The Health Sciences Authority (HSA) is Singapore’s national regulatory agency responsible for ensuring the safety, quality, and efficacy of health products, including the oversight of clinical trials. HSA reviews and…
Continue readingTo conduct a clinical trial in China, applicants must obtain approval from both an Ethics Committee (EC) and the National Medical Products Administration (NMPA). The Center for Drug Evaluation (CDE)…
Continue readingThis is our discussion with Steven Edmunds which was recorded for the Solutions OP Clinical Trials podcast. You can listen to the original recording here. Please note that the interview below is adapted and…
Continue readingThis is Olga Peycheva overview of FDA CMC Pilot webinar which was held on 10 Sep 2025 and was recorded for the Solutions OP Clinical Trials podcast. You can listen to…
Continue readingThis is our discussion with Harry Henson which was recorded for the Solutions OP Clinical Trials podcast. You can listen to the original recording here. Please note that the interview below is adapted and…
Continue readingThis is our discussion with Lydia Ainsworth which was recorded for the Solutions OP Clinical Trials podcast. You can listen to the original recording here. Please note that the interview below is adapted…
Continue readingConducting clinical trials of pharmaceuticals or medical devices in Taiwan requires prior regulatory and ethical approval. Except for trials classified as having no significant risk, all clinical investigations must be…
Continue readingThis is our interview with Georgi Kadrev which was recorded for the Solutions OP Clinical Trials podcast. You can listen to the original recording here. Please note that the interview below is adapted and…
Continue readingOur podcast is now available on YouTube. You can find all our old episodes as well, however we will provide links to our latest interviews below:
Continue readingOur article with recommendations for improving the informed consent forms (ICFs) for medical devices clinical trials is now out. The purpose of our work was to provide overview of the…
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