As the clinical supply industry evolves, so does its vernacular. Small molecules are making way for large ones, resulting in genetic therapies. We no longer work in ambient conditions; today, controlled room temperature best describes the handling process. Even the term sponsor company itself evolved from the fact that companies other than R&D pharmaceuticals are running trials.
These are unprecedented times in our industry. The immediate need for COVID-19 treatment and vaccine has created a clinical trials scenario that would’ve been unthinkable just six months ago. Vaccine development typically takes 10-15 years. Yet reports indicate that it took about eight weeks from first receiving the Coronavirus in labs to the first dosing of a test vaccine. Nearly every pharma company examined their commercial and clinical lines to find treatment potential that could help provide relief for the growing number of COVID patients. Now the world eagerly awaits news for effective treatments and ideally a vaccine.
The role of clinical supply is a very crucial link in the supply chain, yet one that is often glossed over by other groups along that chain. Many decisions are made upstream that have direct impacts on what can be done once a project is handed off to you and your team, without much consideration to the impact it has on the management of trials as it relates to dosing, formulation, delays, vendor selection, and perhaps most critically… milestones.
The clinical trial landscape is changing. Historically, smaller pharmaceutical companies focused on preliminary research, which they sold to larger pharmaceutical companies that sponsored Phase 2 and Phase 3 trials.
Last year, Xerimis upgraded to ZenQMS, a cloud-based quality management system. For all of its benefits, cloud-based technology is still surprisingly rare among quality systems in clinical trial packaging. As such, next-generation ZenQMS has been well received by a population we work with all the time, and that’s critical to successful outcomes: our clients’ auditors.
There is a “super sizing” trend in the clinical supply industry as larger vendors continue to acquire their smaller competitors. In the last year alone, there were seven acquisitions that occurred between vendors.