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Early Collaboration with FDA for Novel Programs: Maximizing the Emerging Technology Program (ETP)
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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 […]
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Small Biotech and Pharma Dilemma – Three Steps to Remain Competitive on a Budget
While attending the annual SCOPE summit this year, listening to sessions and walking the exhibitor hall, a strong question, for me, resonated throughout the entire experience. That is, how can small biotech and pharmaceutical companies stay competitive within their realm by leveraging opportunities to advance clinical research while still navigating resource constraints? Let’s break this […]
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Pulling the Thread on FDA’s Master Protocol Draft Guidance
The U.S. Food and Drug Administration’s (FDA) draft guidance, Master Protocols for Drug and Biological Product Development, released on December 21, 2023, provides expanded recommendations on the design and analysis of trials conducted under a master protocol. A master protocol is a protocol designed with multiple substudies, which may have different objectives and involve coordinated […]
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Diversity in Clinical Trials: Shifting from Challenge to Innovation Opportunity
In the dynamic landscape of clinical research, ensuring diversity in clinical trials has emerged as a critical factor for the success for the healthcare ecosystem. Recently, I had the privilege to attend the 2024 SCOPE summit, where discussions around diversity in clinical trials sparked inspiration for future clinical trial design and shed light on its […]
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Five Broad Implications for FDA’s Project Optimus: The Future of Oncology Trials is Here
Oncology drug development is different from most drug development programs in other therapeutic areas, or at least, has been historically. While most drugs are evaluated in randomized dose-ranging trials prior to pursuing pivotal clinical studies, oncology drug development, by comparison, is often accelerated due to the life-threatening nature of most cancers and the inherent toxicity […]