With the finalization of the FDA guidance in 2017, driving simulation studies are now required for any drug that may affect cognition. Driving simulation studies are the ideal way to collect data required for the drug label when pre- and early clinical studies show that a drug may cause somnolence or impair cognition. Our experts can design and conduct driving simulation studies to efficiently determine the extent and duration of driving ability impairment.

At Altasciences, we design driving studies to achieve your objectives, leveraging extensive experience across clinical testing of cognitive effects. We partner with Cognitive Research Corporation to use their proprietary driving simulators, nine of which are permanently installed in our clinic. We have performed well over 10,000 simulated drives to date, analyzing the impairment seen at peak exposure and/or the effect seen the morning after evening dosing.

We have a suite of ten simulators on site at our clinical facilities, with space for more than 20 additional, as needed. Professional oversight is provided by fully-certified, in-house driving simulation study specialists.

Consult our general Driving Simulation Fact Sheet

Our comprehensive, integrated proof of concept (POC) study services help you achieve your critical milestones faster. Our experts in the design and conduct of phase I clinical trials will deliver your clinical research efficiently, effectively, and on time. With the research support of regulatory experts, bioanalytical scientists, experienced biostatisticians and medical writing teams, you can trust Altasciences with your POC studies. Proof-of-concept studies present unique challenges in both design and conduct. Working with a CRO skilled in both is vital for the success of your Phase I clinical trial program. Altasciences has designed and conducted a wide range of FIH and stand-alone proof of concept clinical trials.

Consult our NDA-Enabling Fact Sheet

Proof of Concept (POC) Study Conduct Expertise

Our clinical pharmacologists perform background research, and consult with research specialists, to ensure we craft the ideal design to meet your objectives, including collaborating with our preclinical colleagues to select the models or biomarkers that translate from preclinical to clinical. Our clinical trial teams capture the endpoints in a consistent manner, training our staff to administer both objective and subjective proof of concept study tests in the exact same way. We also carefully educate participants in what is expected of them during a Phase I clinical trial.

We routinely perform POC clinical research in healthy participants, and leverage our access to a wide range of patient populations for indications that do not have models appropriate in healthy participants. Prior to starting a proof of concept study, our recruiting department produces an accurate estimate of recruitment numbers and timelines. For some indications, we can recruit a large number of patients (i.e., more than 50 patients in areas like diabetes, obesity, and osteoarthritis), while in others, we conduct POC research with smaller groups.