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Clinical Research Solutions

Maximizing Clinical Trial Success: Strategic Approaches for Adding EU Member States in CTIS

Strategic Guidance for Expanding Clinical Trials Across EU Member States with CTIS Expanding a clinical trial to additional Member States within the European Union (EU) Clinical Trial Regulation...

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Clinical Research Solutions

The Role of CROs in Clinical Research & Clinical Trials

Clinical trials are complex, resource-intensive, and heavily regulated endeavors that span months to years. For many pharmaceutical, biotechnology, and medical device companies, navigating this...

Clinical Research Solutions

FDA Inspection Readiness: Top Observations and How to Avoid a Form 483

For medical device manufacturers, FDA inspections are a critical component of regulatory oversight and quality assurance. Whether part of a routine surveillance program, pre-approval inspection, or...

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FSP Solutions

Recruitment Strategies in FSP: Building Agile Teams to Drive Clinical Success

Staffing has become one of the most critical and complex challenges in the success of Functional Service Providers (FSP) within clinical research. Whether you're launching a global Phase III study or...

The Moving Regulatory Landscape for Gene Therapy Trials in EU

Submitting a GMO Application for a Clinical Trial with AAV Viral Vectors Navigating the regulatory landscape for clinical trials in the European Union (EU) has become more streamlined with the...

Clinical Research Solutions

Orchestrating Excellence: How ProPharma Bridges Vendors to Deliver Unified, High-Quality Outcomes

Greater Than the Sum of its Parts An introspection on the complexities of ProPharma Medical Information working with clients and their other outside vendors. Drug development is rarely a one-company...

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Clinical Research Solutions

European Marketing Authorization Success: The Critical Role of Quality and Compliance

Entering the European market isn't just about gaining marketing authorization — it's about sustaining it. For life sciences companies, success hinges on a robust approach to quality and compliance,...

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Clinical Research Solutions

Pros and Cons of Working with a CRO

A Contract Research Organization (CRO) is a company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract...

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Clinical Research Solutions

Understanding the Roles of LPPV, QPPV, and the PSMF in Pharmacovigilance: A Guide for Marketing Authorization Holders (MAHs)

In today’s stringent regulatory landscape, the effectiveness of a pharmaceutical company’s pharmacovigilance (PV) system is supported by three key pillars: the Qualified Person for Pharmacovigilance...

Clinical Research Solutions

Mastering Clinical Trial Submissions in Europe: A Guide for Drug Developers

Launching a clinical trial in Europe is a complex but rewarding endeavor, requiring careful navigation of regulatory frameworks, ethical requirements, and submission processes. Recent regulatory...

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Clinical Research Solutions

FMEA Is Not a Crystal Ball: Why You're Missing Critical Risks in Medical Device Lifecycle Management

Imagine trying to predict how a medical device could cause harm—but you're only allowed to look at one failure at a time, with no context, interactions, or real-world complexity. It's like peering...

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Clinical Research Solutions

CMC Expectations During Drug Substance Transfer from Ex-US Manufacturers

Regulatory Drivers for US-based API Manufacturers Recent shifts in US tariff policies have introduced new pressure points in the global pharmaceutical supply chain, particularly for manufacturers...

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Clinical Research Solutions

FDA Audit Preparation 101: How to Prepare and Manage an FDA Inspection

Imagine for a moment that this is your current situation… You receive a frantic call from the receptionist at your facility. An Investigator1 from the Food and Drug Administration (FDA) has just...

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Clinical Research Solutions

Advancing Digital Transformation in Medicines: EMA's Successful ePI Pilot

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have recently concluded a successful pilot project on electronic product information (ePI), marking a significant...

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Clinical Research Solutions

Maximizing the Value of FDA Pre-IND Meetings for Successful 505(b)(2) NDA Submissions

For drug developers leveraging the 505(b)(2) pathway, the FDA Pre-Investigational New Drug (Pre-IND) meeting is a strategic opportunity that can shape the trajectory of an entire development program....

Clinical Research Solutions

The Joint Commission Adds Pharmacists to Survey Teams: A Step Towards Comprehensive Healthcare Quality

In recent years, healthcare has undergone rapid transformation, especially in how care is delivered, measured, and improved. One of the most significant players in ensuring quality healthcare...