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Experts in Assessing
Drug Impact on Driving
Mitigate Risk,
Optimize Your
Drug’s Impact
An adverse driving label can significantly reduce a drug’s marketability, impacting both current medications and those in development. Assessing whether a drug affects driving, the duration of impairment, and the impact of chronic dosing is crucial for strategic asset management.
With CRC’s state-of-the-art CRCDS MiniSim, developed in partnership with the University of Iowa’s Driving Safety Research Institute, you gain access to the only dedicated driving simulator validated for multi-site clinical trials.
Key Benefits:
- Established benchmark for 0.05% BAC driving impairment–the FDA’s gold standard
- Sensitive to both therapeutic and adverse effects on driving
- Faster completion compared to over-the-road studies
- Expert team with 18+ years of conducting dedicated driving studies with CRCDS MiniSim
CRCDS MiniSim:
Precision Driving
Studies for
Multi-Site Trials
The only simulator built for multi-site clinical trials and precision measurement of driving impairment.
Our proprietary CRCDS MiniSim offers highly immersive, realistic driving simulations that confirm to FDA guidance for dedicated driving studies. Validated to detect impairment at 0.05% BAC, it delivers precision, reliability, and actionable insights.
Advanced 3D Simulations: Realistic roadway environments, vehicle dashboards, intersections, traffic devices, and secondary task displays.
Precision & Reliability: Acute sensitivity to both therapeutic and adverse effects, delivering dependable study results.
Flexible Deployment: MiniSims can be set up across 1 to 12+ units at phase 1 units and outpatient research clinics.
What Impacts Will Your Drugs Have on Patients Driving?
Understand How Drug Side Effects Impact Driving.
When developing CNS therapeutics, understanding how a drug impacts driving is a critical safety determination. CRC’s dedicated driving studies provide clarity across every stage of development, from early-phase trials to post-market surveillance.
Our studies help determine:
- Optimal labeling and product differentiation
- Safe resumption of driving after psychedelic or CNS therapy
- Regulatory compliance, including FDA-required studies
- Transition from prescription to OTC drugs
Your CNS Driving Study Experts.
CRC combines technical expertise, regulatory insight, and a single-minded focus on CNS drug safety. We guide your team confidently through complex challenges, delivering clarity and results when it matters most.
Key highlights:
- Proven track record influencing FDA drug approvals and labeling
- Multi-site study expertise with MiniSim technology
- Cost-effective, reliable, and fast study execution
- 30+ MiniSims, with capability of setting up 1 – 12+ sims at Phase 1 units and outpatient research clinics
- 20+ Driving studies, including phases I – IV
get in touch