For Phase 1-3 CNS Trials
Powered by deep, indication-level expertise, over 25 years of global experience, a proven process, and the latest technology, Clinilabs’ early phase development services are your pathway to CNS approval.
Trust the CNS CRO
Clinilabs is the premier full-service CRO focusing exclusively on CNS drug, device, and technology development. We’ve conducted more than 800 CNS clinical trials in North America, Europe, and Asia, and have played a pivotal role in the approval of 22 new therapies across 13 CNS indications.
As you move forward on a path specially designed for your program, our integrated, expert team works in concert to produce high-quality, submission-ready data for your drug or medical device on time, every time.
Complete Early Phase Development Services
Designed to expedite the development of CNS therapies, medications, and devices, our clinical trial management services are the high-quality, timely, and cost-effective solutions you need.
Clinical Trial Project Management
Clinilabs has the most diverse and well-trained clinical project management team in the industry. Our built-in agility, dedicated project leads, and high-touch communication minimize friction and keep your trial on track to completion.
Our project managers have one focus at a time: your study. Their unparalleled service, scientific know-how, integrity, and operational expertise ensure personalized service that meets your needs, regardless of project scope or size. From rapid study startups to seamless auditing, they always deliver on time and on budget.
Our project management teams are also well-versed in local culture, global regulatory environments, and complementary clinical trial management systems, trial master files, and electronic data capture to ensure seamless study integration across the globe.
Clinical Trial Monitoring
Our clinical trial monitoring services include clinical and medical monitoring to keep your trial on track and your patients well cared for.
Medical Writing Services
From project inception to the final clinical study report, the Clinilabs medical writing team provides exceptional medical, technical, and regulatory writing services, including:
- Clinical study synopses, protocols, reports, and report verification
- Protocol amendments
- Investigator brochures
- Informed consent forms
- Patient information sheets
- Study newsletters
We only employ veteran medical writers with advanced degrees and unmatched CNS therapeutic area experience to ensure study documents meet expectations, whether we’re working with our templates or yours.
Site Selection Services
Clinical trial site selection is critical, especially in CNS indications with rare or sensitive patient populations.
Our expansive network of investigator sites in 42 countries has a robust operational infrastructure to support international multicenter trials and independent, engaged investigators who have been pre-identified for their access to patients with CNS disorders — creating virtual waiting rooms ready to fill your study.
We have deep-rooted, long-standing relationships with these researchers, allowing us to confirm that they consistently exceed expectations for subject accrual and diversity, data quality, and timelines while maintaining a patient-centric approach.
Electronic Case Report Forms (eCRFs)
We provide eCRFs on multiple platforms, including Medidata RAVE and Medrio. Working in accordance with CDASH and CDISC standards, we also offer:
- Automated, customized data queries
- Reconciliation of queries, AEs, and SAEs
- Real-time clinical trial metrics and reports
- Prompt delivery of hard-locked database
Biostatistics Services
Our clinical trial data management solutions also include a full portfolio of biostatistics services delivered by a team of advanced statisticians who are experts at:
- Power calculation
- Randomization and blinding
- Statistical analysis plans
- SAS programming
- Production of tables, listings, and figures
- Database integration and integration summary
- Statistical reports
Choose between standardized statistical tables, listings, figures, and reports to help you save time and money or customized services, including statistical programming, to support even the most demanding study requirements.
All clinical trial data are retained at our validated technology center in the United States, and our expertise in the implementation of CDISC standards gives you confidence that data can be submitted to regulatory authorities in a high-quality, defendable format.
Clinical Trial Programming and Database Architecture
Our highly skilled clinical database programmers provide general and SAS programming services to meet your study needs, including:
- Programming plan, user specifications, and database architecture and design
- Coding that is simple and easy to understand
- Program validation
- Flexibility, so you can modify codes or apply templates to new projects or study designs
- Programs that run efficiently on execution
We complete programming at study start and within expected timelines to ensure your data can be processed according to plan.
Technology Supporting Our Clinical Trial Data Management Solutions
Clinilabs uses top electronic data systems like Veeva Vault and Medrio to support everything from eCOA/ePRO and EDC to clinical databases and more.
CNS Trial Accelerators
We offer a range of solutions beyond our clinical trial management services to keep your trial on track from first patient in to last data out.
Complete Support for Your Phase 1 CNS Trial
When you use Clinilabs’ clinical research units, you’re not just accessing top-tier facilities and clinical services. You’ll also have access to our comprehensive CRO services to accelerate and enhance every aspect of your CNS clinical trial.
