We have decades of first in human trial experience, designing, conducting, analyzing, and reporting on FIH studies for small molecules and biologics, and we offer the opportunity to begin the regulatory process in either the U.S. or Canada. Our clinical pharmacologists are proficient at designing NDA-enabling studies, including single and multiple ascending dose studies, as well as testing for various effects, such as age, gender, and food. Our first in human trials routinely include assessments of biomarkers or symptom assessments to establish proof of concept. Our toxicologists provide support in calculating starting doses, and work with our clinicians in determining the best Phase I clinical trial monitoring practices for effects observed during preclinical trials.

Our clinics have purpose-built units that offer the stringent patient oversight required to safely perform ascending dose studies required. Before starting each FIH study, our clinical teams perform a risk assessment to ensure we are appropriately staffed and resourced to ensure participant safety for your critical FIH trials.

We have the recruiting experience and capacity to quickly fill FIH study cohorts that are dosed weekly, and can add patient cohorts or conduct entire studies in patients, as needed.

Consult our FIH Fact Sheet.

Altasciences has conducted over 50 human abuse potential (HAP), abuse deterrent formulation (ADF), or substance abuse studies since 2008, including through repeated multi-year contracts with the NIH and the FDA. HAP studies may be required by the FDA as part of the safety evaluation for New Chemical Entities (NCEs) that are CNS-active, chemically or pharmacologically similar to other drugs with known abuse potential, or produce psychoactive effects such as sedation or euphoria. ADF trials are often pursuant to a 505(b)(2) or Hybrid strategy. The complicated regulatory pathway for HAP and ADF protocol designs (selection of comparator, recruiting, etc.) requires individualized consulting for each type of study.

Our physicians work with both recreational drug users and substance-dependent participants, and have significant expertise in the identification of appropriate subjects for substance abuse studies. We have the specialized pharmacy facilities and locations to ensure appropriate manipulation of many abuse-deterrent formulations.

Our clinical sites have robust databases of recreational abusers of opioids, stimulants, sedative hypnotics and cannabinoids, including abuse by oral, parenteral or nasal routes. Our upscale facilities contribute to industry-leading retention rates for up to 60 days of consecutive confinement.

Altasciences’ adaptive clinical pharmacology unit in Kansas City provides a highly reconfigurable and adaptable space for conducting complex clinical trials with challenging subject populations. The 30-bed locked, limited-access, self-contained unit allows sponsors to control every aspect of the study environment as it relates to the special needs of the unique study population or the specific requirements of the protocol, and makes it possible for them to obtain key efficacy data earlier in their development process.

We partner with Cambridge Cognition for VAS scale collection for pharmacodynamic measures, such as drug liking. Our experienced clinical staff is retrained on use of the tablet-based software before each study. We also educate participants on system use and relevant details, such as the difference between unipolar and bipolar scales. We ensure there is a 1:1 staff to participant ratio during the collection of this vital data.

View webinar - Cracking the Pill: A Journey of Exploring Abuse-Deterrent Methods from Laboratory, to the Clinic, the to Real User.

Consult our Human Abuse Fact Sheet for innovator medications
Consult our Human Abuse Fact Sheet for generic medications

With the finalization of the FDA guidance in 2017, driving simulation studies are now required for any drug that may affect cognition. Driving simulation studies are the ideal way to collect data required for the drug label when pre- and early clinical studies show that a drug may cause somnolence or impair cognition. Our experts can design and conduct driving simulation studies to efficiently determine the extent and duration of driving ability impairment.

At Altasciences, we design driving studies to achieve your objectives, leveraging extensive experience across clinical testing of cognitive effects. We partner with Cognitive Research Corporation to use their proprietary driving simulators, nine of which are permanently installed in our clinic. We have performed well over 10,000 simulated drives to date, analyzing the impairment seen at peak exposure and/or the effect seen the morning after evening dosing.

We have a suite of ten simulators on site at our clinical facilities, with space for more than 20 additional, as needed. Professional oversight is provided by fully-certified, in-house driving simulation study specialists.

Consult our general Driving Simulation Fact Sheet

Our comprehensive, integrated proof of concept (POC) study services help you achieve your critical milestones faster. Our experts in the design and conduct of phase I clinical trials will deliver your clinical research efficiently, effectively, and on time. With the research support of regulatory experts, bioanalytical scientists, experienced biostatisticians and medical writing teams, you can trust Altasciences with your POC studies. Proof-of-concept studies present unique challenges in both design and conduct. Working with a CRO skilled in both is vital for the success of your Phase I clinical trial program. Altasciences has designed and conducted a wide range of FIH and stand-alone proof of concept clinical trials.

Consult our NDA-Enabling Fact Sheet

Proof of Concept (POC) Study Conduct Expertise

Our clinical pharmacologists perform background research, and consult with research specialists, to ensure we craft the ideal design to meet your objectives, including collaborating with our preclinical colleagues to select the models or biomarkers that translate from preclinical to clinical. Our clinical trial teams capture the endpoints in a consistent manner, training our staff to administer both objective and subjective proof of concept study tests in the exact same way. We also carefully educate participants in what is expected of them during a Phase I clinical trial.

We routinely perform POC clinical research in healthy participants, and leverage our access to a wide range of patient populations for indications that do not have models appropriate in healthy participants. Prior to starting a proof of concept study, our recruiting department produces an accurate estimate of recruitment numbers and timelines. For some indications, we can recruit a large number of patients (i.e., more than 50 patients in areas like diabetes, obesity, and osteoarthritis), while in others, we conduct POC research with smaller groups.