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Early Collaboration with FDA for Novel Programs: Maximizing the Emerging Technology Program (ETP)
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Should You Bring Your Trial Master File In-House?
A Trial Master File (TMF) is an ecosystem of documents used by monitors, auditors, assessors, and sponsors to demonstrate that a clinical trial has been conducted in compliance with Good Clinical Practice (GCP) and the approved protocol. The TMF is an essential quality process, enabling documentation of all activity that has been performed during the […]
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Success Planning for an Original NDA / BLA Submission
This comprehensive webinar offers an insightful exploration into the intricate landscape of New Drug Applications (NDAs) and Biologics License Applications (BLAs), elucidating the pivotal regulatory procedures imperative for pharmaceutical companies seeking approval for novel drugs and biologics. Its primary objective is to equip participants with the requisite knowledge and resources essential for navigating the intricate […]
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Critical Steps Towards a Collaborative Partnership and Governance Model
When crucial clinical trial activities are delegated by a sponsor to their vendor, the sponsor must take measures to ensure the vendor or subcontractor is delivering the agreed-upon services. This is effective vendor management in clinical trials, requiring careful selection and review of the vendor’s qualifications. Of importance is the sponsor’s continuous oversight of the […]
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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 […]