In this latest issue of The Altascientist, we guide you through the complex, multi-step data journey for Phase I clinical trials, from study conceptualization and protocol development, to data collection and analysis, through to final regulatory submission. We highlight best practices and approaches to mitigate challenges, and show how integration and collaboration build the strongest datasets for your drug development program.

Speak with an expert to learn more about our service offering.

Have a few more minutes? Check out these insightful resources:

• The Altascientist—CDISC Data Standards
• Fact Sheet—Comprehensive Research Support
• Blog—Data Management Excellence

Driving simulator studies are a safe, efficient, and effective alternative to on-the-road driving trials for CNS-active drugs. This issue of The Altascientist dives into the requirements and technicalities of driving studies, and explains how driving simulation offer:

Faster study startup • Lower cost • No risk of property damage • No risk of injuries

This issue includes a case study for which the results were described as “reassuring” by the FDA.

Altasciences has conducted over 13,000 simulated drives in support of drug development.

Download as a PDF or listen to the audiobook, the choice is yours.

You may also be interested in the following:

• Driving Studies Webpage
• Driving Studies Video

Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services.

In this issue of The Altascientist, we cover the innovative progress we have recently seen in mass spectrometry, and how the advancements of science and technology can help you achieve critical milestones in your early phase drug development study or program.

In this issue you will explore:

• The case for stable isotope labelled internal standards for LC-MS quantitation
• Recent innovations in mass spectrometry
• Six case studies

You may also be interested in the following:

WRIB 2022 Poster Presentation: Development of Surrogate CSF for Quantitative Analysis of ASOs by Hybridization LC-MS/MS

Webinars:

• Panel Discussion—Automation in the Bioanalytical Laboratory
• Selectivity, Selectivity, Selectivity—A New Dimension by Differential Mobility Spectrometry

Podcast: Microsampling: When Small Steps Lead to Big Outcomes

Your Formulations, Brewed to Perfection.

Pharmaceutical formulation is one of the most critical steps in early phase drug development. The successful formulation of your active pharmaceutical ingredient (API) will ensure a smooth transition to preclinical testing and clinical trials, and eventually to market.

Our experts have vast experience formulating both simple and complex formulations, using techniques such as nanomilling to successfully formulate even the most challenging, insoluble, or highly potent APIs―ensuring you have your preclinical and clinical study material on time.

Here's a glimpse of our scientists working their magic!

Do you have an API that needs to be formulated? Contact us to get started.

Related Resources:

• Interview: Complex and Customized Formulation Development
• Webpage: Contract Manufacturing and Analytical Solutions
• Case Study: Rapid Development of a Cannabidiol Formulation

Altasciences has extensive experience conducting early phase clinical trials for ophthalmic products targeting numerous eye diseases and disorders, such as open angle glaucoma, ocular hypertension, and dry eye.   

Our clinical solution includes:

• In-house ophthalmologist with over 20 years of experience
• Three North American inpatient units from coast to coast with over 500 beds — fully equipped inpatient and outpatient capabilities
• Robust network of ophthalmology sites in close proximity to our clinics to conduct studies on both the front and back of the eyes
• Database of over 400K participants for healthy normal and patient recruitment

Book a consult with one of our experts to learn more about our solution and how we can support your program. 

You may also be interested in the following:

• Fact Sheet: Ophthalmology Clinical Research Services
• Webpage: Comprehensive Solutions for Ophthalmic Drug Development
• The Altascientist—A scientific journal: The Complexities of Early Phase Ophthalmic Drug Development

Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for 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.