Thank you to our team and our vendors

As we continue to monitor the COVID-19 virus and its impacts, I wanted to take a moment to extend a thank you to our team and our vendors. The past weeks have been challenging for everyone around the world, but amidst those challenges, we’ve truly seen the best in all of us and what we’re all capable of together.

To our team, your commitment to our work has been an inspiration. You’ve modified processes and taken time away from family to ensure that critical trials continue to happen. You know the importance of the work we’re doing, and you know the impact it can have on the entire world.

To our vendors, none of this would be possible without the critical role you play in the supply chain. Cartons and bottles are being produced, temperature-controlled shipments maintained, and courier services are delivering. You each play an essential role in the clinical trial process, and we thank you.

We know that the future will bring its own challenges, but I feel optimistic having seen what we’ve been able to achieve over these past weeks. Thank you for dedication and hard work, and commitment to making a difference.

Carol Sue Bernardo
Chief Executive Officer and Managing Director

COVID-19 Update: Vital Operations Continue at Xerimis

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.

The ongoing efforts to contain the spread of the COVID-19 virus throughout the world make this a very dynamic time for individuals and businesses alike. Xerimis continues our commitment to the safety of our clients, patients, and team members. We have transitioned many Xerimis employees to remote working to the greatest extent possible. We continue with our on-site activities including receiving, packaging, distribution and returns accountability and have implemented aggressive cleaning procedures for all areas of the building.  Our staff is already cross trained which will allow us to perform the most critical activities at Xerimis.

We are working collaboratively with all clients to ensure supplies are packaged and dispatched as planned.  We recognize the impact of COVID-19 and the new challenges that are being presented to sponsors.  We are actively working with our partner couriers to set up direct to patient delivery when this option becomes necessary due to circumstances related to COVID-19. We will work with clients to ensure we prioritize the most critical needs for patients.

We have begun seeing countries impacted by the COVID-19 virus and shipping lanes being impacted. We continue to keep our clients updated regularly and look for alternatives as needed. The likelihood of disruption to other geographical areas cannot be ruled out with each passing day. We are committed to our partnership with you and to being here to support you and patients in this most serious time for our world.

Carol Sue Bernardo
CEO

Xerimis Coronavirus Planning Measures

Xerimis is committed to the safety of our clients, patients, and own team members while we continue to ensure that your clinical supplies are packaged, dispatched and delivered with minimal disruption.

Xerimis operates under GMPs and as such we have existing policies and procedures in place for ensuring clean environments, proper hygiene by all employees and have a written plan in place should a pandemic crisis occur. In addition, we are also following recommendations provided to the public by the Centers for Disease Control (CDC) regarding the coronavirus.

Xerimis will continue to monitor communications and statements from our approved couriers that may impact their services in specific geographic locations. In turn, we will directly notify our clients of any potential impact to their shipping lanes or if any shipment request is unable to be completed due to government-imposed travel restrictions. Currently there are no restrictions on shipments within the United States and Canada. Globally, there are restrictions to specific geographical areas within countries such as China, Italy, Iran and South Korea; however, there has been no impact to ongoing shipments from Xerimis locations to date. The likelihood of disruption to other geographical areas cannot be ruled out only passenger travel is more likely to be impacted than the approved couriers we use. This is a dynamic situation and as such the information or restriction may be subject to change without notice. Xerimis will endeavor to ensure clients that may be impacted by such restrictions are notified as early as possible.

How Auditors Benefit From Our Cloud-Based Quality System

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.

Auditors have grown accustomed to electronic setups that require them onsite, at a company’s computer, to access the documents necessary to perform a Good Manufacturing Practices (GMP) audit. Sometimes a company representative is appointed to supervise this process, standing in the room, or even helming the computer, ensuring the auditor accesses only the information needed. With Xerimis and ZenQMS, auditors are given much more autonomy via a secure, customizable portal. They can access their password-protected account from any browser, anywhere in the world. This translates to less time onsite at our facilities, system access free of a company liaison, and freedom from the hassle of downloading software or procuring a software-enabled device.

To further improve the user experience, Xerimis offers auditors a customized navigation guide, letting them easily locate the documents they’re looking for once they’re logged in.

Auditors’ goals are clear and critical: To perform a mandated Good Manufacturing Practices audit of Xerimis before a client or prospective client can entrust us with new or reoccurring work.

When an audit is free of logistical challenges, all parties win. With ZenQMS, Xerimis audits are uniquely efficient, offering an easier process for everyone involved.