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Early Collaboration with FDA for Novel Programs: Maximizing the Emerging Technology Program (ETP)
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Six Startup Questions to Discuss with Planned Sites Before Activation
Site startup for a clinical trial will always be a challenge. Why? While driving the study forward and gathering cross-functional expertise to operationalize a successful study, site startup is comprised of many unexpected hurdles that may get in the way of meeting clinical development milestones. Site activation is not an easy or rapid process. Based […]
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The Pillars of Driving Change with a Patient-Centric Focus
As a panelist at CORE (Clinical Operations Retreat for Executives) East, hosted in Chatham, Massachusetts, I had the privilege of participating in a lively discussion on the theme of driving change with a patient-centric focus. This session brought together a remarkable group of experts advocating for early patient engagement throughout the entire clinical development process, […]
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Time for a Change – How KASA Impacts Regulatory CMC Submission Strategy
Planning, assembling, and editing a Chemistry, Manufacturing, and Controls (CMC) dossier is a critical part of every clinical trial application and marketing authorization submission. Every CMC dossier requires the compilation of copious amounts of data from various departments (i.e., Research and Development, Manufacturing, and Quality). Regulatory and technical authors must then summarize these data according […]
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AI-Driven Transformation in Clinical Research
Halloran’s CORE East, a three-day intensive retreat for clinical operations executives and life science leaders, is the epicenter of a movement aiming to disrupt the traditional landscape of clinical research. The best and brightest came together and sought to revolutionize the drug development process and its impact on healthcare. A few sessions emphasized embracing the […]
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Boston Business Journal’s Power 50: The Movement Makers Selects Halloran
Boston (November 16, 2023) – The Boston Business Journal’s Power 50: Movement Makers is an annual list of professionals in the Greater Boston business area taking a stand, creating change, and taking actionable steps to work together to make Boston continue to grow as a place for equity, inclusion, and diverse points of view. The […]
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Getting Practical about Diversity in Clinical Trials
Clinical trials play a pivotal role in advancing medical research and innovation, serving as the testing ground for new treatments and therapies. However, for clinical trials to be truly effective, they must include a diverse range of participants representing all possible demographics that could potentially benefit from the treatment. But disparities in healthcare outcomes among […]
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Top 100 Women-Led Businesses in Massachusetts Bestowed Upon Halloran
Boston (November 3, 2023) – The Women’s Edge, together with its partner The Boston Globe, announce Halloran Consulting Group as part of their annual Top 100 Women-Led Businesses in Massachusetts list, recognizing honorees during a celebratory breakfast event. For a second year in a row for Halloran’s inclusion on the list, recognizing women-powered companies driving […]
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How to Fix What’s Broken with Clinical Trial Compensation
What is broken at clinical research sites? This question posed at CORE East, a three-day intensive retreat produced by Halloran and held in Chatham, Massachusetts, sought to gather answers. In particular, the panel “Clinical Research Site Barriers: What’s Broken and Where’s the Opportunity?” led by Katie McCarthy, Chief Innovation Officer at Halloran, brought together industry […]
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Revolutionizing Clinical Trials: A Patient-Centric Approach for a Better Tomorrow
In the vast landscape of clinical research, patients stand as the primary stakeholders, their needs and experiences at the core of the pursuit of better healthcare solutions. This truth was a theme throughout CORE East, a transformative three-day event hosted by the Halloran Consulting Group (Halloran). In particular, the panel, “Patients and Caregivers: Journeys of […]