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….
Continue readingClinical Trials Set Up
Clinical 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 readingOur statistics for 2022-2023
The 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 readingThe Major Pitfalls in Clinical Trials Set Up
All 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 readingThe Undervalued Role of the Clinical Research Associate
Back 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 readingFree consultation for products developed in China
Do 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 readingBitesize Regulatory News 5 Oct 2021
USA 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 readingSimplifying Oncology Informed Consent in Clinical Trials
Current 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…
Continue readingClinical Trials and Restricted Medications
During my recent work I came across 2 cases of usage of restricted medications in patients participating in clinical trials. In both cases restricted medications were prescribed by GP or…
Continue readingWhat Are the Criteria for Enrolling People with Intellectual Disabilities in Clinical Research?
It is generally accepted that people with intellectual disabilities are not considered in clinical research if the type of the disease could be studied with people without disabilities. The reasons…
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