Sponsors comparing contract research organizations usually run into three tiers: small niche specialists, global full-service giants, and a middle segment between them. "Mid-size" is not a loose description – it is a recognised market segment with its own operating model and its own trade-offs. This article explains what defines the...
Read more ▸CTIS Submission Services under EU CTR The EU Clinical Trials Regulation (EU CTR 536/2014) established a unified framework for the submission, assessment, and supervision of clinical trials across the European Union. At its core lies the Clinical Trials Information System (CTIS) — a single portal that centralizes communication between sponsors, Competent Authorities, and Ethics Committees....
Read more ▸Why the FSP model matters today Clinical trials keep getting more complex - more countries, more vendors, more data sources, and tighter timelines. At the same time, regulators expect sponsors to maintain documented oversight of important trial activities that are delegated to service providers, even in highly outsourced programs. In...
Read more ▸Introduction to observational studies Observational (non-interventional) studies capture what happens in routine clinical care. Patients stay on their usual treatment pathway, and researchers collect outcomes, safety information, and utilisation patterns without assigning an intervention. That’s the key difference from interventional clinical trials, where the protocol actively tests a treatment or procedure. Because...
Read more ▸Software as a Medical Device (SaMD) is no longer a futuristic concept — it’s a fast-growing reality. From smartphone-based cardiac monitors to cloud-native diagnostic algorithms, software that performs medical functions independently of hardware is reshaping clinical practice. But with innovation comes responsibility. Because SaMD can directly influence patient outcomes, it’s...
Read more ▸What Is SaMD Certification and Why It Matters Software as a Medical Device (SaMD) refers to software that performs medical functions — such as diagnosis, monitoring, or clinical decision support — without being part of a physical medical device. SaMD certification is a critical requirement for entering regulated markets like...
Read more ▸Definition and Regulatory Implications Software as a Medical Device (SaMD) can exist not only as a standalone medical tool but also as an accessory to a physical medical device. In this role, the software is not intended to operate independently but to support, drive, or supplement the primary device’s function....
Read more ▸Definitions SaMD (Software as a Medical Device) SaMD refers to software intended for medical purposes that operates independently from any hardware medical device. It performs medical functions on its own, without being embedded in a physical product. Examples include AI-powered diagnostic tools, mobile applications for disease risk assessment, or cloud...
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