Current Edition

Volume 14 Issue 1

Cell And Gene Start-Ups Need “CDMO 2.0”

Louis Garguilo interviews Massimo Dominici, a professional of eminent status in the CGT field and founder of Rigenerand, about CDMOs. Over the years, Dominici and Mar...
Continue Reading →
Volume 14 Issue 1

Advancing Data from the Real World – Novel Approaches to Clinical Studies

Technologies that gather and store health-related data are generating real-world data (RWD) and real-world evidence (RWE) that are increasingly being applied in healt...
Continue Reading →
Volume 14 Issue 1

Key Clinical Trial Considerations for the New Normal and the Future

A great many new and varied approaches to clinical trial management are being adopted during the COVID-19 pandemic through the help of virtualisation tools, strong pa...
Continue Reading →
Volume 14 Issue 1

Operating a Clinical Trial in the Cloud:

The Fundamental Aspects of Creating an Agile, Scalable and Flexible Solution Capable of Delivering Better Results than Previous Study Models Bogged down by recruitin...
Continue Reading →
Volume 14 Issue 1

How a Defined Informatics Entity is the Key to Bridging Pharma’s Data Divide

When the health authorities began placing further emphasis on medicinal product data standards, the overlap between regulatory operations and systems beyond the regul...
Continue Reading →
Volume 14 Issue 1

Simplifying the Process of Managing Complex Country-by-Country Regulations in Clinical Trials

Clinical trials themselves have their own complications. Regulatory compliance and safety reporting are of the utmost importance in managing clinical trials. When you...
Continue Reading →
Volume 14 Issue 1

Optimising Early Clinical Development Strategies in Oncology

According to the largest analysis of almost 7,500 clinical and regulatory phase transitions, the likelihood of an oncology drug progressing from Phase I clinical test...
Continue Reading →
Volume 14 Issue 1

The Biotech Revolution: The Manufacturing & Quality Implications of Cell and Gene Therapies

The market for Advanced Therapies has come a long way in the last decade, to the point that some cell and gene therapies have already been approved, and others have n...
Continue Reading →
Volume 14 Issue 1

Using Machine Learning to Identify At-Risk Sites in Acute Schizophrenia Clinical Trials

Data quality concerns are frequent in schizophrenia clinical trials, causing many to suffer from drug placebo separation. Machine learning offers the opportunity to p...
Continue Reading →
Volume 14 Issue 1

AI/ML to Generate Medical Insights… While Maintaining Patient Data Security and Privacy

Machine Learning (ML) and Artificial Intelligence (AI) have come to the forefront of data analytics with the promise of generating new medical insights. However, for ...
Continue Reading →