‘First’ Therapeutic Approvals Bring Patients Hope
When novel drugs and biologics hit the market, the treatment horizon for many patients is suddenly broadened. US Food and…
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Advancing Towards Human Challenge Studies with the SARS-CoV-2 Virus
The current COVID-19 pandemic, caused by the novel coronavirus SARS-CoV-2, is the current focus of numerous drug therapies and vaccine…
Remote Monitoring to Keep Clinical Trials Running Amid COVID-19
At the peak of the COVID-19 pandemic, clinical study monitors and patients were restricted from sites. Sponsors and CROs had…
Pharmaceutical Cold Chain Expertise – the Missing Ingredient in the CMO/CDMO Offering
Within this evolving world of biopharma, it is estimated that two-thirds of biopharmaceutical manufacturing is outsourced. Therefore, the supplychain is…
Why Aren’t More Life Sciences Companies Automating PV Data Capture?
The pressures on pharmaceutical organisations to capture, sift and process real-world adverse event data are immense – and soaring. So…
Coronavirus and Contact Tracing Apps: The Italian Case
Contact-tracing apps and technologies are a hotly debated issue with legal, medical and technological implications. The most common mistake in…
The Global Regulatory Landscape for Clinical Trials Considering the COVID-19 Pandemic
The outbreak of COVID-19 created unprecedented circumstances for the conduct of clinical trials across the world. While the industry has…
To Participate or Not Participate: Why Do Investigators Reject a Clinical Research?
Clinical research is a complex, expensive, and time- and resourceintensive process. Feasibility assessments play a crucial part in this clinical…
Clinical Evaluation and Post-marketing Surveillance of Medical Devices in the USA
The medical device industry makes a colossal number of items ranging from invasive gloves to non-natural joints to imaging gear…
The Immense Potential of Africa’s Advantageous Landscape
The low representation of African countries in clinical trials is not unusual. Poor visibility of existing sites, limited infrastructure, cultural…