The Qualities to Evaluate in Your Site Evaluation Representatives

Clinical Researcher—September 2021 (Volume 35, Issue 7) SITES & SPONSORS Elizabeth Weeks-Rowe, LVN, CCRA   With site evaluation visits, that adage about how “presentation is everything” rings true and applies to far more than the confirmation of the capabilities of a site’s facilities and equipment. It even extends beyond the training and experience of the […]

Streamlining Adoption of Digital Technology in Clinical Trials Through Use of Open-Source Algorithms

Clinical Researcher—September 2021 (Volume 35, Issue 7) PRESCRIPTIONS FOR BUSINESS Geoffrey Gill, MS   Clinical trials have become both increasingly expensive and less reliable as the focus of therapy development has shifted to managing chronic illnesses. Wearables and other digital technologies have the potential to transform clinical trials by allowing investigators to transition from using […]

Not Your Mother’s Quality Management System: A Next-Generation, End-to-End Automated QMS

Clinical Researcher—September 2021 (Volume 35, Issue 7) PEER REVIEWED Christina Morris; Erika Stevens, MA   Pharmaceutical companies face a number of challenges, including (but not limited to) an evolving regulatory landscape; increased focus on quality metrics by governing agencies; data integrity and governance misalignment; lack of understanding customer needs; difficulty reproducing prior results for inquiries […]

Is There Anybody Out There?

Clinical Researcher—September 2021 (Volume 35, Issue 7) OVER THE TRANSOM Gary W. Cramer   If memory serves me correctly, it was sometime in March 2020 that I was dragged, kicking and screaming, from my cubicle in the ACRP headquarters along the Potomac River in Alexandria, Va., and forced to work at home during the early […]

A Race Against Time: How COVID-19 Changed Drug Development

Clinical Researcher—September 2021 (Volume 35, Issue 7) TRIALS & TECHNOLOGY Gadi Saarony, MBA/MIM   March 18, 2020 marked the day the U.S. Food and Drug Administration (FDA) brought clinical research to a near stop, sending the life science industry into an existential crisis. Almost immediately, clinical trial organizers found themselves in a fight for survival, […]