Why Multisite Research Matters White Paper
Discover insights from the new AMRC white paper highlighting how Multisite Clinical Research Corporations (MCRCs) deliver faster start-up, greater consistency, stronger workforce retention, and expanded patient access. Learn why scalable, purpose-built research models are redefining quality in clinical trials.
Amy Henderson on Multi-Site Strategy in International Q&A Feature
Leading Multi-Site Research: Maximizing Efficiency and Reducing Turnover International Clinical Trials, August 2024, pages 95-97. © Samedan Ltd Managing multiple clinical research sites can be challenging, but with the right strategies, it’s entirely achievable. Effective management is key to reducing turnover, streamlining operations, and ensuring smooth research progress across locations. Amy Henderson speaks with International Clinical Trials about how a multi-site research business maximizes efficiency by harnessing challenges as opportunities. Learn best practices for resource allocation, team unification, and technology integration. Discover actionable insights on reducing turnover, standardizing procedures, and creating a motivated, cohesive team. Read Article
San Diego NBC 7 Cytomegalovirus (CMV) Article
Cytomegalovirus (CMV) is making headlines, and it’s behind a majority of US birth defects. The virus spreads through fluids, making it a serious concern for expectant parents. As we uncover more about this alarming situation, it’s crucial to stay informed and take necessary precautions to protect ourselves and our loved ones. Watch or read more in San Diego NBC 7’s “‘It’s spread with fluids’: Little-known virus behind majority of US birth defects” article. Paradigm Clinical Research is currently enrolling participants for a CMV vaccine study. Submit a form to learn more by filling out our join a study form. Knowledge is power, and understanding the risks empowers us to make informed decisions. Let’s share this important article to raise awareness and support clinical research efforts to combat this health challenge. Together, we can strive for a safer and healthier future for generations to come. Because Better Medicines Matter More Than Ever.
Pediatric COVID-19 Vaccine Study
Help pursue longer lasting protection against COVID-19 While most children do not become seriously ill from COVID-19, some do and require hospitalization. Children can still infect others and may be at risk of developing MIS-C, a rare but life-threatening inflammatory condition related to COVID-19. As new variants and subtypes continue to emerge, approval of a bivalent vaccine for children that effectively targets both current and future variants will be key for protecting them against COVID-19. This study may be an option for infants and children who: A study team member will help determine if this study is right for your child based on all participation criteria. Parents/guardians may be reimbursed for expenses related to participants’ time in the study. Contact a study member to learn more!
Paradigm Clinical Research Featured in NBC 7 San Diego, CA
NBC 7 San Diego recently did a news report on an important issue that has been affecting infants and toddlers. RSV is the leading cuase of serious respiratory tract disease in children worldwide. We are now enrolling infants and toddlers in San Diego, CA for this clinical research trial. Watch the video here to learn more. You can also learn more and sign up on our website.
Paradigm Featured in Clinical Trial Supply and Logistics Magazine
Sites, ‘Smart Money’, and Standard Operating Procedures Kurt Mussina at Paradigm Clinical Research outlines the best practices involved when running multiple research sites, and how to ensure site expansions occur smoothly. ICT: When expanding the number of locations in a clinical research site business, what is needed to ensure efficacy in the supply chains and other logistics? Kurt Mussina: Depending on the types of studies and therapeutic areas in which they are active, sites will require a certain set of common supplies and consumables. These are typically readily available from a variety of sources. For equipment and supplies that are less common or unique to a particular study, it is best practice to have the sponsor acquire and provide these to the sites. Often, sponsors have greater purchasing power and influence than sites. White it is not common to use the term ‘supply chain’ to refer to the availability of volunteers who are eligible to participate in trials, this is a critically important consideration when expanding into new locations and new therapeutic areas. You cannot be successful managing a clinical research site if you can’t effectively access and recruit a sufficient population willing and eligible to join trials. Finally, it is also critical to consider the importance of diversity and inclusion of underrepresented populations in clinical trial participation. This applies not only to volunteers but also to study investigators and site staff. How important is collaboration with other businesses, such as private equity firms, when organizing site expansions? Among many options, private equity is a common source of funding when expanding any business, whether through de novo or acquisition strategies. It is important to discern how familiar the private equity firm, or indeed any funding source, is with the marketplace in which you compete. Some funding sources are considered ‘not smart’ (i.e., unfamiliar with your particular market). Other sources are considered ‘smart money’ or referred to as ‘strategic’. These sources can often be collaborators, customers, or vendors with common interests and motivations. Unless there are good strategic reasons to do otherwise, it is typically best for the business to self-fund an expansion – assuming, of course, it is in good financial condition to do so. Otherwise, strategic money can bring with it good value and certain advantages. What are some common pitfalls of managing a clinical research site business across multiple locations, and how can they be avoided? Sute businesses with multiple locations often manage the business in a way that appears from the outside as multiple businesses. This is especially true of site networks. This lack of integration fails to address many of the fundamental inefficiencies found in clinical research. For example, there are often separate clinical trial