Current Edition

‘First’ Therapeutic Approvals
Volume 12 Issue 4

‘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 Drug Administration (FDA) ‘firsts’ can …

Continue Reading →
Advancing Towards Human Challenge Studies
Volume 12 Issue 4

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 candidates. We have seen swift …

Continue Reading →
Remote Monitoring to Keep Clinical Trials
Volume 12 Issue 4

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 to reassesshow to keep trials …

Continue Reading →
Pharmaceutical Cold Chain Expertise
Volume 12 Issue 4

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 not only complex, but also …

Continue Reading →
Why Aren’t More Life Sciences Companies
Volume 12 Issue 4

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 why are Safety & Pharmacovigilance …

Continue Reading →
Coronavirus and Contact Tracing Apps
Volume 12 Issue 4

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 public debate is to …

Continue Reading →
The Global Regulatory Landscape for Clinical
Volume 12 Issue 4

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 experienced challenging conditions in managing …

Continue Reading →
To Participate or Not Participate
Volume 12 Issue 4

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 research planning process as it …

Continue Reading →
Clinical Evaluation and Post-marketing
Volume 12 Issue 4

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 andassumes a pivotal job in …

Continue Reading →
The Immense Potential of Africa’s
Volume 12 Issue 4

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 barriers, misunderstandings of requirements to …

Continue Reading →