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Early Collaboration with FDA for Novel Programs: Maximizing the Emerging Technology Program (ETP)
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Navigating the Maze: The Vital Role of Collaboration and Leadership in Phase 2 Clinical Trials
In the intricate world of pharmaceutical development, the journey from a promising compound to a market-ready drug is certainly not linear. Amongst the many small wins come obstacles and challenges. How those challenges are managed in pivotal moments often defines success versus failure. One pivotal juncture in this voyage is the phase 2 clinical trial—a critical […]
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Leveraging Outsourcing and Mixed Model Staffing Amid Layoffs: A Strategic Approach
In the dynamic landscape of business, layoffs or losing momentum in a program with faulty data can often feel like a shotgun blast, leaving organizations scrambling to realign resources and maintain productivity. However, amidst the chaos, there lies an opportunity to adopt a more strategic approach to workforce management. As a leader facing either the […]
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Navigating the Path to FDA Approval: The Importance of a PDUFA Date
As a biopharmaceutical company advancing through the phases of clinical development, each step brings excitement and challenges. The decision to request a review date from the FDA, known as a PDUFA date, marks a significant milestone in the journey toward drug approval. However, this milestone comes with its own set of responsibilities and pressures. Understanding […]
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Moving Towards Sustainability in Clinical Research – a Call to Action
The life sciences industry is becoming more focused on sustainability practices – a movement evident during the recent SCOPE summit. During my time at the event, I jumped at the opportunity to attend any session regarding advancing sustainability practices in clinical research. This is a subject of interest to me – not just from a […]
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Elevating Your Clinical Trial Audits with Artificial Intelligence and Centralized Monitoring
Clinical trial audits serve as a tool to assess if a given auditee has the required qualifications and capabilities to conduct a set of tasks. Auditing assesses standards and regulations that have or will be met. Clinical trial activities may be delegated to vendors or suppliers, including Contract Research Organizations (CROs), sample processing laboratories, Contract […]
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Quality Governance and Evolution of Quality Management Review
Quality governance can be defined as an overarching framework that provides assurance of compliance with regulatory requirements, industry standards, and continuous quality improvement while enabling the risk and issue escalation process. Quality governance structures and processes provide transparency to an organization’s leadership on how well the Quality Management System (QMS) is functioning. It is through the […]
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Bringing In Vitro Diagnostics to Market with Real-World Evidence
In vitro diagnostic (IVD) devices are a unique type of medical device. Although they meet the definition of a medical device, they are not intended to treat a disease or condition. Rather, they are the instruments or reagents that analyze samples taken from patients. IVDs are less invasive than traditional medical devices, but still present […]
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Preparing Now for FDA’s START Program for Rare Disease Drug Developers
On September 29, 2023, the U.S. Food and Drug Administration (FDA) took action to help further accelerate the development of novel drug and biological products for rare diseases. The action, an announcement of an opportunity for a limited number of sponsors to participate in a pilot program (Support for Clinical Trials Advancing Rare Disease Therapeutics […]
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In Memoriam: Laurie Halloran, BSN, MS, Visionary Leader, Passes Away
FOR IMMEDIATE RELEASE March 1, 2024 In Memoriam: Laurie Halloran, BSN, MS, Visionary Leader, Passes Away Newton, MA – The family of Laurie Halloran, along with her colleagues at Halloran Consulting Group, sadly announced the peaceful passing of Laurie on February 29. Beloved Mother of Three Sons, Wife, Daughter, Aunt, Friend, and Mentor Laurie Halloran […]