Altasciences has over 10 years’ experience in cannabis studies, conducting nearly 40 studies on different cannabis products, cannabinoids, or with cannabis users. We are also at the forefront of comparing vaping devices to combustible products, both for pharmacokinetics and exposure to potential harmful biomarkers. Our studies meet current FDA regulations for tobacco products.

We have extensive experience with all routes of administration:

• Combustible
• Vaping
• Tablets
• Oils
• Sublingual
• Topical gels

We have worked with whole plant extracts and isolated phytocannabinoids or fully synthetic cannabinoids. Our bioanalytical laboratory has validated methods for THC, CBD, and three other cannabinoids.

We also routinely assess drug-liking as well as psychoactive and cognitive effects of cannabis or cannabinoid formulations.

Consult our general Cannabis Fact Sheet

Our integrated preclinical to early clinical offering covers recombinant proteins, monoclonal antibodies, oligonucleotides, vaccines, and other therapies. We have extensive experience in study design and PK/PD analysis of novel biologics and biosimilars in preclinical and clinical settings.

Our bioanalytical team analyzes biologics by LC-MS/MS and ligand binding, starting in animal matrices and moving to human. We measure anti-drug antibodies generated and determine if they are neutralizing using competitive binding or functional assays.

Our purpose-built clinics provide the close oversight required for treatment with novel biologics and biosimilars, and offer a high level of safety as well as comfort to participants for efficient recruitment and long-term retention.

We design, conduct, analyze, and report our studies in-house, drawing on our regulatory consultants, our experts in clinical conduct on biologics, and our biostatisticians, data managers, and medical writers with relevant experience in biologics and biosimilars.

Looking to conduct a study? View this list of biosimilars and contact us to discuss further.

Case Studies

• Assessment of the IonKey/MSTM Technology to Reach Ultra High Level of Sensitivity for Bioanalysis Quantification of Large Molecules in Plasma
• Application of Complementary HRMS Methodologies for a Thorough Biosimilar Comparability Assessment
• Application and Advantages of HRMS in the Quantification of Therapeutic Monoclonal Antibodies: “The Rituximab Case Study”
• PPIP Extraction to Resolve Specificity and Sensitivity Issues: Bioanalysis of a PEGylated Human Protein Analog
• Quantitative Bioanalysis of Rituximab and Reditux for Biosimilarity Assessment: Comparing Triple Quadrupole and Hybrid Time-of-Flight Platforms

Consult our general Biologics/Biosimilars Fact Sheet

Altasciences has performed well over 20 studies requiring different imaging modalities. Our sites have access to X-ray, CT, MRI, ultrasound and DEXA scanners at radiology clinics, and endoscopy and colonoscopy through gastroenterology clinics. Our partners’ facilities are in the same building as our clinics, or within a few minutes’ drive.

The imaging is conducted to validate inclusion/exclusion criteria as pharmacodynamic measures, or to guide injections by ultrasound. Regardless of the objective, we ensure that the imaging process is designed to meet your study requirements, including working with radiology clinics approved by central imaging providers to review the procedures and validate test images as required.

We have designed, conducted, analyzed, and reported on a large number of renal and hepatic impaired studies in recent years, across the spectrum of therapeutic areas. We partner with leading external sites to ensure that our renal and hepatic impaired patients have the specialized clinical oversight they need, and we leverage their databases to ensure we access the patient populations you need.

For renal impaired studies, we partner with Hôpital Maisonneuve-Rosemont (HMR), located near our Montreal clinic. HMR recruits and treats the severely and moderately impaired groups, and the Altasciences clinic completes with the mildly impaired and healthy matches. We have used this approach for more than 10 studies and usually conduct the clinical trial in less than three months.

For hepatic impaired studies, we work with leading sites in the U.S. and Canada. Depending on the need to include severely impaired patients, and the full inclusion/exclusion criteria, we conduct the studies with two to five sites. Our Project Managers simplify the multi-site process by providing one point of contact, and ensuring recruitment proceeds according to plan.

Consult our Renal and Hepatic Impaired Fact Sheet
Consult our Renal Impaired Fact Sheet

We work with you to determine the ideal approach for measuring the QT prolongation effect of your new compound or formulation by partnering with core ECG labs for the data collection and analysis.

Some sponsors choose to add early cardiac safety assessment to their first-in-human studies, while others wait for later development and perform a Thorough QT prolongation study. Regardless of your approach, Altasciences can help you with the design. We have conducted 11 studies involving cardiac Intense/concentration QT/TQT (IQT/TQT) since 2016.

The design and conduct of studies focused on ECG measurement revolve around reducing variability in the measures, as this allows the studies to be conducted with smaller sample sizes. We consider the impact of clinical events like blood draws, and also limit other stimuli. We ensure that when the ECGs are taken, there are no events that affect heart rate.

Consult our Cardiac Assessment Fact Sheet

Drug-drug and drug-alcohol interaction studies range from simple two-way crossover studies to complex, multi-cohort, adaptive designs. Altasciences has designed, conducted, analyzed, and reported on hundreds of these studies — from the simplest to the most complex.

Our pharmacokineticists review the investigator brochure to determine the studies required, and the ideal inhibitor, inducer, or substrate to use. Our bioanalytical department has validated methods, and we have clinical experience, with almost all common substrates. Our designs are based on literature and in-house experience.

We have conducted single interaction, multiple interactions across cohorts, or multiple interactions within a cohort (cocktail) studies. We routinely perform CYP genotypic to exclude subjects or stratify the groupings.

Consult our general DDI Fact Sheet

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