ACRO in ACTION: Insights from the COVID-era

Ironically, the Pfizer-BioNTech Covid-19 vaccine program did not take “Operation Warp Speed” funding. Even more ironic is the fact that Pfizer got there first. For a global public eagerly awaiting approved products, all that really matters is that it…

It was a familiar scenario: A rare disease area of oncology. A new drug candidate. A desire to assess efficacy as safely and quickly as possible, so that if successful, a new therapy could get approved and change lives….

For the clinical research industry, technological tools improve trial continuity, and generate data that helps power more robust monitoring of safety and quality. They can also be a natural fit for patients. IQVIA also sees study participants liking the…

Diverse technology solutions, like patient telehealth visits, accessing electronic medical records (EMRs) or remote source data verification, can generate vast amounts of data. As the clinical research industry evolves towards its next “new normal” with a higher baseline level…

We all had a flurry of unprecedented activity. We were assessing risks to patients and data, and putting in place mitigation strategies to preserve continuity of the studies.” Those strategies involved thousands of amendments to protocols, adapting to sudden…

A key pillar in the COVID-19 battle is the rapid development of a safe and effective vaccine. As vaccine R&D shifted into gear and then accelerated throughout 2020, with a rapidly growing number of candidates, platforms and manufacturers, it…

In the 10 weeks following the US’ declaration of a pandemic crisis, hospital ER visits declined for conditions like heart attacks and strokes. Simultaneously, based on clinical trials in the Medidata ecosystem, new subject enrollment declined 30%. But also…

“There’s a global sense of urgency,” says Jamie Macdonald, CEO of Parexel, of the collaboration between stakeholders to accelerate development. One key focus for Macdonald is the lengthy process of trials, and compressing that “dead space” to shorten timelines,…

“The pandemic has changed everything about the pace of our innovation and our focus,” says Peyton Howell, EVP and Chief Commercial & Strategy Officer at Parexel. There used to be lots of caution around using real-world data and evidence,…

For Dr. Sy Pretorius, Parexel’s Chief Medical & Scientific Officer, COVID-19 has been a catalyst. The pandemic has accelerated innovations that make it easier for patients to participate and for sponsors to conduct research. Parexel has seen increases in…

New medicines are at the core of clinical research. Historically in clinical research, these experimental medicines move from a warehouse to a clinical research site, where they are administered to a study participant. But what happens when a pandemic…

In August 2020, Syneos Health CEO Alistair Macdonald reflected on the COVID-19 crisis to date. Read Part 1 of the conversation. In Part 2, we look at patient engagement and the conduct of clinical research, shifting the conduct of…