Clinilabs Is Your MedTech CRO
From intricate regulations to pricing pressures and evolving market demands, medical technology (MedTech) development is uniquely challenging. With even more data, regulatory, and reimbursement complexities, CNS MedTech development is nearly impossible — unless you partner with Clinilabs.
With industry-leading experience in the optimal management of clinical development projects for diagnostic and therapeutic medical devices, consumer devices, and technologies, we provide our clients with the highest level of support for 510(k) and premarket approvals (PMA).
36
MedTech Trials Conducted in Less Than 10 Years
25+
Device & Technology Categories
Real-Time
Device Integration
What You Get When You Partner With a Relentless MedTech CRO
We offer an ideal combination of proficient experts and advanced systems to develop, integrate, and validate new technologies in a high-quality, timely, and cost-efficient manner.
End-to-End Support
We help advance CNS MedTech through:
- Preclinical
- Pre-market approval (PMA)
- 501(k)
- Global regulatory submission
Real-Time Device Integration
We use application programming interface (API) integration to stream data from medical and consumer devices such as wearables, implants, and apps to a world-class data center.
Secure Data Solutions
Now, more than ever before, clinical trials include the collection of data from medical devices and wearables. These data often are critical to the assessment of efficacy and safety, yet they can be difficult to manage, coordinate, and integrate into routine clinical datasets. Clinilabs offers solutions to meet today’s data management challenges.
Clinical Insite 2.0 is a validated solution that makes device and wearable data accessible and interoperable. It enables the collection, transfer, and processing of digital medical device and wearable data via a secure, cloud-based application designed to be complaint with Federal and international regulations governing the handling of digital data. Data may be captured and transferred from investigator sites, or directly from the instrumentation in real time.
Trust the CNS MedTech Experts
From artificial intelligence (AI)-driven diagnostics to drug-device combinations, we’ve managed trials in over 25 device and technology categories — supporting innovations at the intersection of consumer and research studies for our clients and firmly cementing our place as the premier MedTech CRO:
- Verification and validation
- Virtual trials
- Decentralized trials
- AI tools and technologies for patient monitoring devices
- Real-world studies
- Intramuscular data collection
- Intra-arterial data collection
- Continuous glucose monitoring
- Blood pressure monitoring
- Algorithm development
- Wearables
- Sleep diagnostic devices and therapeutic devices
- Transcranial electrostimulation
- Positive airway pressure
- Light delivery
- Hypoglossal nerve stimulation
- Home sleep testing
- Implants
- Drug delivery and drug-device combination products
- Medical device software, systems, and mobile applications
- Light delivery
- OTC and consumer products
Don’t see your device or technology listed? We can customize solutions for your clinical trial.
Need Support for Another Type of CNS Trial?
As the CRO for CNS, we have unmatched experience in all other key CNS indications.
