regulations

Clinical Research in Poland: Excellent Recruitment and DCT Adoption

Lukasz Wozniak joined the industry in 2005 working for CRO companies. He has been working independently since 2010 as a freelance clinical trial consultant contracted by pharmaceutical and CRO companies covering CRA and regulatory affairs positions. Overall, Lukasz has 16 years of experience in research and in recent years, he …

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The Benefits of Conducting a Clinical Trial in Spain

María López is a freelance clinical research consultant and part of TrialHub’s network of country advisors. She has 25 years of experience in clinical research both in medical devices and drug clinical studies. Over the years she has held different positions: field clinical monitor, clinical research associate, clinical trial manager, …

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Decentralized Clinical Trial Regulations: A 2022 Report

Decentralization in clinical trials is quickly turning into a must-have for companies that truly want to support patients, provide more convenience and reach recruitment goals. Decentralized clinical trials (DCTs) hold the potential to reach new, remote patient populations, innovate rare and orphan disease research, and accelerate medical discovery.  In order …

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How COVID-19 Changed Research: The Clinical Trials Landscape in China

Almost two years after COVID-19 broke out, the notoriously conservative clinical research space has changed significantly. At TrialHub we want to take a look at how individual regions are recovering and what has permanently shifted in how trials are now planned and conducted.  Our partners from Proswell Medical (a mid-size …

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The One Thing Your Decentralized Clinical Trial Strategy Is Missing

Recently, Maya Zlatanova’s article Decentralized Clinical Trials Across Europe: Regulatory and Other Practical Considerations was published in DIA’s Global Forum. The piece highlights the most important considerations for planning and conducting decentralized clinical trials in Europe – from the different ‘readings’ of EMA’s guidelines depending on the country to the mindset of the patients depending …

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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 …

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National Guidances for Conducting Clinical Trials During the COVID-19 Pandemic

FDA, EMA and many national drug agencies have issued national recommendations and guidelines for ongoing clinical trials. They are focusing on providing support for patients, sites and investigators during the COVID-19 pandemic. Many of these guidelines suggest avoiding sites visits whenever possible as well as advice for remote monitoring visits. …

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Home Healthcare Services for Your Virtual Clinical Trial: Europe

Home healthcare services are usually explored as an option for the elderly or people with disabilities. In times of a pandemic that quarantined all of us at home, however, patients involved in clinical trials can also benefit from them, all the while allowing researchers to keep collecting data. From administering …

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Home Healthcare Services for Your Virtual Clinical Trial: USA

Home healthcare services are usually explored as an option for the elderly or people with disabilities. In times of a pandemic that quarantined all of us at home, however, patients involved in clinical trials can also benefit from them, all the while allowing researchers to keep collecting data. From administering …

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