Pharmaceutical Clinical Trials
Pharmaceutical Clinical Trials are regulated research studies conducted by pharmaceutical companies, biotech firms, or research organizations to evaluate the safety, efficacy, dosage, and side effects of new drugs, therapies, vaccines, or medical treatments in human participants. These trials follow phased protocols and regulatory standards to support medical approvals and evidence-based healthcare innovation.

The New Era of Representative Science: Operationalizing Diversity in Clinical Research
The pharmaceutical industry marks a definitive transition from an era of generalized medicine to the age of precision health. As the industry matures, the definition of clinical excellence shifts to demonstrate that a therapeutic asset is safe and efficacious for whom.
Pharmaceutical Trials Depend on What Happens at the Site Level
Pharma companies have also become incredibly picky about the sites they work with. A few years ago, the entire focus of the site meeting was site access and enrollment. Nowadays, the sponsor is critically evaluating the quality of the execution. They are looking for partners that can move fast but will not cause major operational headaches downstream, produce clean data, engage patients, and identify protocol issues before timelines have begun to slip.

Maribelle Guloy is the Director of Clinical Development at American Regent, a company of Daiichi Sankyo. Before joining American Regent, Dr. Guloy held various full-time and consulting roles at CROs, pharmaceutical, and biotech companies, including Moderna.