agreements and budgets that must be negotiated and executed for each individual site. Indeed, in these cases, separate and distinct standard operating procedures are often in play/ Integrating the site’s operations and centralising common services, such as accounting and business development, is one way to avoid this. Put another way, an operating model that regards the business as one large site with many locations delivers the strongest value to all stakeholders. How might offering trials across multiple therapeutic areas impact the patient experience? Study protocols often, if not always, exclude people already enrolled in another study. However, sites that participate in studies across multiple therapeutic areas can provide more options to people interested in participating. So, if someone turns out to be ineligible for a certain study, they could still meet the criteria for another study – having options can only be a good thing. In addition, deciding which therapeutic area to compete in is strategically important for the site. Disease areas and indications that are adjoining can provide a competitive advantage. A good place to start is by considering the complications that often arise with a particular medical condition. For example, nephrology, endocrinology, and cardiology are specialties that can overlap for certain patients. What are some good practices when coordinating research teams across sites, including internationally? Full operation integration is key. So is strong site leadership and a properly-aligned organizational structure. Site leadership with good people skills is necessary. Combine that with good business acumen, and now you have a great recipe for success at that sire. Site leaders must appreciate that they are managing a business jsut as much as they might be managing studies. That requires an understanding of how the business operates, how value flows and how to measure financial performance. Beyond this, good, clear, and frequent communication is critical. The sharing of best practices and troubleshooting across sites, especially regarding enrolment challenges, can mean the difference between delivering outstanding value and mediocrity. Read the full conversation with Kurt Mussina, CEO of Paradigm Clinical Research and Clinical Trial Supply and Logistics
Paradigm Clinical Research Featured in Fox 5 News La Mesa, CA
La Mesa clinic conducting vaccine trials against RSV LA MESA, Calif. — A local La Mesa clinic is looking for patients to test vaccine trials for RSV. Researchers are hoping these vaccine trials can help combat the so-called “tripledemic” that many health officials are warning about. Researchers are looking for more patients to take part in this study. Jamie Williams of Paradigm Clinical Research showed FOX 5 kits they use to track antibodies in patients against respiratory syncytial virus or RSV. “The idea is that the subjects get one vaccine and they’re protected against RSV, so we follow them both for safety and to see if they develop RSV throughout the season,” said Williams. She is helping conduct clinic trials of an mRNA vaccine to protect against RSV in the elderly population. “What that means is there’s no live virus in the vaccine,” said Jamie. “We give that vaccine like a message and that tells your body to develop antibodies, which our immune systems build to fight infection.” The study comes at a time when respiratory virus cases are rising across the county. Health officials are warning of a “tripledemic” surge of cases of flu, COVID-19 and RSV. “The numbers are really high right now and there is research saying that our bodies are actually capable of carrying more than one virus at a time,” says Williams. County health officials say they don’t have a role in clinical trials, but released its latest respiratory virus report. It reported nearly 90,000 COVID-19 cases and more than 3700 flu cases in the county. “Having those cases helps bring awareness of how serious RSV can be. We’re trying to get subjects vaccinated before those cases really get out of control,” says Williams. Paradigm Clinical Research says it is still looking for hundreds of patients in the San Diego and La mesa area to participate. They say each patient will receive compensation per visit. Read the full article by Fox 5
Paradigm Clinical Research Featured in KRCR News Redding, CA
Redding-based clinical research center helps combat flu, RSV and COVID-19 by Mike Mangas, Adam Robinson – Monday, October 31st 2022 REDDING, Calif. — A Redding-based clinical research center is helping combat communicable diseases like COVID-19, RSV, and the flu to name just a few. Paradigm Clinical Research was started in Redding in 2009 and now has sites in the San Diego and Denver, Colo. areas, with plans to expand to three more locations in the next year. They enroll volunteers to research the effectiveness of vaccines. “They either receive an RSV vaccine or a placebo. They don’t know; we don’t know. It’s bonded data. Essentially, we draw their blood, we send it to a central lab, and they’re checking antibodies to check to see if the vaccine is efficacious. And we don’t get data of that until after the study ends,” said Sarah Sandberg, the center’s site manager. Volunteers do it for different reasons; there’s a small stipend. But, for someone like registered nurse Dawn Smith, it’s because she’s seen patients die unnecessarily. “I am an RN, and I have observed, participated [in], and witnessed patients who have not been able to, or not educated to, have immunizations. And that gap has caused dire consequences in our community,” Dawn told Mike during an interview on Monday. “I get [that] it’s for the research purposes. Not only does it further the research [on] the last vaccine, which was for COVID-19—that was Moderna. It’s helped out a lot; got the vaccine out to people a lot quicker. And, also, there’s the money factor. It helps out having a little extra money in your pocket,” said Mike Woodward, another research volunteer. Although they have a healthy database, Paradigm is always looking for more volunteers on any number of research projects. “We’re currently doing a flu vaccine study. It’s an mRNA-based flu vaccine for Pfizer. The placebo is the marketed flu vaccine. And that’s 18 and older. We just started enrolling for the full age group today,” Clinical Research Coordinator Emily Crews. Read the full article by KRCR