Rethinking Biometrics Resourcing in Modern Clinical Trials
Rethinking biometrics as a strategic function to improve consistency, scalability, and clinical trial performance.
Quality & Compliance
Staying Ahead: Why BIMO Inspection Readiness Audits Are Essential for Clinical and Biological Research Compliance
In the world of clinical and biological research programs, ensuring compliance with regulatory standards is not only essential for maintaining the integrity of studies but also for safeguarding the...
Regulatory Sciences
Drug Development: The Key to Success from Concept to US Commercialization
Congratulations! You have a lead candidate formulation for your new drug. You might be thinking to yourself, “okay, now what?” We all know the science and effort to get to this stage is significant....
Medical Information
The Importance of Social Media Monitoring in Pharma
In today's digital age, social media has transformed how businesses communicate with their audiences. For pharmaceutical companies, this shift presents both challenges and opportunities. Social media...
Clinical Research Solutions
Pre-Approval Inspection (PAI) Readiness is Easy, Right?
Facing a pending filing and subsequent PAI can feel overwhelming, no matter if you are a young firm or an established company. You're balancing the excitement of bringing a new product to market with...
Regulatory Sciences
European Pharma Regulations: 2024 Review and 2025 Trends to Watch
Gaining a Competitive Edge: 2024's European Pharma Regulatory Review & Trends to Look for in 2025 and Beyond As the pharmaceutical landscape in Europe evolves rapidly, regulatory frameworks are...
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...
