Clinical Trials

CNS Vital Signs has rapidly become a world leader in the delivery and management of computerized cognitive testing in international clinical trial research. Over 2000 investigators have utilized the CNS Vital Sign platform over the past 5 years across a large spectrum of diseases. Our sponsors span the range of Fortune 500 companies to the most virtual of Biotechs. Our experience spans the spectrum of Phase I-IV research, investigator initiated trials, government research, and extensive academic research.

CNS Vital Signs provides researchers (Pharmaceutical Companies, Biotechs, Nutraceuticals, Academic Researchers, etc) with leading edge neurocognitive assessment technologies that allow sponsors and investigators to rapidly assess a patient's brain function. Our extensive library of computerized neuropsychological tests and evidence-based rating scales allow researchers to efficiently evaluate a broader view of neurocognition, behavioral health, comorbidities, or neurobehavioral health status.

CNS Vital Signs offers researchers a flexible testing platform. In addition to a local running software option (laptop or desktop), more and more sponsors are taking advantage of the CNS Vital Signs web platform, which introduces tremendous efficiencies to the management of cognitive testing across the clinical trial setting. The web based platform produces sound data while saving time and cost. Real-time assessment of data results allows for better management of sites and early detection of data trends that could affect important trial endpoints. Early detection of trends can play a critical role to proactively tackle potential issues in your study.

Services Offered:

• Protocol review and consultation
• Web or local testing platform options
• Customized programming of test battery to meet protocol requirements
• Site set-up (including hardware provisioning when applicable)
• Training offered for Investigator meetings, webinars, and at site level
• Data management
• Project management
• Data analysis
• Project support line (phone and email)

CNS Vital Signs Benefits and Features:

• Scientifically valid and reliable tests
• Millisecond precision 
• Available in over 50 languages
• Standardized test administration and scoring that eliminates variability
• A paper or electronic data capture options
• Minimal rater training required 
• Straight forward hardware requirements (e.g., Windows-based PC)
• Internet enabled but not internet dependent
• Unmatched ease of use for the site or clinic 
• Immediate and automated post-test scoring; all scoring occurs locally with no need to send a file across the internet to be scored 
• Patient acceptability - the tests are intuitive, brief, and well accepted by patients
• Customized testing designed to yield the domains required for your project by providing the ability to craft batteries from 4 minutes to 45 minutes or longer depending on your research requirements 
• Custom rating and symptom scales can be easily added to the battery 
• Data collection flexibility to match budget and data gathering preferences, from "paper" source / CRF transcription to automated data collection with the data delivered to a CNS Vital Signs server. 
• CNS Vital Signs is 21 CFR Part 11 compliant

Clinical Research and Pharmaceutical Development

CNS Vital Signs CEO, Alan Boyd's interviewed on the "Conversations with Industry Leaders" section of the Trial Acceleration Institute website. Listen...

CNS Vital Signs provides a variety of solutions to meet most any researcher's neurocognitive testing needs. The CNS Vital Signs test battery is available in over 50 languages and has been utilized as a research tool in over 35 countries worldwide.

To date, researchers have used CNS Vital Signs to measure drug and treatment differences in many disease and therapeutic areas. CNS Vital Signs' precise measurement of neurocognitive clinical endpoints helps researchers differentiate their compounds within an affordable budget. In addition, since the scored report is available immediately, timely inclusion / exclusion / randomization / safety decisions can be made by investigators at the site at the time of patient visit. There are other operational efficiencies CNS Vital Signs utilizes to solve the problems historically associated with large scale, worldwide clinical research implementation.

CNS Vital Signs has been solving the problem of implementing large multinational clinical research projects since 2004. Our customizable, easy to implement testing platforms allows sponsors to start neurocognitive testing in early stages and then test across until submission and into post approval safety studies. 

As a service to clients, CNS Vital Signs provides consultation to determine neurocognitive domain selection and assist with protocol design. The test is sensitive to a variety of drug treatments and neurocognitive disorders including: AD/HD, MCI, Alzheimer's disease, Bipolar Depression, Brain Injury, Parkinson's disease, Schizophrenia, Stroke, Various dementias, and other diseases where neurocognitive deficit is associated with the study condition.

WE PROVIDE...

Customized Language Selection:

Choose from:
Afrikaans — Arabic — Bengali — Bulgarian — Cebuano — Chinese Simplified (China) — Chinese Simplified (Malaysia) — Chinese Traditional — Croatian — Czech — Danish — Dutch — English (United States) — English (United Kingdom) — Filipino — Finnish — French — French (Canada) — German — Greek — Gujarati — Hebrew — Hindi — Hungarian — Ilocano — Indonesian — Italian — Japanese — Kannada — Korean — Latvian — Malay — Malayalam — Marathi — Norwegian — Polish — Portuguese (Brazil) — Portuguese (Portugal) — Punjabi — Romanian — Russian — Serbian — Sesotho — Slovak — Spanish (Latin America) — Spanish (Mexico) — Spanish (Spain) — Swedish — Tagalog — Tamil — Telugu — Thai — Turkish — Ukrainian — Urdu — Xhosa — Zulu.

Customized Data Collection:

Data generated from CNS Vital Signs applications is easy to understand and describe. Treated like any lab data, sponsors can easily perform their own analysis. Most clients choose electronic data upload where the investigator site sends the data to hosted colocation centers. Electronic data options allow the sponsor to obtain their data quickly. CNS Vital Signs offers the ability to custom configure data collection methods to meet operational and research needs.

The choice of data collection method is designed to fit the way most any sponsor collects data. Here are examples of some common options:

• Paper reports with transcription
• Paper reports with electronic data upload
• Electronic data upload without paper reports
• Academic and pharma customers participating in investigator initiated trials have the option of having the date file created locally so there is no waiting for a dataset or hand-entering data.

Customized Battery Design:

Customizable Scales and Questionnaires can be added to your custom build to suit your research needs.

Government and Academic Research

Students, interns, residents and fellows doing research receive additional discounts, as do academic and government groups. Research must be of scientific merit and a brief description of the project is necessary.

Pharmaceutical companies and other researchers requiring customization or additional language support should contact CNS Vital Signs directly with their specific requirements.