Multiple Site Management Strategies – Amy Henderson Featured in Q&A with International Clinical Trials
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
Paradigm Clinical Research Expands into Modesto, Increasing Clinical Trial Opportunities in California’s Critically Underserved Central Valley Corridor
Paradigm Clinical Research announces the opening of its newest clinical research site in Modesto, California. This expansion aligns with our mission to serve communities historically underrepresented in clinical trials. The Modesto clinic represents another example of Paradigm Clinical Research’s operating playbook and de novo expansion strategy. Modesto represents a strategic addition to our footprint, aiming to provide access to clinical trials across the Central Valley region. Our decision to establish a presence in Modesto was driven by the area’s demographic diversity and profound lack of any other professionally managed clinical trial businesses. Our goal in Modesto is to create a robust clinical research ecosystem that supports both study sponsors and the local community. The expansion in Modesto complements Paradigm Clinical Research’s long standing clinic further north in Redding, CA and the company’s strategic interests in the intermediate markets including Sacramento and beyond. This development follows our successful clinic openings in Boise, Idaho, and our flagship site in San Diego. It underscores our mission to provide opportunities to advance the human condition through participation in clinical research.
Paradigm Clinical Research Opens Its Flagship Clinic in San Diego, Marking 15 Years of Success
Paradigm Clinical Research, a leading clinical research site business, announced the opening of its flagship clinic in San Diego, California coinciding with the celebration of the company’s 15th anniversary. This is a significant milestone in the company’s growth strategy, positioning its flagship site to better serve the evolving needs of patients and the clinical research community. “The opening of our flagship clinic solidifies Paradigm Clinical Research’s position at the forefront of the multi-location and multi-specialty clinical research site market,” said Kurt Mussina, CEO of Paradigm Clinical Research. “Our operating model is ‘one site offering many locations and investigators,’ meaning all our clinics and staff function under a single, harmonized set of operating standards and principles. This positions us well to deliver industry-leading value to all stakeholders, especially patients, as evidenced by our exceptional patient Net Promoter Score® of 96. The opening of our San Diego clinic not only aligns with a decade and a half of success, but also validates our unique operating and growth strategies.” “We are proud of the success the entire Paradigm Clinical Research team has achieved, including the opening of the company’s flagship clinic,” said Aleem Choudhry, Managing Partner at Crane Street Capital. “This highlights the strength of the team’s managerial and operational expertise, providing the company with an even greater ability to meet the needs of clinical trial sponsors on so many different levels.” Paradigm Clinical Research celebrates its 15th anniversary this year, marking a decade and a half of success supporting industry sponsored clinical trials. The company remains committed to fostering diversity and inclusion and boasts access to a distinguished team of principal investigators across several therapeutic areas and specialties. For more information about Paradigm Clinical Research and its services, please visit paradigm-research.com. About Paradigm Clinical Research Paradigm Clinical Research is a long-standing clinical research site business with locations in California, Colorado, and Idaho. The company operates wholly owned sites that support Phase I-IV clinical trials and provides sponsors with access to diverse and often under-represented patient populations and investigators. Paradigm’s mission is to enrich lives by offering opportunities to advance the human condition through participation in expertly conducted clinical trials. To learn more, please visit paradigm-research.com. About Crane Street Capital Group Crane Street Capital Group specializes in micro growth buyouts in a few selected fragmented industries with untapped white space potential for growth. Its investments target companies that not only have outsized growth potential within their industries but also have the ability to make tremendously positive impacts within the communities in which they operate. Crane Street maintains a concentrated portfolio, deploys capital on an independent basis when outstanding opportunities are available and implements a patient approach in value creation over typically 5+-year holding periods. Currently, there are seven companies in the portfolio, four of which are in education services and three of which are in healthcare services.
Paradigm Clinical Research Expands Into Boise, Idaho, Advancing the Company’s Portfolio of Therapeutic Area Expertise
Paradigm Clinical Research, a leading clinical research site business, announces the opening of its latest clinical research site in Boise, Idaho. February 8, 2024 – This marks a significant milestone as the company establishes its first site in Idaho, further advancing its footprint and its portfolio of therapeutic areas including women’s health studies. This emphasizes Paradigm Clinical Research’s commitment to making meaningful differences in the lives of the individuals and communities the company serves. The Boise site complements the company’s existing locations, reinforcing Paradigm Clinical Research’s dedication to establishing purpose-built research sites that cater to the growing demand for study participants and the crucial need for diverse populations and investigators. The expansion in Boise includes the company’s growing roster of partner investigators, including Dr. Keri Erland, Dr. Kelly Siudzinski, Dr. Tara Erbele, and Dr. Roger Wyatt, all playing pivotal roles in bringing clinical trial opportunities to the greater Treasure Valley community. Kurt Mussina, CEO of Paradigm Clinical Research, emphasized the unique aspect of this expansion, stating, “Boise represents more than a geographic extension for us; it’s an opportunity to make further strides in women’s health and our other therapeutic areas of interest. We are not merely opening a new location; we are expanding our commitment to advancing healthcare, particularly in areas that matter most to the community.”
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.
Paradigm Clinical Research Announces Expansion of Site Locations
Company Doubles Commitment in Denver Market with Additional Clinical Research Site REDDING, California; April 18, 2023 – Paradigm Clinical Research, a leading clinical research site business, announces the opening of its clinical research site in Littleton, Colorado, the company’s fourth location. The new site location complements the company’s long-standing site in Wheat Ridge, Colorado. This expansion is a continuation of Paradigm Clinical Research’s growth strategy, which focuses on creating purpose-built research sites to fulfill the industry’s demand for study participants and the critical need for diverse populations and investigators. As part of this strategy, the company has partnered with Andy Fine, M.D., who will serve as a principal investigator (PI) in Littleton. Dr. Fine is a primary care physician at Colorado Primary Health Care, which is the leading primary care group in the area, serving a large and diverse patient base. “We are thrilled to expand Paradigm Clinical Research’s reach in the Denver market and are excited about our partnership with Dr. Fine and other physician specialists in the area. Our mission is to provide the communities we serve with opportunities to advance the human condition through participation in expertly conducted clinical trials,” said Kurt Mussina, CEO of Paradigm Clinical Research. “I became a principal investigator because I want to be at the forefront of medical advancements that can have a positive impact on patients and help advance health care globally. That’s why I chose to partner with Paradigm Clinical Research — their commitment to honesty, integrity, and communication aligns with my values and ensures that we can conduct research in a way that benefits both our patients and the larger medical community,” said Dr. Fine. Paradigm Clinical Research is currently seeking additional principal investigators in Littleton and has a reception Wednesday, May 17, at 5:30 p.m. at Hotel Teatro for local physicians in the Denver area who are interested in supporting industry-sponsored clinical trials. To learn more about Paradigm Clinical Research or to inquire about becoming a principal investigator, please contact us.
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 Clinical Research 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