Adversity Level Determination in Nonclinical Studies

This complimentary webinar offers expert insight into how data is interpreted on toxicology studies. More specifically, we provide you with an insider’s view on common practices and guidances followed by contract research organizations to characterize adversity. 

Case studies included:

• Overt toxicity, exaggerated pharmacology, and changes in various markers of toxicity in the context of other safety endpoints
• How to approach data interpretation on toxicology studies to classify adverse vs. non-adverse effects

Watch now

You may also be interested in the following:

• Preclinical Drug Development Solutions
• Podcast — Overcoming Drug Development Pathway Challenges with Dr. Ghatnekar
• Safety Pharmacology Capabilities

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.

Nonclinical and Clinical Research Services — Phase I to IV

Whether you are looking for a full-service solution or a stand-alone offering, Altasciences will help guide you along the way. We are accustomed to managing complex projects with different partners, and have robust communication and operational processes in place to ensure efficient integration.

We offer a range of services for early phase and late phase studies, including:

• Program Management
• Clinical Monitoring
• Scientific Publication Development and Review
• Protocol Development and Medical Writing
• PK/PD Analysis and Interpretation
• Data Management
• Biostatistics and Statistical Analysis
• Support Services for Non-Clinical Studies

Have 5 minutes? You may be interested in this:

• Clinical Trial Services
• Podcast — Choosing the Right CRO for Your Clinical Trial Monitoring
• Blog — Five Things You Need to Know About Partnering with an Integrated CRO/CDMO

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.

Many of you are experiencing significant delays (up to 12 months!) in initiating nonhuman primate (NHP) studies. With Altasciences, the time-to study initiation can be as short as two to three months following contracting, thanks to our steady supply of NHPs.

At Altasciences, we do not rely on a single-source NHP supply chain. We remove the stress of sourcing research animals so that you can start your studies faster, with:

• dedicated and diversified Cynomolgus monkey supply agreements in place to allow for faster start-up timelines
• a continuously maintained and backfilled population of hundreds of naïve NHPs at our preclinical facility 

You can schedule newly contracted NHP studies to start in late Q1 and early Q2 2022 immediately.

Contact us to schedule your NHP studies today.

You may also be interested in the following:

• Podcasts:
  • Consultant Series ― Chat with Dr. John Atkinson, Founder of Atkinson Toxicology Consulting
  • Science, 3Rs, and Animal Welfare with Dr. Megan R. LaFollette from 3RNA
• Fact Sheet: Biologics Safety Assessment Capabilities

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.

Careful planning and financial commitment can make the difference between starting your safety testing studies on time or experiencing significant delays.

Once you have determined your desired safety assessment start date, we recommend taking the following steps to ensure you start your studies on time, and on your terms.

• 12-18 months before: 
  • Schedule a meeting with the FDA to go over your safety assessment plan.

• 9-12 months before: 
  • Get quotations from your preferred CRO partners. 
  • After receiving the proposals, discuss your program with an expert toxicologist to ensure you captured all the required studies.

• 6-12 months before (depending on research animal species and study type):
  • Choose a CRO partner and sign a contract. 

Reach out to us today so we can go over these steps together and ensure your study starts on time.

Our clinical trial experts set your drug development program up for success by proactively preparing and performing each critical moving part while others are underway. As a single source for early phase drug development solutions, we integrate and synchronize key CRO/CDMO activities, such as clinic-ready manufacturing, bioanalysis, clinical study conduct, and regulatory review, so that you’re always ready for the next step.

Check out how we do this and experience the difference.  

You may also be interested in the following:

Webpages:

• Proactive Drug Development
• First-in-Human Trials

Fact Sheet:

• Comprehensive Research Support

Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining 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.

Are you struggling to schedule safety testing with nonhuman primates (NHP)? At Altasciences, we have secured a supply of research animals, making our study start times for NHP studies one to three months faster than industry norms.  

What we do to ensure NHP supply for our clients:

• Keep dedicated and diversified Cynomolgus monkey supply agreements in place to allow for faster start-up timelines
• Continuously maintain and backfill a population of several hundred naïve NHPs at our preclinical facility 

What this means for you:

• Schedule newly contracted NHP studies to start in late Q1 / early Q2 2022

At Altasciences, we do not rely on a single-source NHP supply chain. We remove the stress of sourcing research animals so that you can start your studies faster.

Contact us to schedule your NHP studies today.


You may also be interested in the following:

• Podcasts:
  • Consultant Series ― Chat with Dr. John Atkinson, Founder of Atkinson Toxicology Consulting
  • Science, 3Rs, and Animal Welfare with Dr. Megan R. LaFollette from 3RNA
• Fact Sheet: Biologics Safety Assessment Capabilities

Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining 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.

The potential use of psychedelics for the treatment of various CNS indications is filling the drug development pipeline. Researchers in the field are examining modified chemical structures and analogs to psychedelics, to demonstrate efficacy and mitigate potential side effects.

In this podcast, Altasciences’ and DevelRx’s scientific experts examine the preclinical, clinical, and regulatory requirements and strategies that second-generation psychedelics may utilize to differentiate their pharmacological profile. We examine how to demonstrate efficacy and generate safety data that may distinguish psychedelics from first generation candidates. 

Listen now

Speak with an expert about your research needs.

You may also be interested in the following:

• Blog: Clinical Applications of Hallucinogens, Dissociatives, and other Schedule I Drugs
• Webinar: Navigating Early Phase CNS-Active Drug Development with Dr. Beatrice Setnik, CSO
• The Altascientist: CNS, Hallucinogens, and Other Schedule I Drugs
• Fact Sheet: Central Nervous System Capabilities

Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining 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.