Cutting-Edge Trial Design & Execution in Obesity
With decades of phase I-IV metabolic experience, Medpace is the leading global CRO for obesity clinical studies. Our seasoned medical, operational, and regulatory teams are embedded throughout your project and remain laser-focused on execution – providing unparalleled support for your trial. Extensive team experience, strong relationships with trial sites and key investigators augmented by advanced in-house and external data streams (Intellipace®) enable Medpace to effectively support the planning and successful delivery of rare to multi-trial mega programs.
Medpace Experience in Metabolic Diseases:
Our experienced staff understand the many nuances of obesity trials from the perspective of the Sponsor, the patients, the clinical investigator, the scientific leader, and the reviewer at the regulatory agencies. Through our matured relationships with global thought leaders, investigative sites, the Medpace global ‘flagship’ metabolic site network, and patient advocacy groups, including utilization of tried and tested patient retention strategies critical for obesity trials, we ensure efficient and quality patient enrollment which is key to the success of these programs.
Our comprehensive CRO services are supported by our fully integrated global central lab services, bioanalytical lab, imaging core lab, ECG core lab, and Phase I unit, as well as a single Clinical Trial Management System (ClinTrak) that ties all the study data together in a single platform. The built-in collaboration and efficiencies of working with a single vendor facilitates a streamlined model for executing obesity programs supporting speed and quality data while ensuring cost efficiencies.
Making the Complex Seamless® in Obesity Clinical Development
Cross-Functional Expertise in Obesity
Medpace has built a specialized team of medical, operations, and regulatory experts with a focus on obesity who work collaboratively to ensure high levels of quality and efficiency. Leading our team are world-class, in-house medical directors who provide strategic guidance for study design, train operational staff, collaborate with investigators, offer medical monitoring, and engage with regulatory agencies. Complementing their expertise, our team includes advanced nurse practitioners who provide an additional layer of medical expertise and support with their unique patient and site perspectives to help streamline and optimize obesity studies.
Optimized Site Selection
A data-driven, risk-assessed feasibility and recruitment strategy coupled with an expert, dedicated patient recruitment and retention team ensures expedited enrollment and reduced patient dropouts. Let our knowledge of the best obesity sites and relationships with key investigators position your study for efficiency.
Medpace’s IntelliPACE®️ model synthesizes data from internal and external data sources to guide the selection of the best countries and sites for study participation. Site selection is further enhanced by established relationships with individual sites and site networks. Key sites across the globe have earned the designation of a ‘Flagship Site’ and have a history of partnering with Medpace for timely, high-quality outcomes.
Expediting Enrollment & Improving Patient Retention
Study enrollment efforts are centralized and streamlined through our in-house patient recruitment and retention teams. Medpace works side-by-side to identify potential patients through database and chart reviews. We ensure that patients are supported throughout their clinical trial experience by focusing on education, comfort and convenience, and providing technology to support participation.
A well-known challenge in the clinical development of anti-obesity agents is the potential high drop-out rate, primarily attributed to three key reasons: perceived absence of effect in regard to weight loss, tolerability of study drug/study requirements, and access to alternative treatment options. Our experience and knowledge of key mitigation strategies to address these retention challenges in obesity trials enable us to reduce drop-outs to keep studies on track and ensure the highest quality of endpoints.
Medpace has developed processes and technology to support the collection and analysis of patient reported data in obesity trials through its TrialPACE® ePRO/eCOA/eDiary system. This easy-to-use, yet sophisticated tool can increase active subject participation in the research and contribute to improved patient retention.
ECG Core Laboratory
Obesity is a significant contributor to the development of cardiovascular risk factors such as dyslipidemia, type 2 diabetes, hypertension, and sleep disorders. Consequently, assessing cardiovascular risk and monitoring is crucial in many obesity trials. At Medpace, our ECG core lab adds another layer of integrated efficiency to support your research. Our services include ECG acquisition and analysis using industry-standard devices and systems, allowing for the interpretation of ECG results in the context of other data. Our in-house physicians and cardiology experts have excellent peer-to-peer relationships with KOLs, plus extensive global experience with trial design, data interpretation and analysis, global study management, and regulatory strategy consultation.
Medpace Imaging Core Lab also has extensive experience in running obesity trials with imaging such as DXA, which can provide important body composition data for study endpoints.
Integrated Central Laboratory
Medpace central laboratories have unparalleled experience and expertise in the development of diabetes, lipid and cardiovascular modifying therapies. Key staff include physicians, managers, and technologists with considerable expertise in central laboratory operations for the pharmaceutical industry and federally funded programs, from discovery and proof of concept through large, long term global trials. In fact, our central laboratory has conducted over 510 studies that have included over 385k subject screenings, 125k sites managed, and 13k validated assays in this area.
Our validated test menu includes over 45 obesity-related assays, including HbA1c, fasting glucose and insulin, GH, IGF-1, TSH, and other biomarkers of insulin resistance (e.g. HOMA-IR and proinsulin/ insulin ratio). Our in-house experts can help you determine the best biomarkers, the right analytical method and appropriate regulatory approach for your compound.
Hear from our Sponsors:
“Medpace is managing our Phase II Obesity study in a fully integrated manner. This has allowed them to successfully execute the study with the coordinated efforts from Project Managers, CRAs, Central Laboratories and ancillary supportive services. Their relationships with quality sites allow them to streamline the startup process and communicate successfully with Investigators and site staff throughout the conduct of the study.”
