Author: XerWPAdmin

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.

While the decentralized approach isn’t new, recent advancements in technology and new digital tools have made DCTs more feasible to run. But it’s the COVID-19 crisis that expedited its adoption and hastened regulatory acceptance. When stay-at-home orders ground the world to a halt, there was no choice but to implement alternatives to site visits. As patients and physicians have embraced the convenience and effectiveness of telehealth, more pharma companies have embraced virtual solutions for clinical trials. At McKinsey’s 2020 Clinical Operations Roundtable, 89% of surveyed pharma and contract research organizations expected to run a trial with most activities conducted in participants’ homes, versus 48% surveyed in 2019 by Industry Standard Research¹. DCTs have been gaining ground, and experts agree they are here to stay, with or without a pandemic.

Benefits and challenges of decentralized clinical trials

Shedding the geographical constraints that limit a sponsor’s pool of suitable participants is among the top benefits of a DCT. According to the Center for Information and Study on Clinical Research Participation, 75% of those surveyed were willing to participate in relevant trials². Yet industry resources approximate that 70% of potential participants live more than two hours away from a research site, deterring many from enrollment. With trial activities taking place at participants’ homes or other convenient locations, a decentralized trial eliminates or reduces the travel burden, resulting in faster enrollment and a more diverse study population.

In addition, study data can be collected at a faster rate in a DCT than a traditional trial. Many options are available for capturing participant responses and metrics, such as having patients answer questions via smartphone, attend telehealth appointments, or wear a web-enabled health monitor. Sponsors may also gain more insights from participants when they can take their time and answer questions in the comfort of their own home. Ultimately this can lead to better outcomes for patients and sponsors.

For all their distinct advantages, DCTs do have unique challenges: Regulations vary between countries, and some countries are slower to accept DCTs than others; data protection and patient authentication need to be considered; supply tracking and patient data processing may require changes; integrating new technology can be complicated for patients, sites, and others concerned; building a compatible infrastructure for DCTs involves buy-in from multiple stakeholders, some of whom may be difficult to persuade; placing the patient at center of supply chain entails specialized logistics planning, especially for global studies or temperature-controlled products.

However, regulations, technology, people, and processes are adapting. Also, decentralized doesn’t necessarily mean “fully virtual” or “site-less.” Most DCTs are a hybrid of virtual and site-based elements. Different approaches can be designed for different drugs and various populations. And sponsors transitioning to more decentralized trials don’t need to make sweeping changes overnight (although many did during the pandemic), but can work on building their DCT capabilities and technologies on select trials. Nor must sponsors tackle supply chain logistics and regulations on their own. They can partner with a contract packaging organization (CPO) experienced in flexible, global distribution, including direct-to-patient (DtP) shipments.

How the right CPO can help your decentralized trial

A good CPO will create a seamless experience for all parties involved in the clinical trial, no matter how the study protocol is designed. As a global CPO, Xerimis has provided packaging, labeling, storage, and distribution of supplies for traditional and decentralized trials worldwide. We can support your DCT in the following ways:

• Adapt our processes to your decentralized approach
• Help you identify the right supply chain lanes for your decentralized trial
• Coordinate DtP shipments of clinical supplies anywhere in the world through qualified couriers
• Direct couriers on any in-transit handling requirements specific to your supplies
• Leverage our strategically located GMP warehouses and partner depots to ensure your supplies are always available for the demand of a decentralized trial
• Advise on regulations and provide import services where necessary
• Follow strict procedures to safeguard patient privacy and data integrity in all countries where we ship your supplies
• Use inventory control systems and IRT for tracking your supplies
• Offer solutions for returns and accountability of unused or expired trial product
• Make the same commitment to quality, flexibility, reliability, and responsiveness that we make for any trial we support

By removing common enrollment barriers and speeding up data collection, a decentralized approach to clinical trials is a big win for investigators, sponsors, research coordinators, participants, and the advancement of medicine overall. DCTs require different processes and technologies than traditional trials. An agile supply chain partner is also critical. Xerimis knows how to seamlessly orchestrate all the moving parts of DCT logistics. From packaging to safe and compliant distribution of supplies, we’re ready to help your DCT succeed.

¹ https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/no-place-like-home-stepping-up-the-decentralization-of-clinical-trials

² https://www.ciscrp.org/wp-content/uploads/2019/06/2017-CISCRP-Perceptions-and-Insights-Study-Perceptions-and-Knowledge.pdf

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.

Expansion at Headquarters

Xerimis has just completed two expansion projects at our global headquarters in Moorestown, New Jersey.

Steps away from our current facility, we acquired and fit out a new warehouse at 2 Executive Drive. The new building offers 21,000 square feet of space for housing Returns and Destruction activities.

In addition, we constructed our largest yet cold-storage units within our GMP facility, expanding our capacity for temperature-sensitive drug product. The new walk-in refrigerator can accommodate up to 200 pallets, while the new walk-in freezer can accommodate up to 40 pallets.

“As the industry expands its presence in new therapies that require cold chain management, we knew that we needed to increase our capabilities to align with the growing needs of our clients,” explains Jim LoCascio, Vice President, Global Business and Strategic Development.

“It was clear that we needed to add more refrigeration and freezer space, but our present building had no room to expand. The smartest solution was to send Returns and Destruction to a second facility, allowing us to quadruple our capacity for cold storage and packaging, while keeping our GMP packaging operations and logistics under one roof.”

New Facility Overseas

Xerimis recently secured space in the Netherlands (NL) for building our next global depot and growing our European-based team. Alongside our US and UK facilities, our NL depot will provide us with greater flexibility in serving clients whose studies are distributed on a worldwide scale. It will also better position us to meet changing industry requirements as the European Union advances its new Clinical Trial Regulation. The 45,000-square-foot warehouse is located near Amsterdam Airport Schiphol.

