The role of a Qualified Person (QP) in pharmaceutical manufacture was introduced to European law almost 50 years ago. As new technologies, globalization, and even politics have changed the clinical landscape over time, QP responsibilities and legislation have evolved. Two recent changes, and what they mean for clinical trial sponsors, are summarized here.
We’re thrilled to be working alongside Area Europe, a UK-based construction firm specializing in workplaces, on the design and fit-out of our environmentally sustainable facility in the Netherlands. The 45,000-square-foot site marks the new location for our next global depot, enabling us to increase operations in alignment with the growing needs of our clients.
Clinical trials have traditionally revolved around specific clinical sites where study participants visit and the bulk of trial activities take place. Designed to increase patient convenience and bolster the enrollment process, decentralized clinical trials (DCTs) use a virtual-first approach to bring the study to patients, wherever they are.
As we enter our 20th year in business, Xerimis is proud to announce major expansion at our US headquarters as well as expansion in Europe. These efforts will increase our storage and service capabilities, while enabling us to stay focused on our core values of quality, flexibility, reliability, and responsiveness.
It started with business plans that took a surprising turn in order to serve a highly specialized industry. Here’s a brief look at the history of Xerimis, what makes us unique, and how we’ve evolved over the years.
Clinical trials are full of unknowns. Trials hinge on detailed planning in countless areas under the clinical supply management (CSM) umbrella: sourcing and procurement, temperature monitoring, logistics management, supplies forecasting, import regulations, and more. Given the potential for supply chain unknowns to delay or derail studies, sponsor companies—particularly those new to the clinical trial scene—can benefit from outsourcing its CSM to experts.
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” 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 management of trials in relation 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.
On Saturday, March 21st, the Governor of New Jersey issued an Executive Order No. 107 requiring all Non-Essential Retail Businesses to close. Xerimis is not forced to close our business since Xerimis is part of the pharmaceutical supply chain responsible for providing medicines to patients, and as such is considered in the category defined as Healthcare/Life Sustaining businesses.
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: our clients’ auditors.