HAP Capabilities at Our Kansas City Clinical Facility

Altasciences is a CNS Center of Excellence for research from discovery to preclinical to clinical. We have experience in a diverse range of human abuse potential (HAP) studies, such as for stimulants, opioids, and sedative hypnotics; and have conducted over 60 HAP trials over the last decade. 

Sponsors choose our Kansas City Research Campus for their HAP studies for our:

• Experienced physicians who understand how to work with recreational drug users
• 36-bed specialty clinical unit in Kansas City for sequestering patient populations
• Upscale facilities that contribute to industry-leading retention rates for up to 60 days of consecutive confinement
• Pharmacies with USP 797 clean room with Class II biological safety cabinet
• Database of over 400,000 active participants including 45,000 at our Kansas City site alone.  The database includes recreational abusers of opioids, stimulants, sedative hypnotics, and cannabinoids

Discover more!


You may also be interested in the following:

• Webpages:
  • CNS Clinical Trial Capabilities
  • Human Abuse Potential Capabilities
  • Our Early Phase Clinical Facilities
• Video:
  • Quick Chat with Dr. Kelsh — Leader in CNS and Human Abuse Liability Studies

Join our upcoming webinars:

• Inside the Pharmacodynamic Toolbox: How Questionnaires, Models, and Tests of Cognition Can Accelerate the Development of CNS-Active Drugs
• Ethnobridging in Phase I Clinical Trials: Strategy for Enhancing Asset Value and Accelerating Global 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.

Altasciences’ Clinical Facilities Move in Unison

Altasciences provides strategically located clinical pharmacology facilities and access to over 500 beds across North America. We have over 1,000 employees dedicated to clinical pharmacology research who conduct over 285 trials per year. 

Operations at our clinical teams in Los Angeles, Kansas City, and Montreal follow the same set of standard operating procedures to offer you a scientifically sound, quality experience, every time — for both your single-site or multi-site studies.  

In addition, our clinical teams work in unison with our preclinical, bioanalytical, manufacturing, and research support teams at our five other sites, to offer an integrated drug development solution, from lead candidate selection to clinical proof of concept, and beyond.

Altasciences provides customized solutions that fit your needs, and innovative in-house recruitment call centers for quick study startup.

Let’s get started!

You may also be interested in the following:

• Video: Fully Integrated Drug Development Solutions
• Webpage: Phase 1 Clinical Trial Units 
• E-book: First-in-Human Solution 

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.

Episode 2 — The Many Faces of Recreational Drug Use 

Prescription drug abuse has been an ongoing public health concern in North America.  In this second episode of "Chasing the Dragon — A Series of Candid Interviews with Opioid and Stimulant Recreational Drug Users”, you will hear from an individual who began using opioids following a back injury. Then, Altasciences’ Dr. Beatrice Setnik, CSO, and Dr. Debra Kelsh, Psychiatrist and Principal Investigator, provide a unique perspective around the behaviors of drug abuse. 

See the second episode: 

In case you missed it, watch Episode 1 here.

Speak with an expert about your research needs.

You may also be interested in the following:

• The Altascientist: CNS-Active Drugs — Complex Considerations
• Webpage: Human Abuse Potential Capabilities
• E-book: First-In-Human Solution

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.

NDA-Enabling Studies

The development of an NDA submission plan can sometimes be unclear. Partnering with the right CRO early on can increase your chances of success and ensure you meet your milestones. With over 25 years of experiences, Altasciences' specialists apply their knowledge in designing, conducting, analyzing, and reporting on trials for regulatory submissions, across the spectrum of therapeutic areas. 

Our complimentary fact sheet guides you through the different study types and features of NDA-enabling clinical pharmacology studies, and how we can support you.

Download fact sheet now

Want to learn more about some of the requirements for each study? Click on the links below: 

• Proof-of-Concept in Special Populations
• Renal and Hepatic Impairment
• Drug-Drug Interaction
• Thorough QT
• Human Abuse Liability or Potential
• Cognitive Assessment Driving Simulation
• Elderly

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.

Highlights of Our Kansas City Research Campus

Altasciences’ clinical facilities are dedicated to the conduct of early phase and clinical pharmacology trials in a wide range of therapeutic areas. Our Kansas City clinical facility works in unison with our 6 other sites to offer an integrated drug development solution from lead candidate selection to clinical proof of concept and beyond. With over 25 years of experience, conducting 285+ trials annually, our clinics are flexible and adaptable for single or multi-site clinical trials. 

Our Kansas City purpose-built clinic features:

• 140 beds
• On-site USP 797 certified pharmacy 
• 36-bed specialty clinical unit for sequestering patient populations
• Upscale facility with accommodations that ensures best recruitment and retention
• Dedicated QT unit 
• Principal Investigators with psychiatry and epidemiology specializations
• Neuro/CNS specialization — over 40 Human Abuse Potential (HAP) studies conducted
• Full-service capabilities including bio analysis, manufacturing, designing, conducting, and reporting on clinical pharmacology studies required for regulatory submission.

Virtually step inside our KC clinic here.

You may also be interested in the following:

Webpages:

• Our Clinical Trial Facilities
• CNS Clinical Trial Capabilities

Video: Quick Chat with Dr. Kelsh — Leader in CNS and Human Abuse Liability Studies

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.

Combining Trial Conduct and Bioanalysis for Success

Combining Phase I trial conduct of biologics and bioanalysis is critical for successful drug development. Clinical development relies heavily on bioanalytical experts to generate critical data to understand pharmacokinetics and pharmacodynamics. 

Here are just some of the benefits of working with Altasciences:

• Timed interim sample analysis for dose escalation decisions
• Rapid turnaround of PK/PD analysis between cohorts 
• Biomarker development and validation for exploratory or primary endpoints
• Proximity flow cytometry 
• Centralized scheduling between clinic and lab
• Ability to easily switch or combine platforms which are sensitive, have high throughput, and demonstrate exquisite specificity

Watch this complimentary webinar to see how you can overcome challenges throughout all phases of drug development.

Watch webinar

Have 5 minutes? Take a look at these:

• How Is Partnering with Altasciences for Your First-in-Human Clinical Trials Different?
• Microsampling in Drug Development
• Validated Bioanalytical Assay List

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.

Multi-Site Clinical Trial Management and Monitoring

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.

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.