“These monumental additions come on the heels of several years of growth for our company, and we remain thankful for the journey that has brought us here,” adds LoCascio.

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.

How the Story Begins

After working 20 years in pharmaceutical R&D, Peter Bernardo, PhD, made the decision to open his own company. He and his wife, Loretta, who worked as an RN, established their first company, Simirex. Originally they planned to focus on the generic drug industry. (They coined Simirex from the phrase, “similar to Rx.”) However, a growing trend in outsourced clinical supply services caught Peter and Loretta’s attention.

Drug innovators were increasingly looking to contract their packaging and distribution for clinical trials. The couple reconsidered their original plan and decided to establish Simirex as a clinical packaging organization instead.

The company took off quickly, bringing on pharma, biotech, and research organizations as clients. During the company’s growth, Peter and Loretta successfully opened Simirex Europe in 1996.

Hello, Xerimis

Looking to fold clinical packaging into their business portfolio, mega-CRO Quintiles Transnational Corp. purchased the Simirex companies in 1998. Peter and Loretta’s desire to support pharmaceutical innovation continued, however, and so they founded Xerimis Inc. in 2001. Xerimis may be Simirex spelled backwards, but forward is the only direction this company has ever moved.

Since 2001, Xerimis has helped bridge the gap between drug development and clinical trial patients. We provide customized solutions for clinical packaging and global distribution. At the end of the day, we make it easier for clients to bring life-changing drugs to those who need them.

It’s not just the well-rounded operational capabilities that make Xerimis unique. It’s our Project Managers, knowledgeable in clinical trial procedures and regulations. It’s our experience in customizing solutions for all types of product. It’s our tradition of building relationships with clients that last many years. It’s our core values of quality, flexibility, reliability, and responsiveness. We understand the effort and investment that goes into developing a new drug, and we honor our role in each study we support.

The Same, But Different

Now led by Carol Sue Bernardo, daughter of Peter and Loretta, Xerimis continues to meet the ever-growing needs of clients with the same dedication as always. Our capabilities and expertise have adapted over the past 20 years in response to changes across the industry and global politics. We opened new facilities in the United Kingdom and in the Netherlands. We established a network of partner depots throughout the world, enabling us to reach patients on a truly global scale. We quadrupled our cold-storage capacity at headquarters, and we expanded into a second warehouse on the premises.

Clinical trials can fail if drug supply is unavailable, improperly packaged, or distributed incorrectly. Xerimis helps each client circumvent these pitfalls. No matter what size or phase of study, we’re equipped and motivated to keep it moving forward. Client success is our goal, same as always.

Thank You

As we mark our 20th year in business, we want to thank our team, our clients, and our vendors who have been with us since the beginning. Your support helped propel Xerimis to new heights as a global clinical packaging organization. You’ve played an integral role in our story, and we value each of you like extended members of our family. As the next decade unfolds for Xerimis, we look forward to our continued partnerships with you.

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.

To meet the need for CSM expertise, Xerimis proudly introduces APEX (Advanced Protocol Execution).

APEX provides comprehensive CSM services, ideally as early as the drug formulation stage, though APEX’s modularity allows it to enter the equation at any point in the trial. Much more than project management, APEX CSM proactively guides and oversees every aspect of sponsor-related clinical supply activity at both US and EU/ROW levels, from protocol design and maintenance to program setup and rollout.

Katy Ostertag-Johnson, APEX Director of CSM Services, gives an example of how APEX can benefit sponsors: “With APEX, a less experienced client won’t have to figure out how to import investigational medicinal product (IMP) into Russia or Brazil on the fly. We’ll anticipate that need, engage the sponsor company or their CRO partner early, ensure ample time to prepare, and see that the import happens on time and within regulation — because we’ve done it before.”

Which points to APEX’s critical differentiator: Experience.

Capitalizing on years of collective clinical supply experience, the APEX team identifies challenges early, then strategizes, plans, and manages accordingly. This includes being able to recommend qualified vendors and partners as needed. Take Interactive Response Technology (IRT) platforms, for example. On their own, smaller sponsor companies may have never screened this critical trial component, or even know where to find prospects. APEX, meanwhile, has already reviewed options that are verifiably easy to use and can be mapped to trial specifications and objectives. Label translation and cold shipping are two more examples of specialized services where APEX can guide clients.

“Our clients can’t be expected to manage a clinical trial from a supply perspective if they’ve never done it before,” says Ostertag-Johnson. “Nor should they try to, given the stakes. With APEX, you’re not just enlisting someone to help you manage the trial. You’re getting experience and foresight you could only get through years in the industry. In most cases, partnering with us ultimately frees up financial resources that might otherwise be spent educating project managers or remedying mistakes.”

Why use APEX over a CRO-appointed clinical manager?

While a CRO may offer clinical supply management, sponsor companies can gain more efficiencies in outsourcing CSM to a contract packaging organization (CPO). “From my experience in working on the client-side, having supply management sit at the CRO adds an unnecessary layer to an already complicated process,” says Ostertag-Johnson. “When you manage supply through a CPO like Xerimis, you’re able to streamline those conversations about CSM and share a two-way flow of information with your packaging and labeling partner. This shared understanding, especially if APEX is involved early in the planning stages of packaging and labeling, study start-up, etc., helps mitigate risk and increases the potential for a successful clinical trial.”

Whether working backward from the target date for dosing first patient, or supporting a trial already in progress, APEX embodies the expertise to build studies, forecast supplies, and above all, navigate the supply chain unknowns.

Learn more about APEX services here, or contact us for additional information.