Establishing Efficiencies in Endocrine & Metabolic Clinical Trials
Endocrine and Metabolic diseases remain a growing area of focus for clinical research. This high demand for novel therapies faces challenges in patient recruitment and study efficiency. Metabolic studies demand rigorous attention to regulatory strategies and safety data to ensure the efficiency of your development program.
With a successful track record of approvable NDA submissions, deep therapeutic expertise and decades of experience, Medpace can successfully navigate the operational complexities and regulatory scrutiny that endocrine and metabolic development programs often face. We have experience in recruiting historically difficult and highly competitive patient populations, including patients with diabetes, narrow HbA1c inclusion ranges, or patients with variable lipid disorder or rare endocrine diseases like cushing’s or acromegaly.
Medpace Experience in Metabolic Diseases:
Obesity Expertise
With decades of phase I-IV metabolic experience and access to in-house and external data streams, Medpace supports the development and execution of rare to large global obesity trials. Medpace has medical, operations, and regulatory staff who understand the complexities of obesity trials from the perspective of the Sponsor, the patients, the clinical investigator, the scientific leader, and the reviewer at the regulatory agencies. Our matured relationships with global thought leaders, investigative sites, the Medpace global ‘flagship’ metabolic site network, and patient advocacy groups, as well as knowledge of effective patient retention strategies, ensure efficient and quality patient enrollment which is key to the success of these programs.
Success Stories in Diabetes Studies
The enrollment and retention of study participants is critical in ensuring a trial runs smoothly and without delay. But for many studies, especially those for common or widely spread diseases with many competing trials, recruitment and retention can present a significant challenge and pose a risk to delaying timelines, adding cost, and impacting probability of success.
The Medpace team implements strategies to overcome recruitment challenges and achieve enrollment timelines. Our relationship with Sponsors is always transparent and collaborative, which ultimately supports study success.
In a recent Phase II, Type 2 diabetes trial, Medpace faced aggressive timelines to meet a submission deadline. Through a multi-step approach, we were able to accelerate site selection and patient recruitment to help our Sponsor meet enrollment timelines.
Metabolic Dysfunction-Associated Steatohepatitis (MASH) Expertise
As a therapeutically-aligned CRO, Medpace has the relevant and recent hepatology experience in indications such as MASH and MASLD (formerly known as NASH/NAFLD) to successfully navigate the complexities and regulatory scrutiny often involved with these programs. Our experience, coupled with our strong relationships with KOLs and investigative sites and our in-house central lab and imaging core lab services, set you up for long term success.
The Medpace Advantage for Endocrine & Metabolic Clinical Trials
Leverage Medpace’s medical expertise, global regulatory knowledge, operational experience, and cross-functional, collaborative therapeutic teams to develop custom strategies that expedite study start-up times, keep patients engaged, bypass pitfalls, and accelerate the licensing of life-changing therapies.
CONTINUOUS GLUCOSE MONITORING:
Benefits and Challenges of cgm in Clinical Trials
Comprehensive Medical, Regulatory Affairs, and Operational Expertise
Medpace has built a team of therapeutically-aligned operations and regulatory experts who work collaboratively throughout a study to ensure high levels of quality and efficiency. Our world-class team of in-house medical directors provide strategic direction for study design that will allow us to reach quality endpoints, train operational staff, work with Investigators, provide medical monitoring, and meet with regulatory agencies. Our team of advanced nurse practitioners provide an additional layer of medical expertise and support with their unique patient and site perspectives to help streamline and optimize studies. Our medical experts are embedded throughout every study.
Operationally, Medpace has a proven track record of rapid study start-up, successful recruitment and retention, high quality site monitoring and oversight, and proactive risk mitigation. Our experts are trained to guide you through regulatory and competent authority approval processes to accelerate pathway approvals.
Imaging Core Lab
Benefit from our comprehensive imaging expertise to ensure that imaging components are seamlessly integrated into the clinical trial. We support imaging analysis for metabolic disorders such as diabetes, obesity, and metabolic dysfunction-associated steatohepatitis (formerly known as NASH). Our metabolic imaging endpoint measurements include hepatic fat fraction, and hepatic fibrosis.
You Benefit From:
- Board-certified radiologists and endocrinologists demonstrating extensive clinical trial experience with complex CT, MRI and DXA assessments (Bone Mineral Density and Total Body Composition)
- In-house, registered CT, MRI and DXA technologists who maintain widespread knowledge in qualifying sites with customized & advanced data and acquisition protocols
- Integrative team of technologists, physicians, and medical physicists collectively possess years of experience successfully conducting imaging studies, that utilize the CT, MRI and DXA modalities, and their respective analysis and quality control checks
- Imaging project managers that specialize in managing imaging trials utilizing these modalities, designing and testing novel phantoms specifically for hepatic fat fraction assessment in MR Imaging
Fact Sheet
Full-Service Imaging for Clinical Studies
Expert Cardiovascular Imaging Solutions
ECG Core Lab
Given the importance of assessing cardiovascular risk and cardiovascular monitoring in many endocrine and metabolic trials, Medpace ECG core lab provides yet another layer of integrated efficiency. We offer ECG acquisition and analysis services utilizing industry-standard devices and systems, allowing ECG results to be interpreted 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.
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 diabetes test menu includes HbA1c, fasting glucose and insulin, GH, IGF-1, TSH, and other biomarkers of insulin resistance (e.g. HOMA-IR and proinsulin/ insulin ratio) and importantly, our in-house experts can help you determine the best biomarkers, the right analytical method and best regulatory approach for your compound.
Fact Sheet
Comprehensive Central Laboratory Services
