Guidance on the Management of Clinical Trials during COVID-19: How Countries respond

2020 began with a surprise for many people, industries and governments. The coronavirus outbreak turned the world upside down and became a global threat the likes of which we hadn’t experienced for ages. Unfortunately, the clinical research industry was also impacted severely mostly due to the social distancing measures recommended by national and global organisations …

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3 Factors CROs Consider Sponsors Rarely Think Of

Clinical Research Organizations (CRO) are the go-to partner for helping biotech and pharma companies to research, evaluate and launch their new brilliant idea of a novel compound or medical device. And in fact, the CRO market has been growing in the last few years and is expected to reach $44bln by 2021. You can see …

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Data sources in Feasibility for clinical trials | Part 2

In my last article about Feasibility, data sources are defined so that you can recognise the best ones and choose which ones to use. To summarise, no matter what data sources you use they should be: Accurate Meaningful All-encompassing   If you want to learn more about this, you can read my previous article: Today …

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Data sources in Feasibility for clinical trials? | Part 1

Feasibility for clinical trials is all about finding the right sources of data, being able to analyse them and then make decisions for country selection, sites and investigators, as well as patient recruitment strategies. It sounds simple and yet, when it comes to execution it’s very complicated. Therefore feasibility specialists have a lot of questions …

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Remote Monitoring of Clinical Trials: 6 Solutions for Your Study

Remote monitoring of patients is only one side of the coin. To make sure your operations move forward and to mitigate the risks that the Covid-19 pandemic poses on research, you also need to plan for remote monitoring of your clinical trial. Remote monitoring reduces costs and enables you to meet timelines even without the …

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How to measure patient enrollment (on budget and on time)

There are many questions when planning a clinical trial. But one of those questions is the main one: How many patients can we enroll? And the answer is everything but straightforward or easy to provide. Yet, answering this one question could mean the world to a biotech startup that just raised its funding and gives …

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Global Clinical Operations Director’s insights from 2008 and top lessons that apply during COVID-19

Estrella Garcia is with Almirall for 27 years and is currently their Global Clinical Operations Director. She was with the pharma company during the last financial crisis and went through some really hard times for the company. She shares with Maya Zlatanova, CEO of FindMeCure Ltd., the lessons she learned and that helped them not …

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The Do’s and Don’ts of Direct-to-Patient recruitment

Patient recruitment in clinical research accounts for 32% of trial budgets – the largest single driver of clinical costs. Despite the heavy spending, it remains a huge challenge for the industry and the future of therapeutic innovation causing 50% of delays in clinical trials. Even so, many sponsors still rely on the traditional methods and …

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How to refer patients to trials conducted virtually

In recent decades, patients’ interest in participating in traditional on-site clinical trials has diminished and their dissatisfaction has decreased. There are different reasons  – remoteness of clinics and specialists, cumbersome process, financial burden, etc. Although the industry has been discussing a switch to a more remote or virtual way of conducting research studies, this new …

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