Global Outcomes Studies
Driving meaningful evidence for regulatory and market success
Driving meaningful evidence for regulatory and market success
Advancing Outcomes Research
At Medpace, we recognize that outcomes studies are more than just clinical trials – they are essential for demonstrating real-world benefits, securing regulatory approvals, and supporting market access. Our global, full-service offering ensures that Sponsors generate the high-quality evidence needed to prove safety, efficacy, and long-term impact. Medpace helps Sponsors navigate the complexities of outcomes trials by leveraging our strong site knowledge and relationships, our global footprint of nearly 6,000 employees across 40+ countries, and our recent, relevant experience managing large cardiovascular outcomes trials. Our fully integrated approach ensures seamless study execution across all phases, with a focus on high-quality data collection, regulatory compliance, and efficient study timelines.
The Leading CRO in Cardiovascular Outcomes Trials
As regulatory agencies place increasing emphasis on long-term safety and efficacy, cardiovascular outcomes trials (CVOTs) have become critical for many therapies and required by regulatory bodies for marketing approval consideration. Through deep scientific, operational, and regulatory expertise and established global site and investigator relationships, Medpace is the leading CRO in executing pivotal CVOTs. Our cross-functional cardiovascular leadership team remain fully embedded throughout your program, and bring extensive experience managing global outcomes studies across thousands of sites and patients in conditions including, but not limited to, atherosclerotic cardiovascular disease, coronary artery disease, hypertension, metabolic dysfunction-associated steatohepatitis, type 2 diabetes, and obesity.
Medpace CVOT Experience (Last 5 Years)
Making the Complex Seamless® in Outcomes Research
Global Site Expertise
Medpace’s strong relationships with high-quality global sites coupled with our dedicated site engagement strategies accelerate site selection, expedite start-up, and secure site activations in line with projections. Our Site Relationship Coordinators (SRCs) serve as dedicated, long-term contacts for sites – fostering strong relationships that enhance study execution. Positioned strategically across the globe, SRCs provide country-specific, tailored site engagement in local languages to ensure clear communication and proactive support. Beyond traditional CRA roles, they expedite feasibility, assist with start-up, and resolve operational challenges.
Further streamline your study start-up through the Medpace Flagship Site Program – an established group of top performing global sites and site networks with a proven track record of delivering timely, quality outcomes. Aligning top-tier sites with Medpace’s rigorous standards ensures consistent support, rapid feasibility assessments, and efficient study start-up.
Watch Now: Keeping your Study on PACE with Medpace Risk Based Monitoring
Unlock the Power of Data
Outcomes studies require a technology solution that provides on-demand access to study data, delivering actionable insights to protect data integrity. ClinTrak® meets these needs by offering access to all your clinical study metrics in an intuitive interface – unlocking deeper insights and empowering objective, data-driven decision making. By unifying the latest metrics across various functions – including clinical operations, adjudication management, labs, imaging, ePRO, and IRT – into a single, intuitive platform, ClinTrak gives you a centralized view of your program, keeping you informed to make proactive, confident decisions at every stage of your trial.
Powered by advanced analytics, ClinTrak delivers insightful data visualizations to help you track trial progress, identify trends, and make data-driven decisions, all without the burden of time-consuming manual review. Our dedicated and specialized outcomes integrity unit remain embedded in your program to offer customized solutions tailored to your specific study needs that facilitate centralized operational oversight. ClinTrak Data Explorer allows for the oversight of a variety of activities including, but not limited to, study management, clinical monitoring, patient safety, risk assessment, clinical events, recruitment and retention to support the identification of real-time anomalies, creation of actionable triggers, mitigate risk, and escalate issues as necessary. It provides on-demand access for internal and external user oversight, empowering Sponsors to monitor key milestones and delivers quality outcomes on time and within budget.
Patient Recruitment & Retention
Once the optimal strategy is defined, our specialized patient recruitment and retention team steps in to execute the plan seamlessly and efficiently through our ExcelliPACE® process. This in-house team works alongside Sponsors to support recruitment and retention efforts, including customized site and patient engagement strategies and tactics that are focused on building interest and enthusiasm for the study, enrolling the necessary patient population, and then supporting staff members, patients, and caregivers to drive retention. From study branding to ensuring patient needs are planned for and met, our team is focused on achieving timelines and recruitment milestones.
Regulatory Intelligence
Medpace’s regulatory expertise ensures strategic planning and continuous compliance throughout outcomes studies. Our dedicated regulatory team leverages a robust intelligence database that is routinely reviewed to support critical study processes, including drafting regulatory documents with applicable Informed Consent Form (ICF) language and navigating country-specific requirements for vital status checks and medical record reviews. With deep regulatory knowledge across global regions, we proactively address challenges, streamline approvals, and maintain compliance, enabling efficient study execution and high-quality data collection.
Clinical Endpoint Adjudication Services
Medpace delivers fully integrated Clinical Endpoint Adjudication Services through our specialized Clinical Event Management group, ensuring accurate and consistent evaluation of clinical events in outcomes studies. We manage all aspects of CAC operations – including charter and site training tool development and CAC selection, contracting, training, and facilitation of meetings. A single point of contact streamlines communication for Sponsors, sites, and CAC members, while our team coordinates event package compilation in tandem with SAE processing. Standard and customized adjudication status reports provide clear, timely updates throughout the study.
