Neurology was the second leading therapeutic area, behind Oncology, to gain drug approval from the FDA in the past five years. Even with a drop in overall approvals in 2021, the therapeutic area remains one of the fastest growing.
Funding for neuroscience clinical research from the NIH in 2021 was 10.7 billion dollars, a substantial increase from 5.3 billion dollars in 2013. There are several reasons for the growing interest in this field, including improved imaging techniques, increased availability of biomarkers for neurological diseases, and a likely increase in the prevalence of diseases such as Alzheimer’s disease, Parkinson’s disease, and Multiple Sclerosis, with an aging U.S. population.
Despite the recent success in drug approvals in the neurology or central nervous system disease space, a significant proportion of trials are unsuccessful. Many sponsors are partnering with clinical research organizations (CROs) specializing in neurology and CNS indications who can provide expedited clinical trial management services. A good CRO’s defining characteristic is the ability to streamline and efficiently conduct clinical trials.
How Can CROs Assist in Neurology Clinical Trials?
CROs provide a number of services to manage the different aspects of clinical trials. Most CROs offer assistance with the selection and start-up of clinical sites, meeting regulatory requirements, participant recruitment, project management, data capture and management, clinical trial monitoring, expertise in the therapeutic area, and data analysis. The experience and strategies brought by the CROs can significantly impact the efficiency, execution, and success of the clinical trial.
In addition, CROs may specialize in specific therapeutic areas and diseases or provide unique technology services. The modality of the therapy being tested, therapeutic space, geographic location, and target population should be considered when choosing a CRO for your clinical trial.
Below, we list the top five small neurology CROs to consider for your clinical trial.
1. Musculoskeletal Clinical Regulatory Advisors (MCRA)
MCRA is a full-service CRO specializing in medical devices and biologics and has supported companies and therapies in all stages since 2003. While headquartered in Washington, DC, MCRA provides international expertise in executing clinical trials in the United States, Canada, Europe, and Japan.
CRO services provided by MCRA include:
- Trial site selection
- Site start-up
- Budgeting
- Data management
- Quality assurance
- Vendor management
- Medical writing
- Regulatory submissions for IND and NDA applications, and post-marketing studies
They also recently expanded their biostatistics division. In addition, MCRA also provides consultation services for reimbursement and cybersecurity of medical devices. MCRA’s experience in neurology spans the breadth of neurological indications for which they have assisted in developing devices, including devices for ambulation, cognitive function, electrophysiology, neurodiagnostics, neuroimaging, neurostimulation, and neurointerventions.
2. Clinscience
Clinscience is a global CRO with over 20 years of international clinical trial experience, which provides end-to-end CRO services from protocol development to submission of the Final Study Report. Located in Warsaw, Poland, Clinscience has hubs across the United States, India, Italy, Spain, and Germany. Clinscience leverages digital technology to simplify the clinical trial process through Exom Group‘s GeniusTM Clinical Trial Management System, which uses decentralized data management, allowing for real-time access and analysis. Clinscience has managed over 500 studies for over 24 therapeutic areas. Clinscience’s neurology network comprises neurologists and neuroradiologists with expertise in multiple sclerosis, Alzheimer’s disease, Parkinson’s disease, and beyond.
3. Vial Health Technology
Vial is a next-generation, tech-enabled, full-service clinical research organization founded in San Francisco, California.
A few of the CRO’s services include:
- Trial development
- Site selection, and 30-day site start-up
- Patient enrollment
- Clinical operations
- Data management and analysis
- Quality assurance
- Vendor management
- Medical writing
- Regulatory submissions for IND and NDA applications, and post-marketing studies
Vial has a team of project managers and Clinops with expertise in several therapeutic areas, including neurology, to help support the clinical trial. Vial’s goal is to reimagine the clinical trials process and create the most efficient, streamlined service using technology to connect electronic data capture (EDC), electronic data entry and monitoring through eSource, and electronic patient-reported outcomes (ePRO) on an integrated digital platform. Using this technology and other strategies, Vial promises quick site start-up within 30 days. Through fixed-fee pricing, Vial also provides the lowest cost for value. Vial Neurology CRO brings with it the expertise of its team of Neurology/CNS scientific advisors.
4. Global clinical trials (GCT)
Global Clinical Trials (GCT) provides international clinical trial CRO services through its primary headquarters in Princeton, New Jersey, and 11 satellite locations in the US, Europe, and Asia. GCT has over 20 years and 400 completed trials of experience in providing CRO services and offers support for trials through all phases, I–IV, as well as post-marketing trials.
CRO services provided by GCT include:
- Site start-up and management
- Project and vendor management
- Clinical trial monitoring and quality assurance/quality control
- Data management and statistics, regulatory affairs, and medical writing
In addition, GCT also owns a drug storage and distribution center in Russia.
5. Accelsiors
Accelsiors CRO was established in 2002 in Budapest, Hungary, and provides global CRO services through its offices in Hungary, the United States, and India. Accelsiors is a full-service CRO providing services that include:
- Study start-up and feasibility
- Clinical monitoring
- Pharmacokinetics/pharmacodynamic modeling
- Project management
- Data management and quality assurance
- Regulatory affairs, medical writing, and biostatistics
Accelsiors brings therapeutic knowledge in various fields, including neurology, with an interest in conducting research in biosimilars and pediatric studies. Accelsiors has focused its mission on ensuring research with access to treatment-naive patient populations.
To learn more about how Vial’s products are delivering faster, more efficient trial outcomes for dramatically lower costs, connect with a team member today!
