Ensuring Real-world Representation in Clinical Trials
In planning. In strategy. In recruitment. In every aspect of inclusive research, we’re all in.
Many patient populations are underrepresented in clinical trials, impacting the scientific integrity and generalizability of study results. The path to approval can be complex, and ensuring that clinical trial data accurately represents affected patient populations is crucial for creating therapies that are safe and effective for everyone. That’s why you need a partner that proactively drives strategies and solutions that strengthen the scientific validity and general applicability of research data, ultimately improving health outcomes.
Population science solutions
Our comprehensive offerings embed inclusive research solutions curated to meet your needs at every phase of drug development— early phase through post-authorization. Through proactive planning, innovative strategies and solutions, and unparalleled partnerships, you can be confident your trial will meet scientific and regulatory expectations for including clinically relevant patient populations, on time and on budget.
Regulatory and ethical considerations for ensuring clinically relevant trial populations
A dedicated team with an all-in commitment
When you partner with us, you are connected to a dedicated team trained specifically in population science and inclusive clinical research. Our subject matter experts combine their knowledge of global population health, cultural competency, tailored patient engagement, and industry trends with strategic consultancy. We optimize your trial design and startup for inclusion, leveraging our expertise to recruit and retain the patient populations that are right for your product.
Collaboration is vital to success. Population science strategies and solutions require an integrated, cross-functional team effort comprised of leading experts across our organization. We work with you to ensure appropriate real-world representation – considering your demographic recruitment goals, a comprehensive therapeutic epidemiologic review, and the regulatory standards in different areas of the world.
Here are some of the ways we support your clinical research needs
Study design optimized to include clinically relevant populations
- Epidemiology and disparity assessments
- Inclusive study design recommendations
- Development and operationalization of representative recruitment plans
Diversity-ready sites
- SiteCoach training
- Data-driven strategic feasibility
- Training and supporting sites on demographic recruitment plans
- Culturally and linguistically relevant site- and patient-facing materials
- Decentralized trial and digital tools
Ongoing population science counsel
Your dedicated population science strategist will keep you informed of any changing global regulatory guidance, as well as site and community updates — giving you the agility needed to stay ahead.
Leverage innovative technologies to facilitate greater inclusion
We meet patients where they are
For decades, logistical issues have been barriers to inclusive participation. Our robust decentralized clinical trial (DCT) solutions ecosystem utilizes technology and support services to make trial participation easier and less burdensome while improving retention and engagement.
Reach further
Increase study representation and improve experience and engagement through our digital and decentralized clinical trial solutions.
Reduce patient burden
Our geographic reach reduces patient burden with at-home care and less reliance on sites.
Remove barriers to participation
We leverage cutting-edge tools and advances in wearables, telemedicine and digital diaries to deliver new outcomes and faster data entry.
Connections with purpose
From participating in industry-wide initiatives to collaborating with national and grassroots organizations, doing more to broaden participation in clinical trials is our driving purpose. We cultivate industry collaborations and partnerships with community-based organizations that develop, maintain, and sustain meaningful, long-lasting relationships – bringing you closer to the communities you seek to serve.
Furthermore, we recognize that sites are often the “face” of your trial. That’s why we actively identify high-performing site networks with investigators who are already serving low access populations – delivering an inclusive experience to all patients that is second to none.
An inclusive mindset complemented by comprehensive population science services
Our early planning efforts and strategic guidance are amplified by a robust suite of services designed to:
- Center on the right patient demographics, the right sites and the right innovation to overcome barriers to participation
- Ensure the data gleaned accurately aligns with the patients intended for your product
Decisions guided by data
Want to better define strategies that optimize feasibility and study design? Our data dashboard unlocks insights at a granular level, better defining strategies to enroll clinically relevant patient populations at the site and community level.
- Truecast and TriNetX data provide an evidence-based strategy to target the right sites and patient populations.
- Our proprietary mapping tool overlays sites on regions of the U.S. using census data to show the non-white race/ethnicity that is most prevalent in every zip code.
- We provide study teams with comprehensive epidemiology assessments, supplemented with our team’s experience in public health research.
Optimizing sites that are embedded in communities
To better support our clients and meet study demographic goals, we established a patient diversity site alliance of more than 80 qualified community-based research sites. These sites, ranging from frontier to highly experienced sites, organically serve varied patient communities. All the sites are dedicated to fostering trust through authentic local engagement to support our customer trials and adeptly address common challenges in recruiting, engaging, and retaining specific patient populations. Through our alliance, we aim to accelerate the development of treatments that benefit everyone and increase access to cutting-edge health care solutions.
New sites? No worries. SiteCoach, our proprietary training program, trains and supports research-naïve sites to conduct successful clinical trials, access untapped patient populations and bring clinical trials to the community.
An inclusive environment increases engagement
Reaching low access patient populations can be challenging; engaging them throughout the clinical trial journey goes a step beyond. We support patients at every step of their journey with services like a clinical trial hotline, screening and referral services, patient concierge, reimbursement strategies and more. Taking time off from work deterring them? Need home health care services? We actively work to resolve patient barriers to enable more people to participate and stay engaged throughout their clinical trial.
When it comes to inclusive research, we’re all in. Are you?
Schedule a meeting to discuss real-world patient representation for your clinical trial.