AI-Readiness 101: AI Success Starts with Understanding Your Data
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Medical Information
Optimizing Clinical Trials: Balancing Patient Experience and Commercial Outcomes with Concierge Services
As therapies for rare diseases evolve, clinical trials increasingly require patient -centric care to ensure a smooth and supportive participant experience. This shift is crucial not only for...
Quality & Compliance
WHO Issues Guidance on Antibiotic Pollution Control
On September 3, 2024, the World Health Organization (WHO) released its first guidance to mitigate antibiotic pollution from manufacturing. This directive, which outlines wastewater and solid waste...
Medical Information
Excelling in the JAPAC Medical Information Landscape: Key Considerations and Insights
As a rapidly expanding market, the Japan and Asia-Pacific (JAPAC) region presents a unique and complex landscape for those who are looking to establish a medical information (MI) function. Having a...
Regulatory Sciences
Nonclinical Drug Development: FDA Recommendations for Confirming an Ames Positive Finding
On November 27,2024, FDA released a draft guidance intended “to inform industry and the review staff in the Center for Drug Evaluation and Research (CDER) on how CDER views positive findings in the...
Regulatory Sciences
Navigating Market Access & Reimbursement Strategy for Medical Devices in Europe
Background Developing medical devices (MDs), including in vitro diagnostic medical devices (IVDs), requires careful and result-oriented planning throughout the development process. One critical...
Regulatory Sciences
FDA Releases Final ICH M13A Guidance Document
On October 31, 2024, FDA issued its final version of the ICH M13A guidance for industry, titled “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms”. This guideline provides...
Quality & Compliance
The Evolving Landscape of Quality Management Systems in the Life Sciences Industry
In the decades since the FDA first introduced Good Manufacturing Practice (GMP) regulations, the drug and device industry has undergone significant transformation. While the core principles of...
Medical Information
A Journey Through ProPharma's REMS Program Support
This fictional story illustrates how ProPharma can seamlessly support a REMS program to ensure patient safety, access to medication, and regulatory compliance. Through scenarios involving healthcare...
Digital Transformation
Evolving at the Speed of Science: How to Future-Proof your Benchling Platform
Science and technology are evolving rapidly, with an explosion in machine learning (ML) and artificial intelligence (AI) creating new possibilities for scientific discovery, operational efficiencies,...
Quality & Compliance
Breaking the Chains of Project Management Dysfunction
Right now, you are sitting in front of your computer and wondering how, based on current project status, you will achieve your remaining project goals for the year or achieve those planned for the...
Medical Information
Patient Support Programs in India: Overcoming Barriers with Healthcare Access
Current Landscape of Medication and Healthcare Access in India India's healthcare system is a complex landscape with significant disparities in access to medical services and medications. Despite...
Medical Information
Checklist for Building a Successful Risk Evaluation and Mitigation Strategy (REMS) Program
What is REMS? A Risk Evaluation and Mitigation Strategy (REMS) is a critical component of modern pharmaceutical regulation, designed to ensure that medications with serious safety risks are used...
Quality & Compliance
Meet the Expert: Andrew Bright
Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...
Regulatory Sciences
Act Now! Navigating the Windsor Framework in the UK
A New Era for Pharmaceutical Development and Licensing in the UK The Windsor Framework, set to be implemented from January 1, 2025, marks a significant shift in the regulatory landscape for...
Medical Information
What are Patient Support Programs?
Patient Support Programs (PSPs) in the pharmaceutical sector offer a range of services to help patients start and adhere to their therapies, including Patient Assistance Programs (PAPs), patient...
