Clinical Trials
Protocol Design Concepts in Phase I Ethnobridging Clinical Trials
In Phase I ethnobridging clinical trials, there are three primary protocol design concepts utilized.
Premier Service Provider for Driving Simulator Clinical Trials
With over 13,000 simulated drives to date and the ability to accommodate up to 20 driving simulators on-site at once, Altasciences is the ideal full-service provider for your driving simulator clinical trials.
You can gather accurate driving performance data comparable in sensitivity to over-the-road testing, with faster study startup, lower cost, no risk of property damage, and no risk of injuries.
When working with Altasciences, you benefit from:
- A large database of study participants for ease of recruitment
- Professional oversight by fullycertified, in-house driving simulation study specialists
- Advanced 3D graphics that generate realistic representations of driving environment
- Automated measurement of psychomotor functioning, divided attention, situational awareness, and other cognitive behaviors
Click here for more in-depth information about our driving simulator capabilities, or contact our experts to discuss.
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept and beyond.
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The Altascientist: FDA Finalizes Drug-Impaired Driving Guidance
Video: Driving Simulation Studies
Fact sheet: Driving Simulation Studies
Clinical Applications of Hallucinogens, Dissociatives and other Schedule I Drugs
Following an initial period of study, mainly in the early 20th century, many hallucinogenic drugs had been dismissed as drugs of abuse with no clinical utility.
Podcast — Altasciences’ Clinical Trial Monitoring
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Altasciences’ clinical trial monitoring solutions will help progress your study from initiation to final close-out efficiently, while saving you time and costs. Our team of highly experienced, well-trained CRAs, will work with you throughout the conduct of your clinical trial to ensure strict adherence to protocol and regulations, subject safety, and accurate visit reporting. Learn more about the benefits of working with Altasciences’ CRAs for your clinical trial monitoring needs. |
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Video — A Seamless CRO Experience
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At Altasciences, our integrated, full-service solutions from lead candidate selection to clinical proof of concept are all customizable to your specific needs. Watch as Ingrid Holmes, Vice President, Global Clinical Operations, discusses how we help sponsors bring better drugs to market, faster. |
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Contact our experts to learn more about our integrated drug development solutions. |
Identifying Appropriate Outcome Measures and Methodology to Evaluate the Abuse, Misuse, Dependence, and Impairing Effects of CNS-Active Drugs in Healthy Volunteer and Patient Trials
Data that Meets Regulatory Guidelines Worldwide
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Robust planning early in drug development can save you both time and money. Altasciences' in-house pharmacokineticists and biostatisticians can work with you to build a robust strategy from the get-go. They are accustomed to managing complex projects with different partners, no matter the therapeutic area — your drug will be in expert hands. | |
A Look at Driving Simulation Clinical Trials
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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. |
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Participant Retention Strategies in Phase I Clinical Trials
In this article, we explore key participant retention strategies in Phase I clinical trials.
First-In-Human and Proof-of-Concept Trials
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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. |
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