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Clinical research coordinators (CRCs) – a CRC is not a clinical research associate but one is frequently mistaken for the other – have a fundamental role in clinical research. Their work involves a wide range of activities and responsibilities in…
The etiquette in clinical trial research requires companies to respect rules and to be precise and accurate. The new EU Clinical Trials Regulation 536/2014 (EU CTR) pushes companies and health authorities one step further – to be more flexible and…
The EU’s new Medical Devices Regulation and In-vitro Diagnostic Device Regulation has integrated and reinforced the regulatory requirements for pre- and post-market clinical trials and positioned them as vital to ensuring the safety and performance…
The Investigator's Brochure (IB) is a multidisciplinary document that summarises the main elements of an entire development programme to date. Although the IB also serves other purposes, it is primarily written to enable investigators conducting…
In January 2021, the single market of medicines of the Eurasian Economic Union (EAEU) was launched. This article describes the current status of the transition to unified rules for the registration of medicinal products and the main regulatory…
Clinical trials are becoming more complex and the efforts to optimise drug development are rapidly evolving. This Q&A gives a short overview of the strategies Bristol Myers Squibb implements to incorporate diversity into the clinical trial…
With the introduction of new clinical trial transparency regulations around the world, transparency functions have had to adapt to a range of reporting requirements. In 2007, the FDA Amendments Act (FDAAA) established requirements for trial sponsors…
Clinical study reports (CSR) are detailed documents that provide a comprehensive and transparent account of the conduct and results of a clinical trial. They are an important source of information for the regulatory authorities, healthcare…
The clinical research landscape is gradually changing as we enter the era of big data. Big data sources are multiplying as existing sources collide to create expanded platforms that serve wider areas of expertise. Clinical study designs…
Cancer is currently a high-priority area for drug development. Most cancers are immediately life-threatening diseases demanding urgent treatment and therapies are usually highly toxic. This poses a range of specific challenges for the ethical…
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