MDR 2025: What’s Really Changing and How to Prepare Now
The MDR deadline extension is not a pause. It’s a strategic opportunity – but only if you act early. Back in early 2024, the European Commission granted more time for companies to align with Regulation (EU) 2017/745 (MDR) – particularly concerning legacy devices. While many manufacturers welcomed the extra breathing room, be careful: more time doesn’t mean fewer…
GCP R3 – Episode 1: What you need to know (Especially if you work in MedTech)
GCP R3: GCP is evolving, are you? The ICH has released the E6(R3) revision of Good Clinical Practice (GCP), and it marks a turning point. With this update, the rules of clinical evidence have changed, and if you’re working on medical devices, SaMD or digital health, you’re in the game now too. No need to worry, here’s a…
MDR – Racing Against Time for Your CE Mark
The extension is here, but it’s not a safety net. Learn how to move fast, stay compliant, and protect your market share. With Regulation (EU) 2023/607, the European Commission has introduced a critical extension to MDR deadlines for legacy devices certified under the previous MDD (Directive 93/42/EEC). It’s a valuable opportunity—but not an excuse to delay.…
AI and Automated Systems in Clinical Research: Support, Limits, and Why the CRA Cannot Be Replaced
Artificial Intelligence (AI) and automated systems are transforming the clinical research sector, improving data collection and analysis, optimizing decision-making processes, and reducing study time and costs. However, while these technologies offer valuable support, it is essential to understand that they cannot replace the Clinical Research Associate (CRA) nor human judgment. At We4CR, we use AI…
How to Streamline Ethics Committees for Faster Clinical Research in Italy
Clinical research is a fundamental pillar for the progress of medicine and the development of new therapies. The role of the Ethics Committees (ECs), independent bodies responsible for evaluating and approving trials, is a crucial element in ensuring ethical and safe clinical trials, ensuring that participants’ rights, safety and well-being are protected. In the past, the fragmentation…
We4 Clinical Research Prepares for the Gender Equality Certification: Our Commitment to an Equitable and Inclusive Work Environment
In recent years, the issue of gender equality has taken on central importance. Companies are actively working to ensure equal opportunities, pay equity, and inclusive environments where every employee can fully realize their potential. At We4 Clinical Research, we firmly believe that valuing diversity is essential for driving innovation, productivity, and sustainable growth. Towards the…
When Tech meets Empathy: Designing tools that truly works for people
“The great myth of our times is that technology is communication.” – Libby Larsen We often celebrate technological progress as if it were an end in itself. But in clinical research, tech that doesn’t connect with people quickly shows its limits.True innovation happens when technology and empathy work together, enabling research teams not just to…
FDA vs EU: how to keep up with confusing regulations
Future is now. What we used to imagine as something for the year 3000 is already here, woven into our everyday life. Technology has reshaped our habits so profoundly that it’s hard to remember how things worked before. In clinical research, this transformation has been nothing short of pivotal. From Artificial Intelligence (AI) to Software…
The Expert Take | When RCTs aren’t the best choice: finding the right study design for Medical Devices
“RCTs are the gold standard.” That’s the mantra we all know in clinical research, and it’s true. Or rather, almost true. Because when it comes to medical devices, that model starts to crack.Devices live in a reality that’s dynamic, operator-dependent, and constantly evolving.Recognizing when an RCT isn’t the right choice doesn’t mean lowering the bar: it means…
Beyond automation: when technology takes shape around people
There’s a moment at the start of every clinical project when everything begins to take shape.A protocol comes to life, timelines become real, and a team starts building trust. That’s the moment technology enters the picture: not to dictate the rules, but to listen. Because no matter how advanced a platform is, technology only makes…
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