Accelerating Drug Development in Global Neuroscience Clinical Research
Despite strong advances in neuroscience research into the brain and mechanisms that underlie brain disease, challenges remain in successfully developing new medicines for the treatment of neurologic and psychiatric diseases. Patient recruitment, high trial costs, the burden imposed on patients and caregivers, and lower than average success rates are some of the many key considerations that influence the successful conduct of neuroscience clinical trials.
Drive your neuroscience trial success with Medpace’s well-established site relationships, exceptional clinical operations, and cross-functional, neuroscience-focused study teams. Our experienced neuroscience team leverages their real-life experience in a wide range of relevant indications and therapeutic platforms to support Sponsors in meeting the unique challenges of neuroscience clinical development.
Medpace accelerates drug development across all neuroscience areas including:
Making the Complex Seamless® in Global Neuroscience Clinical Trials
Neuroscience clinical research is a key therapeutic focus for Medpace, a full-service clinical research organization (CRO). Sponsors from emerging biotechs to global pharmaceutical companies have trusted Medpace for over 30 years to lead their Phase I-IV neuroscience clinical trials spanning adult and pediatric populations in a wide range of neuroscience indications, therapeutic platforms, and routes of administration. Leverage our broad experience in advancing new neuroscience treatments and specialized expertise in the design and management of complex neuroscience programs to keep your trial on time and on budget.
Neuroscience CRO Capabilities
Partner with our cross-functional team of medical, operational, and regulatory experts to proactively anticipate challenges while creatively approaching neuroscience trials to successfully navigate rapidly evolving regulations, operational complexities, and tight timelines. Our neuroscience clients benefit from:
Global regulatory affairs team able to lead, consult, and manage complex regulatory approval processes along with an experienced regulatory submissions team to facilitate expedited start-up
Dedicated medical device division to support drug-device combination products and drug delivery products
In-depth knowledge of screening tools and rating scales to facilitate and provide oversight for rater services including subjective assessments, inter-rater reliability, and scale validation
Extensive early phase and transitional development expertise supported by our Phase I Unit
Fully integrated real-time information supported by our proprietary CTMS, ClinTrak, providing IWRS/ IVRS, study management, data management, laboratory management, image management, and endpoint adjudication
Extensive experience with the different therapeutic platforms (small molecules, monoclonal antibodies, blood derivatives, RNA and DNA therapies) and routes of administration (oral, parenteral, intrathecal, intracisternal, intraparenchymal)
Patient recruitment and retention continue to be a challenge in clinical development and the success of clinical trials is wholly dependent on the success of sites and the engagement of patients. Our proprietary IntelliPACE®feasibility strategy and dedicated in-house recruitment and retention team deliver custom-tailored recruitment strategies to support the unique needs of each trial.
Patient-Centricity
Medpace engages with advocacy groups in a variety of areas. For example, Medpace is an active member of the World Muscle Society, a non-profit organization dedicated to advancing knowledge in the neuromuscular field by providing a scientific forum to advance and disseminate knowledge for the benefit of patients.
To ensure clinical trials are designed and executed with patients in mind, Medpace can help Sponsors forge new relationships with specialized patient advocacy groups across the globe and can support existing relationships seamlessly.
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Considerations for Neuroscience Trials with Intrathecal Delivery and Other Methods of Direct CNS Administration
High-quality image acquisition and interpretation are crucial for the success of trials relying on neuroimaging for patient selection or use as a primary or key endpoint. Medpace provides centralized neuroimaging expertise, led by radiologists and neurologists with decades of clinical and trial experience.
Medpace Imaging Core Lab provides an end-to-end suite of imaging services to enhance and expedite biopharmaceutical and imaging contrast agent development, including consultation on imaging biomarker strategies, image acquisition protocols, image collection/archiving services, and image analysis across imaging modalities and therapeutic areas.
Streamline the execution of neuroscience clinical trials through Medpace’s comprehensive and fully-integrated central and bioanalytical laboratory services. We offer a wide range of relevant biomarker assays for neuroscience and have the ability to rapidly establish and validate novel assays as needed. Additionally, with one of the highest PhD to staff ratios in the industry, Medpace successfully performs the bioanalytical component of PK studies at all phases of neuroscience drug development.
Success Stories in Neuroscience Clinical Research
Enable timely enrollment and high-quality conduct of trials by selecting the best sites for your specific program through our broad neuroscience experience and long-term relationships with experienced sites, networks, and key opinion leaders (KOLs).
“You know you are doing something right when you have a highly complex opportunity with a new client come to Medpace that’s not competitively bid. It was exciting to hear that the client came to Medpace via referrals from sites they had engaged for feedback on their trial design and ability to execute. Medpace takes pride in building strong relationships with our sites and working to minimize burden. Receiving this feedback positively reinforces our approach.”
Jennifer Gehlhar, MS
Vice-President Clinical Trial Management, Medpace
“Our role is to realize the sponsors’ vision. We leverage our expertise and experience to deliver therapeutics to patients in need and return the insights and data to accelerate product development and registration. This has been especially important for novel therapeutics and routes of delivery, and for indications without established study design.”
Richard Scheyer, MD
Sr. Vice-President, Medical Department, Neuroscience & Rare Disease, Medpace
[Video] Medpace Neuroscience Advanced Clinical Practitioner Team
Neuroscience Clinical Trial Experts
Our experienced global team of neuroscience-dedicated medical, clinical, and regulatory experts have decades of experience managing and executing neuroscience trials around the world. With lower-than-industry-average turnover, study teams typically remain consistent from project initiation to completion, producing truly seamless drug, device, and in vitro diagnostics (IVD) development.
Embedded, in-house neuroscience physicians provide strategic direction of study design and planning, train operational staff, work with Primary Investigators (PIs), provide medical monitoring services, and meet with regulatory agencies for neuroscience projects. Our medical experts are supported by an integrated team of experienced neuroscience clinical practitioners that bring patient-centric and site-centric perspectives to your study while providing an additional layer of insights to proactively address protocol challenges.
