Driving Simulation Studies
Apex conducts driving simulation studies to evaluate the effects of a wide variety of drugs on the driving performance of healthy and patient populations. Our expertise helps sponsors efficiently meet the requirements of the FDA’s 2017 guidance document which states that a dedicated driving study is required (pre-approval) under conditions where evidence indicates a potential for driving impairment. We deliver accurate driving performance data at lower cost and with less risk than over-the-road testing.
We Offer One Or Two-site Solutions
Apex’s trial site organizations, HRI and CNS, have six driving simulators each at their respective Berlin, NJ, and Long Beach, CA locations. Our two-site model can improve clinical conduct timelines without risk to quality. The two sites are calibrated in the conduct and administration of assessments in such studies.
HRI and CNS conducted a two-site driving study of tolperisone, a centrally acting muscle relaxant, which demonstrated it performed similar to placebo and with less impairment than cyclobenzaprine. The study was sponsored by Neurana Pharmaceuticals.
We partner with Cognitive Research Corporation (CRC) to use their proprietary state-of-the-art CRCDS MiniSim driving simulators which are proven to be highly sensitive to both therapeutic and adverse drug effects. The driving scenarios developed for the CRCDS were designed to assess a range of psychomotor, divided attention, and cognitive tasks involved in driving. CRC’s President/Chief Scientific Officer, Dr. Gary Kay, is an internationally recognized expert in driving simulation.