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.

Unique FIH Solutions for Small and Large Molecules

Advancing your molecule to first-in-human (FIH) clinical trials is a major milestone. Our FIH solution provides a customized approach that is safe, and delivers quality data with speed and ease.  

Access the e-book here to learn more.

Download

This e-book provides an overview of how our unique process can facilitate your early phase clinical program:

• Small molecule manufacturing experts quickly formulating your drug product and delivering it to the clinical site, ready for dosing. 
• Coordinated processes running between the clinic and the bioanalytical lab. 
• Timed interim sample analysis for proactive dose escalation decisions and rapid turnaround of PK/PD analysis between cohorts. 
• Transparent communication between teams and locations, and strict attention to early phase timelines.  
• Delivery of high-quality data utilizing our database of over 400,000 normal healthy volunteers and strict safety protocols.

Speak with one of our experts.

You may also be interested in the following:

Webpages:

• Phase 1 Clinical Trial Units 
• First-in-Human Trial Capabilities
• CNS Clinical Trial 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.

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.

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.