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. Four of our eight clinical pharmacology centers are 100% dedicated to early phase patient studies in both Europe and the US so that we can fully support our clients’ needs in this area.
Our innovative Patient Pharmacology Services (PPS) group performs early patient trials in collaboration with our extensive network of investigators throughout Central Eastern Europe, including Hungary, Poland, Czech Republic, and Slovakia. In the US, our clinical research centers specialize in the conduct and design of early stage, patient population studies, and are therapeutically focused in human abuse liability (HAL), addiction, pain, psychiatry, neurology, pediatric, and infectious disease services.
Our comprehensive areas of expertise range from a 16 DMII-patient panel in a multi-purpose protocol, early Proof of Concept, and highly complex patient trials such as Renal/Hepatic impaired trials to ADME studies in oncology patients and children with Tourette’s Syndrome.
Global leaders in early phase psychiatric studies.
Our team is recognized worldwide as a leader among researchers in the field of psychiatry, with trial solutions spanning all psychiatric indications. We’ve completed more than 35 Phase I psychiatric trials and 150 inpatient trials.
We’ve successfully conducted over 250 trials, randomizing over 600 subjects for anxiety disorders such as post-traumatic stress disorder (PTSD), obsessive-compulsive disorder, panic disorder, social phobia, and generalized anxiety disorder.
With a robust database of over 6,000 schizophrenia subjects, we have conducted over 200 studies for this chronic brain disorder.
Our US sites have an extensive database of over 23,000 subjects who suffer from depression, and we’ve conducted over 175 studies, randomizing over 800 subjects. 35% of our database consists of treatment-resistant subjects, which allows us to recruit for even the most challenging trials.
Our US sites offer:
300+ bed capacity in Salt Lake City and Lenexa
20,000+ subject database in anxiety, bipolar disease, ADHD
Industry leaders in long-term subject retention
Experts in psychiatric rating scales, rater training, and cognitive testing
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.
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…
Phase I healthy volunteer studies play a vital role in clinical research by providing researchers with the knowledge they need to make educated…