On 20th May 2025, I attended the Research and Development Forum (RDF). The conference took place at the Manchester Central Convention Centre and was attended by clinical research professionals. In…
Continue readingTrials that were authorised under the Clinical Trials Directive 2001/20/EC through EudraCT and are to be transitioned to CTIS are called Transitional trials. Clinical trials authorised under the CT Directive…
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 readingThere has been growing interest in implementation of pragmatic approaches in clinical trials. Especially for enhancement cancer research conduct including regulatory communications and ultimately patient care, where the use of…
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 readingRecently I attended the bi-annual meeting organised by the Institute of Clinical Research – GCP Forum. We had the pleasure to have the senior GCP inspector at the MHRA, Andrew…
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 readingFDA have released a final guidance regarding informed consent requirements for clinical trials. This guidance is applicable not only for medicinal products but for medical devices too. In this summery…
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 readingThere is an ongoing public consultation by the World Health Organization which aims to update its guidelines on clinical trials. There are some really good recommendations in the draft guideline…
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