Conducting 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 Tommaso Prosdocimi from Iperboreal Pharma which was recorded for Solutions OP Clinical Trials podcast. You can listen to the original recording here. Please note that…
Continue reading1.What is a Diversity Plan? In order to know if a new drug or medical device works in specific patient population, we need to have data generated from clinical research….
Continue readingCTIS supports clinical trials sponsors to apply for clinical trial authorisation in up to 30 European Union (EU) countries (member of states) with a single application process. Clinical Trials (CTs)…
Continue readingThe last year has been very successful for our team. We are grateful that in such challenging times for many businesses, we had the opportunity to set up and manage…
Continue readingAll of us working in clinical trials set up are acutely aware of the phrase ‘… so you can just do the submission and we will handle the rest’. Many…
Continue readingBack in the days when all data in the clinical trials was on paper only, pharmaceutical companies had representatives called Clinical Research Associates (CRAs) who were responsible for visiting the…
Continue readingDo you have product developed in China? This could be new therapy, medical device, cosmetics, food supplements and many more. Are you planning to submit clinical trial in UK but…
Continue readingUSA FDA has issued a new draft guideline for safety reporting which is expected to be finalised in Nov 2021. In the new edition they acknowledge that clinical trials are…
Continue readingCurrent expectations are that by 2030 the annual new cancer cases will reach 22.2 million people. There is an urgent need of new more efficient therapies to tackle raising cancer…
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