A biotech CRO is a contract research organization that runs clinical trials for biotechnology companies — usually small ones, developing one or two assets, with no in-house clinical operations department. The regulatory work is identical to what large pharma requires. The constraints are not: one asset instead of a portfolio,...
Read more ▸A CRO (contract research organization) — is a company a sponsor hires to run part or all of a clinical trial: study design, regulatory submissions, site selection, monitoring, data management, statistics and the final report. The sponsor keeps legal responsibility; the CRO performs the transferred duties under contract. That split...
Read more ▸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...
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