Why Do We Need Diversity Plans In Clinical Trials?
1.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….
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China Medtec 2024 Through the Eyes of a Visitor
Our latest interview is with our Clinical Research Partnerships Manager, Wai Theng Lee, who attended the 20th edition of China Medtec 2024 together with our Regulatory and Study Start Up…
Continue readingOverview: Bridging Cancer Research with pragmatic model approaches
There 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 readingClinical Trials Information System (CTIS) Overview
CTIS 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 readingLondon Digi-Tech Pharma & AI 2024: Participant perspective
On 28th and 29th May 2024, I attended the Digi-Tech Pharma and AI conference in London. This was a much smaller conference compared to the Oncology Professionals Conference I attended…
Continue readingGlobal AI conference (22-23April 2024) – Skin diagnostics
This has been my very first Artificial Intelligence (AI) type of conference that I recently attended. AI is a broader subject and in recent days many new developments have been…
Continue readingOverview of MHRA GCP Inspection findings and other challenges – April 2024
Recently 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 readingChallenges And Benefits of Remote vs. On-site Monitoring
Monitoring visits are a crucial part of clinical trials, allowing trial data in eCRFs to be checked for accuracy and completeness against source data at sites. Monitors may also check…
Continue readingWhat is changing in the UK MDR?
MHRA organised a very informative webinar on 5th of Mar 2024 to provide update on the upcoming changes in the UK Medical Devices Regulation (UK MDR). They mentioned several reasons…
Continue readingThe Latest Pilots from MHRA in 2023 and How They Could Help You
There are a lot of pilots that MHRA started back in 2023. This is a short summary of the new initiatives and how they can be helpful for pharma and…
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