CNS trials are hard. We get them right.

ObvioHealth designs, deploys, and delivers CNS clinical trials with scientific rigor and operational accountability to get you to LPO, faster.

CNS clinical trials are hard.

We know, because we’ve been there.

We do them better.

The Hard Facts of CNS Clinical Trials

1 billion

people worldwide have a CNS condition.1

7 million

people globally die from a CNS disease every year.1

85%

of CNS clinical trials fail.2

36%

average additional time for FDA approval of CNS drugs versus other meds.3

Pharmaceutical and biotech companies are diligently working to develop new therapeutics to meet the massive global burden caused by CNS diseases. Despite this, CNS therapeutic development successes are notoriously scarce.

Individuals with CNS conditions can experience mobility and cognitive issues and require regular caregiver support, making these trials complicated and burdensome for both participants and their caregivers. In many cases, medication adherence can be a challenge: Participants may stop using the therapeutic when they feel better. And, in studies collecting subjective endpoints, data variability can derail your results.

With so many challenges, getting a CNS trial to completion can be far from linear. To succeed, you need a partner that can design, deploy, and deliver your study with scientific rigor and operational accountability.

1. Nuno Perez Á, Suarez J, Le Bars M. Sizing the brain. Deloitte Insights. February 14, 2023. Accessed January 8, 2024. https://www2.deloitte.com/uk/en/insights/industry/health-care/global-neuroscience-market-investment-report.html
2. Wong CH, Siah KW, Lo AW. Estimation of clinical trial success rates and related parameters. Biostatistics. 2018;20(2):273-286. doi: 10.1093/biostatistics/kxx069
3. Myers W. CNS Drugs Take Longer to Develop, Win Approval. CenterWatch. September 17, 2018. Accessed January 9, 2024. https://www.centerwatch.com/articles/12495-cns-drugs-take-longer-to-develop-win-approval

Learn from our experience.

Each CNS indication has its distinct challenges. Careful attention must be paid to best practices for reducing participant burden, ensuring data accuracy, minimizing placebo effect, and boosting retention and compliance. These will vary depending on the patient population, protocol requirements, and desired endpoints. ObvioHealth’s digital methods provide concrete solutions to help mitigate the risks.

Neuropsychiatric

  • Providing remote options for populations with mobility or cognitive impairments can help to reduce burden associated with travel to a traditional site—and ease recruitment challenges.  
  • User-friendly data collection methods, developed with accessibility in mind, can make it easier for those with fine motor impairments and cognitive challenges to use digital solutions.

Neurodevelopmental

  • These clinical trials often require caregiver involvement, especially for pediatric and older populations. Collecting observer-reported outcomes (ObsROs) electronically and remotely can reduce burden and recall bias.  
  • Notifications to remind caregivers—who already have a lot to remember—when a task is due can increase compliance and reduce missing data.
  • Remote data capture can provide a more well-rounded picture of symptoms that are influenced by setting or context.

Neurodegenerative

  • Providing remote options for populations with mobility or cognitive impairments can help to reduce burden associated with travel to a traditional site—and ease recruitment challenges.  
  • User-friendly data collection methods, developed with accessibility in mind, can make it easier for those with fine motor impairments and cognitive challenges to use digital solutions.

Pain

  • Participant training is key to reducing the placebo effect for a subjective outcome such as pain. Trial sponsors might also consider combining subjective data with more objective data, such as activity tracking.  
  • With easy-to-use NRS and VAS scales, data can be captured in real time and more frequently, as pain ebbs and flows.
  • People don’t want to travel to clinics when they are in pain; reducing burden and offering remote options can increase compliance and retention.

Explore our case studies.

How we get your CNS trial to completion.

ObvioHealth tackles CNS studies with its unique combination of science, innovation, and pragmatic study management.

  • Scientific Expertise: Designing and digitizing your study for success.
  • Innovative Technology: Deploying your study faster and capturing data remotely.
  • Operational Excellence: Keeping your study on track.

Scientific Expertise

Endpoint and Outcome Measurement
We start with the end in mind to ensure endpoints are relevant for your population. Then, we use our deep knowledge of outcome assessments to help you identify the measures that will deliver the evidence you need—without overburdening participants.
Cohort Design
We understand the balancing act of cohort design. We help you define the exclusion and inclusion criteria that target the right participants and ensure the evidence you need.
Participant and Expert Training
Our clinical science teams plan and deploy training programs that ensure robust digital data capture and mitigate against placebo effect and data variability.  

Innovative Technology

Study Design
  • No-code platform reduces study build time by up to 70%.
  • Quickly configure your study and publish it to a test app.  
  • Identify and correct hiccups in the trial journey before they happen.
Mobile App
  • eConsent, ePRO, and push notifications reduce burden.  
  • Participant-facing interfaces are designed to be easy and simple to navigate.
  • On-demand chat feature closes the gap between patients and site teams.
Study Management
  • Live dashboards provide full-funnel visibility into how your trial is progressing—from recruitment to LPO.
  • Alerts notify study and site teams when a participant has a change in health or a lapse in compliance.

Operational Excellence

Project Management
Our project managers are trained to use the ObvioGo® platform and app from the perspective of a site manager and a participant. We are our own toughest customers, because we operate the trials we build.
Virtual Site Team
ObvioHealth is one of the rare companies to offer a virtual site team staffed with experienced study coordinators (COACHes) who provide personalized support to participants and sites.

Our Proof

99%

Retention*

90%

Medication Adherence*
*From previous CNS clinical trials.

Happy Clients

"ObvioHealth helped us figure out how to keep patients engaged without giving them more migraines. Incorporating the live chat feature and notifications into the project has eased the connection for the participants."

Steve Schaefer, CEO, Mi-Helper, Inc. 

Happy Participants

“I had all my questions answered. It was simple.”​

Trial Participant

“The entire process was very simple and easy to navigate.”​​

Trial Participant

“I sent a thank you note when I was done, because I felt like I had a kind of personal relationship with the staff.”​

Trial Participant

"It was pretty much seamless from the start. From scheduling the whole appointment and the contact, there was always help from the research team.”​

Trial Participant

​“I have been involved in other studies where I carried around their study device. Having the app on my phone and just one device, made it so much easier ”​

Trial Participant

“I would just get the notification and then go to the app and answer the survey questions. They had a screening questionnaire, and it was just easy to just go through and mark my answer, go to the next activity and hit submit.”​

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