Making the Complex Seamless® in Substance Use Disorder Clinical Development
Overcoming the challenges associated with substance use disorder studies requires you to partner with a global clinical research organization (CRO) that has the experience and relationships in place to get your study up and running efficiently and effectively.
Accelerate your next substance use disorder study with support from Medpace’s well-established site relationships, a multi-dimensional patient recruitment model, and experience navigating the complexities associated with regulations regarding controlled scheduled drugs. As a full-service and therapeutically-focused CRO, Medpace specializes in the design and conduct of global trials in neuroscience clinical research, including substance use disorders.
The Medpace Advantage
Position your substance use disorder study for success by leveraging our global footprint, strategic medical, regulatory, and operational leadership, and fully integrated Central Labs and Core Imaging services.
The Medpace Difference for Substance Use Disorder Studies
Partner with a global CRO with a cross-functional collaborative model to position your substance use disorder trial for success. The Medpace Neuroscience Team can support your clinical trials through:
- Experience overcoming the challenges associated with regulations regarding controlled scheduled drugs –including getting sites up and running from a regulatory perspective
- Global central laboratory with safety and biomarker analysis to support substance use disorder studies
- Cardiovascular Core Lab can fully quantify the cardiovascular effects in the treatment of patients with substance use disorders
- In-depth knowledge of screening tools and rating scales and experience providing oversight for rater services including subjective assessments, interrater reliability, and scale validation
Specialized Imaging for Neuroscience Clinical Research
Neuroimaging has played a key role in clarifying that substance-use disorders are associated with changes in brain structure, function, and neurochemistry. Brain imaging studies have provided information on drugs, neurobiological effects, helped explain the causes and mechanisms of vulnerability to drug abuse and yielded important insights into abusers’ subjective experiences and behaviors, including their struggles in recovery.
Medpace Imaging Core Lab provides an end-to-end suite of global imaging services, including consultation on imaging biomarker strategies, image acquisition protocols, image collection / archiving services, and image analysis across imaging modalities and therapeutic areas ensuring imaging components are seamlessly integrated into the complex structure of the overall trial.
Patient Retention and Recruitment
Recruiting patients for substance use disorders can be challenging because patients need to be willing to get help for their addiction. Retaining patients is also difficult because high dropout rates are associated with this patient population.
Medpace navigates the complex patient recruitment and retention challenges associated with substance use disorder trials by employing our multi-dimensional recruitment model. Our dedicated patient recruitment and retention teams develop and implement customized strategies that identify, recruit, and retain members of specific patient populations. Our broad neuroscience experience and relationships with Investigators and Key Opinion Leaders (KOLs) worldwide give sponsors access to best sites for each specific program.
Substance Use Disorder Study Experts
Medpace has medical, operational, regulatory, and imaging specialists with relevant and recent experience in managing and executing substance use disorder studies. Serving as therapeutic team leaders, our in-house neuroscience physicians apply years of psychiatric drug development experience and are embedded throughout every study, providing a greater depth of expertise and the ability to tackle the complex challenges often associated with substance use disorder trials. Our medical directors provide strategic direction for study design and planning, train operational staff, work with Investigators, provide medical monitoring, and meet with regulatory agencies as well as our global regulatory affairs experts to provide strategic guidance on the best pathways to accelerate approvals.
Key Substance Use Disorder Experience
Our physicians and staff are experienced in the following areas: