Drugs that contain psychoactive or sedative pharmaceutical ingredients which could alter the ability to operate a motor vehicle require driving simulation clinical trials. In 2017, the FDA finalized a guidance that proposes a tiered approach to such studies, consisting of pharmacological/toxicological, epidemiological, and standardized behavioral assessments to evaluate possible drug effects on driving, starting early in clinical development.

Over the past decades, Altasciences has designed and conducted over 200 first-in-human and stand-alone proof-of-concept studies. Our comprehensive, full service, early development offerings and experience help you develop sound strategies and allow you to minimize the time taken to make critical go/no-go decisions by harmonizing our clinical pharmacology facilities, biomarker capabilities, PK/PD analysis expertise, and program knowledge.

Altasciences' specialists apply their decades of experience in designing, conducting, analyzing, and reporting on trials for regulatory submissions, across the spectrum of therapeutic areas.

Unclear as to which studies may be required?

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• Proof-of-Concept in Special Populations
• Renal and Hepatic Impairment
• Drug-Drug Interaction
• Thorough QT
• Human Abuse Liability or Potential
• Cognitive Assessment Driving Simulation
• Elderly
• And more

As an alternative to traditional venipuncture, blood microsampling represents a less invasive and simplified collection technique, resulting in numerous benefits for preclinical and clinical studies alike. Recent advances in device technology, specifically the Mitra® VAMS® microsampler manufactured by Neoteryx, has enabled Altasciences to fully support blood microsampling programs.

With over 12 Mitra® VAMS® assays validated for a range of drug applications and study types, we look forward to sharing our combined expertise in support of your next microsampling program.

At Altasciences, we understand your clinical trials are unique and require careful management. As part of our partnership with you, our highly experienced CRAs offer top quality monitoring, through agile and flexible processes and transparent communication. We are up to date with all required trainings, and remain abreast of current legislations, techniques, and technologies.

For more information on Altasciences' monitoring capabilities, contact one of our experienced CRA team members.

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