Making the Complex Seamless® in Sleep Disorder Clinical Development
Despite a substantial improvement in the understanding of sleep disorders in the last decade, there are still challenges in clinical development. Improved outcomes for patients with sleep disorders require a multifaceted approach. Developing effective treatments for sleep disorders requires a clinical research organization (CRO) partner with specialized expertise and relevant experience to effectively address the unique challenges involved.
Streamline and accelerate your clinical research in sleep disorders with support from our experienced, cross-functional team of medical and regulatory experts, clinical trial management teams, and integrated services. Our experience with global regulatory authorities, coupled with early planning and collaboration with Sponsors, accelerates the path to approval.
The Medpace Advantage
As a full-service and therapeutically-focused CRO with a unique approach to clinical development, Medpace specializes in the design and conduct of clinical trials in sleep disorders. Gain a competitive advantage for your program through our global footprint and strategic leadership teams dedicated to accelerating your sleep study.
Sleep Disorder Clinical Research Capabilities
Position your sleep trial for success by partnering with Medpace, a global CRO with a cross-functional collaborative model that can support your clinical trials through:
In-depth knowledge of screening tools and rater scales and experience providing oversight for rater services including subjective assessments, inter-rater reliability, and scale validation
Broad neuroscience experience and long-term relationships with experienced sites, networks, and key opinion leaders (KOLs) worldwide, providing access to the best sites for your specific program
A proprietary feasibility strategy and dedicated in-house recruitment and retention team to deliver custom-tailored recruitment strategies to support the unique needs of each sleep disorder trial
Placebo mitigation strategies to limit the potential for placebo response through site and participant education
Participant and site training on best practices for collection of participant reported data
Detailed knowledge of regulatory requirements for managing studies utilizing controlled substances, including DEA Schedule I investigational products
Patient-Centric Study Design
Sleep disorders often lead to daily challenges for patients, including excessive daytime sleepiness and deficits in alertness and attention. Understanding an individual participant’s needs in a clinical trial is critical. Medpace places participants at the center of a trial to increase awareness and reach enrollment goals while helping yield successful outcomes in terms of study design, participation, adherence, satisfaction, and data collection. Medpace Patient Concierge Services (PCS) provides global travel support to minimize participant burden, facilitate compliance with study visits, and help keep the study on track.
Streamline sleep clinical trials with a full-service, single-vendor outsourcing strategy. Our comprehensive CRO services are supported by our wholly-owned Central Laboratories, Bioanalytical Lab, Imaging and ECG Core Lab, and Phase I Unit, as well as a Clinical Trial Management System (ClinTrak®) that ties all study data together in a single platform. ClinTrak® provides IWRS/ IVRS, ePRO/eDiary, study management, data management, laboratory management, image management, and endpoint adjudication.
Endpoint Protection
Most sleep disorder studies are heavily reliant on patient-reported outcome (PRO) data as primary and key secondary endpoints. To successfully collect PRO data, consistent participant engagement is essential. To increase participant engagement in clinical research, Medpace has developed an ePRO/eDiary component directly within its ClinTrak® suite of systems. Medpace is experienced in providing robust site staff and participant training on proper PRO completion ensuring study endpoints are protected.
Specialized Wearable Capabilities for Your Sleep Disorder Programs
Actigraphy and other wearable biosensor technologies are useful tools in collecting estimates of wakefulness and sleep patterns over time. These tools provide objective measures of sleep data which can add important context to the subjective measures historically collected in sleep disorder clinical trials. All wearable biosensor technologies are selected and vetted by Medpace’s therapeutically aligned teams to meet tailored study design requirements, streamline vendor management, and accelerate study start-up. Medpace is able to seamlessly collect, harmonize, and integrate sleep data from actigraphy devices into your clinical trial.
Serving as therapeutic team leaders, our in-house medical doctors apply years of drug development experience to each study, providing greater depth of expertise and the ability to tackle complex and challenging diseases. Our medical leaders are at the center of your trials to provide strategic direction for study design and planning, train operational staff, work with Investigators, provide medical monitoring, and meet with regulatory agencies to provide strategic guidance into the best pathways to accelerate approvals.
An integrated team of experienced neuroscience advanced clinical practitioners (ACPs) enrich the team with added medical and clinical perspectives, while providing a patient-centric and site-centric perspective to proactively address protocol challenges.
Key Sleep Disorder Indications
Medpace medical, regulatory, and operational experts bring a broad range of experience in designing and conducting sleep disorder studies. Areas of focus include:
“As a fully integrated, cross-functional global team that specializes in the design and conduct of sleep disorder clinical trials, Medpace accelerates the development of safe and effective medical therapeutics. I am proud to be part of this team as an ACP, enriching our in-house medical and operational expertise.”
Morgan Ball, MSN, APRN Advanced Clinical Practitioner, Medpace
“As a Medpace ACP with experience seeing patients with sleep disorders, my former patients drive me to further the Medpace mission of accelerating the development of safe and effective medical therapeutics. The sleep disorder patient community has a significant unmet need and the work we do every day in clinical trials offers them hope.”
“Our role is to realize the Sponsors’ vision. We leverage our expertise and experience to deliver therapeutics to patients in need. This has been especially important for novel therapeutics, routes of delivery, and for indications without established study design. By the time patients are evaluated with symptomatic presentations in the clinic, we are seeing the neurological manifestations of underlying disorders that have developed over months, years or decades. Sleep neurology gives us the opportunity for early intervention to maintain brain health rather than treat neurologic disease. “
Boban Joksimovic, MD, PhD Medical Director, Medpace
