our latest article on the impact of these changes and how Phastar […]