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

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.

With extensive expertise in a wide range of study types and therapeutic areas, Altasciences’ clinical monitoring and site management teams deliver reliable data, fast. Our experts work closely with you and your sites, to guide you through the complex steps of drug development.

Clinical Monitoring:

Highly skilled clinical research associates oversee all aspects of your clinical trial conduct to ensure data integrity, patient safety, protocol compliance, and GCP.

Site Management:

Experienced project managers oversee the conduct of multi-site programs in close collaboration with key internal and external stakeholders, ensuring seamless and timely communication.

Whether as stand-alone or part of an integrated program, let’s discuss your clinical monitoring and site management requirements today.

Speak with an expert

Have 5 minutes? You may be interested in:

• Impaired Renal and Hepatic Function Trials Capabilities
• Full-Time Equivalent Capabilities
• Research Support Services Capabilities
• Integrated Drug Development Services

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.

CNS Center of Excellence

Are you working on a CNS-active drug? With over 25 years of conducting preclinical and clinical studies, Altasciences’ CNS Center of Excellence experts have developed an extensive resource library, including webinars and scientific journals, to guide you through all phases of early drug development, from lead candidate selection to clinical proof of concept, and beyond.

Ensure a Smooth Transition from Formulation to Clinical Trials

Altasciences supports your formulation and drug development needs for preclinical safety testing, from discovery through first-in-human (FIH) clinical trials, for all dosage forms, such as oral liquids, powders, capsules, and injectables.

Our integrated approach combines formulation development, cGMP manufacturing and release testing, as well as clinical testing functions/workflows. One of the biggest benefits of this seamless offering is that our clinical trial teams work closely with the scientists involved in the formulation and manufacturing process, and are able to evaluate and optimize new formulations in the clinic, based on real-time human data. This collaboration and data sharing between our teams leads to shorter timelines, less risk, reduced costs, and improved flexibility.

Learn more about our expertise with both simple and complex formulation development, including those with highly potent APIs and solubility/bioavailability challenges. 

Questions? Speak with one of our experts.

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.

Opioid medications offer important benefits for pain management. They also have significant risks for abuse, dependency, and cognitive impacts. At Altasciences, we have leading-edge expertise in the scientific and clinical aspects of human abuse potential (HAP) evaluation, dependency assessment, and cognitive testing. We also devote significant time and resources to understanding the human behavioral elements of drug use, from recreational to abuse.

View the podcast series that takes a deeper look at the users behind the behavior, moderated by Dr. Beatrice Setnik, Chief Scientific Officer, and featuring Dr. Debra Kelsh, Psychiatrist and Principal Investigator at Altasciences:

• Trailer—The Many Face of Recreational Drug Use
• Episode 1—Introduction and interview with male, 30, opioid user
• Episode 2—Brief introduction and interview with female, 46, opioid use disorder
• Episode 3—Brief introduction and interview with male, 24, recreational poly-drug user

We seek to understand the genesis of the human story so that we can better influence the evolution, applying our expertise in opioid trials including HAP evaluation, driving simulation, abuse-deterrent formulations, and more, to this complex issue.

Exploring Altasciences' Expertise in CNS Drug Development

You won't want to miss this 5-minute Quick Chat video!

Dr. Denise Milovan explains how Altascience's expertise in pharmacodynamic assessments for CNS drug development benefits both sponsors and study participants.

Altasciences has the specialized facilities and highly trained experts to conduct a comprehensive battery of assessments, including:

• Visual analog scales
• Cognitive measure of attention, memory, etc.
• Drug liking
• Pain perception
• Sense distortion

Watch Now (5 minutes)

Our Altascientists can provide a thorough understanding of the cognitive impacts of your CNS-active drug. Contact us today.

Have a few more minutes? Check these out:

• The Altascientist—CNS Drug Development
• Fact Sheet—CNS Drug Development
• Webinar—Inside the Pharmacodynamic Toolbox