European Union Flags Flying In Front Of Building in Brussels

Clinical Research Solutions

Navigating the New EU Health Technology Assessment Regulation (HTAR): Are You Ready?

The HTAR in the EU has come into force – what Health Technology Developers (HTDs) need to know Getting your health technology product to the market is complex and usually consists of several steps...

healthcare-professional-on-tablet

Clinical Research Solutions

German Pharmaceutical Compliance: The Critical Role of Medical Information Teams

When a pharmaceutical company completes clinical trials and prepares to launch a medical product, the focus often shifts to regulatory approvals, market access, and commercialization. However, one...

child-receiving-medical-care-rare-disease

Clinical Research Solutions

The End of the FDA's Rare Pediatric Disease Priority Review Voucher Program

What’s Next for Rare Disease Innovation? For children suffering from rare and often life-threatening diseases, access to new and effective treatments can mean the difference between life and death....

Clinical Research Solutions

Signal Detection and Management - The Pursuit of Safer Products

Signal detection for products in development Why signal detection in clinical development? Early safety signal detection enables: Early identification of safety risks Informed decision making Meets...

Doctor holding a patient's hand over a desk

Clinical Research Solutions

Challenges in Clinical Development of Products for Rare Disease

Rare diseases are defined in the Orphan Drug Act as diseases or conditions that affect less than 200,000 people in the United States. There are over 7,000 rare diseases affecting more than 30 million...

Clinical Research Solutions

Leveraging Single-Arm Trials for Regulatory Approval: Insights from EMA's Reflection Paper

The pharmaceutical industry has shown a growing interest in single-arm trials due to their potential to expedite drug development. However, several challenges and concerns remain. The European...

Clinical Research Solutions

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....

European Union flags outside of EU parliament

Clinical Research Solutions

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...

Clinical Research Solutions

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...

FDA Recommendations for Confirming an Ames Positive Finding

Clinical Research Solutions

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...

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