A Chat with Dr. Kelsh, Sr. Principal Investigator

In the past decade alone, Altasciences has conducted 50+ human abuse potential, abuse-deterrent formulation, or substance abuse studies, including through repeated multi-year clinical research contracts with the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA).

Watch as Dr. Kelsh, Senior Principal Investigator at our Kansas City clinical facility, discusses why Altasciences is a leader in the conduct of human abuse liability trials.

Want to know more? Speak with an expert about your CNS clinical research needs.

You may also be interested in the following:

Webpages: 

• Human Abuse Potential
• CNS Clinical Trials 
• Altasciences’ State-of-the-art Clinical Trial Facilities

Webinar: Navigating the Abuse Potential Evaluation of CNS-Active Drugs for EU and U.S. Submissions

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.

From discovery to preclinical to Phase IV, Altasciences’ bioanalytical team of over 260 scientific experts specialized in bioanalysis, ligand binding assays (LBA), mass spectrometry, immunology, biomarkers, flow cytometry, and PCR, operates in three strategic locations in proximity to our preclinical and clinical sites. We aim to provide top quality data for TK, PK, and PD determinations to support your preclinical and clinical studies.   

At Altasciences, One Laboratory Sciences moves in unison for the success and acceleration of drug development.

Let’s schedule time to discuss your bioanalytical needs.


You may also be interested in the following:

• Podcast — Three Laboratories - One Vision, with Dr. Lynne Le Sauteur
• Webinar — Managing Challenging Bioanalysis for PK/PD Assessments for Phase I Biologics
• Video — Take a Look Inside our PCR Lab
• Press Release — Altasciences Expands Ligand Binding Laboratory to Meet High Demand for Bioanalytical Solutions

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.