eConsent
Wien, 01.09.2024 – Text: Catarina Carrão Introduction eConsent refers to the process of obtaining informed consent from participants in clinical trials using electronic systems and processes. This method involves using electronic tools, such as tablets, computers, or smartphones, to present information about the trial and to collect signatures from participants. Misconceptions eConsent and remote consent are often confused, […]
Clinical Performance Evaluation of IVDs
Wien, 01.08.2024 – Text: Catarina Carrão In vitro diagnostic (IVD) medical devices In vitro diagnostic (IVD) devices play a critical role whether to help diagnose diseases or conditions, monitor health status, or guide treatment decisions. For these reasons, a new Amending Regulation [EU 2024/1860] was published in July 2024 to extend the IVDR transition timelines while […]
Clinical evidence: essential for both investors and regulators
Wien, 09.07.2024 – Text: Catarina Carrão Medical technology start-ups: popular demand The need for innovative healthcare solutions is high, as such medical technology start-ups are increasingly popular. Whether developing new technologies, devices, and/or software that has the ability to improve patient outcomes and reduce healthcare costs, the incentive is there to identify a niche and develop something new. However, […]
Orphan medical devices: balancing the needs for clinical evidence
Wien, 02.07.2024 – Text: Catarina Carrão Rare diseases in the EU In the European Union (EU), 27 to 36 million people live with one of the estimated 6,000 to 8,000 rare diseases, which can affect anywhere from a few patients to as many as 245,000.1 Approximately 80% of these diseases are genetic, with 70% beginning […]
Is the Clinical Trials Enterprise broken and how can we fix it?
A report of the inaugural JAMA Summit Wien, 17.06.2024 – Text: Catarina Carrão The inaugural Journal of the American Medical Association (JAMA) Summit 1 was held last October and focused on clinical trials, the basis of evidence-based medicine. It was meant to address the provocative questions: Is the Clinical Trials Enterprise Broken? And How Can It Be Fixed? As such, an international group of invited clinical researchers, funders, regulators, policymakers, […]
International Clinical Trials Day: Data Centric Clinical Research
Wien, 20.05.2024 – Text: Catarina Carrão International Clinical Trials Day In May 2005, the European Clinical Research Infrastructures Network (ECRIN) begun celebrating the International Clinical Trials Day. This celebration yearly brings together patients, health policy actors, health authorities, clinical researchers, health professionals and citizens from across Europe and beyond to discuss issues related to multinational […]
Implementing the EU Health Technology Assessment Regulation (EU HTAR)
Wien, 24.04.2024 – Text: Catarina Carrão The development of health technologies is a key driver of economic growth and innovation in the European Union (EU), since health technologies constitute an innovative sector of the economy and form part of an overall market for healthcare expenditure that accounts for 10 % of the EU gross domestic […]
EU CTR: Transparency
Wien, 15.04.2024 – Text: Catarina Carrão In the end of January 2022, the EU CTR (EU/536/2014) came into effect within the European Union (EU), replacing the EU Clinical Trials Directive (2001/20/ EC). Under the EU CTR, a new EU database – the Clinical Trials Information System (CTIS) was created to provide a single-entry point for […]
EU MDR and The Need For Clinical Evidence
Wien, 12.03.2024 – Text: Catarina Carrão Since the establishment of the EU Medical Devices Regulation (MDR EU 2017/745), Notified Bodies (NBs) have their hands full evaluating the clinical evidence for such products as a critical step for manufacturers to renew or obtain a green door to the European Economic Area (EEA) market. Clinical evaluation: where […]
From EMA for Pharma SMEs: Updated User Guide
Wien, 15.02.2024 – Text: Catarina Carrão On the 23rd of January 2024, the European Medicines Agency (EMA) released a major revision of its user guide for micro, small and medium-sized enterprises (SMEs) in the pharmaceutical sector. The revised guide offers a comprehensive view on the European Union (EU) legislative framework for medicines, outlining requirements for the development and authorization of medicines for human use. Take a look at the […]
