We provide the infrastructure, technologies, and expertise required to execute early phase patient studies around the world.
Today, there is an increased interest in having patient safety and efficacy data available as early as possible during the clinical pharmacology program. PRA’s innovative Early Patient Solutions (EPS) provides a lean proof-of-concept model designed to evaluate clinical endpoints and biomarkers within a smaller sample size of patients to provide earlier data for go/no go decisions.
Early patient trials require a special approach due to multi-site setup for patient access, patient confinement for safety monitoring, intensive procedures and PK sampling, urgent timelines for data and results, multi-stage dose escalation studies and adaptive protocols, and a cost-effective approach.
EPS provides an end-to-end solution perfectly suited for these trials. Leveraging PRA’s range of specialized therapeutic, operational, and drug development expertise, along with global resources, we develop customized solutions to help clients achieve their key milestones. Drug developers are making the critical decision of whether or not to proceed, and EPS offers a solution with reduced time and cost from the drug development timeline.
State-of-the-art Clinical Facilities
We provide end-to-end bioanalytical support from Pre-clinical to Phase IV studies. At PRA, our laboratories are managed, staffed, and supported by…
Bioanalysis, Biomarker and Flow Cytometry Assay List
Bioanalysis, Biomarker and Flow Cytometry Assay List. PRA Laboratories—Solutions for Drug Development. Behind every sample waiting to be analyzed,…
Progressive healthcare for patients across a wide range of indications.
We are committed to providing our patients with the most comfortable and progressive healthcare, while we continue to search for innovative solutions to their unique conditions.
Our expertise includes:
ADME Studies in Oncology Patients
Our ADME study objectives include assessing absorption and distribution, elucidating the routes (metabolism) and the rates of excretion (elimination), assessing the mass-balance and the metabolite profile, and identification. We suggest conducting 14C studies early in development to help identify metabolites early, to determine the necessity of additional pre-clinical trials, to define the patient population, and to design later trials more effectively.
Our sites have access to 1.5 Tesla MRIs, SMRIs, and Pet scans for ease of protocol requirements, and our Salt Lake City site has a close working relationship with the local Alzheimer’s Association, providing us maximum exposure within the local community and greatly helping with recruitment. Currently, we have over 1,500 Alzheimer’s subjects in our database, have successfully conducted over 34 studies, and have randomized over 100 subjects.
Central Nervous System (CNS)
As a leader in CNS clinical research, we’ve conducted more than 200 early phase CNS studies. We provide our partners with dedicated project teams, access to early phase sites with established pain and psychiatry investigators and specialization in addiction studies, expert consultation on the use of screening and efficacy scales for CNS disorders, including patient-reported outcomes (PROs), and a medical monitoring team of experienced neurologists and psychiatrists.
We collect pristine and reproducible data that contributes to the development of safer and more effective treatments for adult, adolescent, and pediatric diabetes and related metabolic and endocrine disorders. We have successfully conducted over 50 studies and have an extensive database which includes over 9,000 diabetes subjects.
With rapid access to over 6,900 Hepatitis C subjects, 75% being treatment naïve, we can recruit efficiently for this special population. Our investigators are experts at conducting clinical trials in the HCV population, including first-in-population, single-ascending dose (SAD), and multiple-ascending dose (MAD). In over 30 successful trials, we quickly screened over 600 subjects and have a proven history of leading enrollment and retention.
Our team of Board-Certified Psychiatrists and Child Psychologists works closely with parents and their children to educate and treat the entire family. Our expertise includes attention-deficit/hyperactivity disorder (ADHD), mood disorders, anxiety disorders, psychotic disorders, major depressive disorder (MDD), migraines/headaches, oppositional defiant disorder (ODD), social phobia, diabetes, Tourette’s and tic disorders, autism spectrum disorders, and Phase I pediatric study challenges.
Human Abuse Potential and Liability (HAP)
We’ve successfully completed more Human Abuse Potential and Liability (HAP/HAL) protocols & published more HAP studies than any other CRO.
Phase I healthy volunteer studies play a vital role in clinical research by providing researchers with the knowledge they need to make educated…
Early Phase Solutions
We understand the need to maximize success while minimizing time and costs. That’s why we strategically positioned our laboratories within close…