COMPREHENSIVE CLINICAL TRIAL SERVICES
Our experts in clinical pharmacology research provide guidance, and ensure the design and conduct of your trials leverage preclinical data to successfully move your lead candidates to clinical proof of concept. We have expertise in clinical pharmacology studies for regulatory submissions, in many of therapeutic areas, for small molecules and biologics.
Altasciences’ comprehensive clinical research service offering covers all the clinical pharmacology studies required for regulatory submissions across a wide range of therapeutic areas. With 25+ years of experience in clinical research services, we conduct trials in state-of-the-art facilities in the U.S. and Canada, with over 500 beds and a database of more than 400,000 participants (healthy normal and patient populations). Regardless of participant type or length of stay, we can provide quick start-up times. Our recruitment and retention rates are excellent, with 95% panels filled on time, year after year.
Under one operational structure, and with a dedicated single Program Manager for each project, Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions to offer an integrated/synchronized approach to CRO and CDMO services. From lead candidate selection to clinical Phase II, we integrate bioanalytical assay development and validation, nonclinical safety evaluation, formulation development, clinic-ready manufacturing, on-demand clinical pharmacy, and clinical testing to proof of concept.
Consult our Fact Sheet, watch our video or visit our Resource Library.
CLINICAL SERVICES
Our clinical services include expertise in:
- First in human: Single ascending dose (SAD) and multiple ascending dose (MAD)
- Proof of concept
- PK in special populations
- Drug-drug interaction (DDI)
- Bridging studies
- Comparative bioavailability and PK studies
- Bioavailability (BA) and bioequivalence (BE)
- 505(b)(2)/Hybrid
Specialties include, but are not limited to:
- Biologics and biosimilars
- Infectious diseases
- Human abuse potential (HAP) with new chemical entities and abuse-deterrent formulations (ADF)
- Substance use disorders
- Metabolism and endocrinology
- NAFLD/NASH
- Type I and II diabetes
- Obesity
- Renal and hepatic impairment
- Pain models and inflammation
- Topical vasoconstrictor and irritation‑sensitization
- Cognitive testing
- Driving simulation
- Imaging
- QT assessment
- Smoking and vaping
- Cannabis
Comprehensive Full-Service Offering
Available as stand-alone services, or as part of a development package:
PARTICIPANT RELATIONSHIP MANAGEMENT
We have a database of over 400,000 participants, and systems in place that effectively match study requirements to participant medical profiles. We offer rapid recruitment and study start-up while ensuring participant retention throughout the trial.
- Full-time, in-house recruiting staff
- Screening facilities with direct access to public transportation
- Proactive and study-focused recruitment strategies using multiple media channels
- Extensive screening histories for effective recruitment
- Facilities designed for optimum recruitment and retention
- Proven ability to meet recruitment milestones
CLINICAL TRIAL POPULATIONS
Participant and Special Populations
- Healthy normal volunteers (HNVs)
- Elderly
- Overweight and obese
- Pediatric and adolescent
- Post-menopausal women
- Substance abusers and recreational drug users
- Smokers
Patient Populations
- Allergy
- Asthma
- ADHD
- Atopic dermatitis
- Anxiety disorders
- Binge eating disorder
- COPD
- Constipation
- Diabetes
- Dyslipidemia
- Epilepsy
- Fibromyalgia
- GERD
- Gout
- Glaucoma
- Hepatitis
- Hypercholesterolemia
- Hypertension
- Lupus
- Major depressive disorder
- Migraine
- Osteoarthritis
- Osteopenia
- Overactive bladder
- Pain and inflammation
- Panic disorder
- Premenstrual dysphoric disorder
- Psoriasis
- Restless legs syndrome
- Sleep disorders
- Others upon request
RESOURCE LIBRARY
- Webinar: Demystifying the Conduct of Clinical Trials in Canada presented by Dr. Beatrice Setnik, Chief Scientific Officer and Paul Sidney, Senior Director, Compliance and Regulatory Affairs
- Webinar: Assessing Cognition and Driving Ability: Examining Simple and Cognitive Domains in Clinical Pharmacology Studies presented by Gary G. Kay, Ph.D., President, Cognitive Research Corporation and Ingrid Holmes, Vice President, Global Clinical Operations
- Webinar: Overcoming the Challenges of Manufacturing and Clinical Trials presented by Ben W. Reed, BS, Vice President, Manufacturing; Kevin Kirkcaldy, B.Pharm., MBA, Pharm.D., Pharmacy Manager; Dennis A. DiBiagio, BS, RPH, Vice President, Business Development; Todd Janssen, RPH, Pharmacy Director; and Ingrid Holmes, Vice President, Global Clinical Operations
- Webinar: Navigating Early Phase CNS-Active Drug Development presented by Dr. Beatrice Setnik, Chief Scientific Officer
- Webinar: Comparing CTA Submission (EMA/Health Canada) to IND Applications (FDA) for Phase I Trials presented by Dr. Beatrice Setnik, Chief Scientific Officer and Paul Sidney, Senior Director, Compliance and Regulatory Affairs.
- Webinar: Navigating the abuse potential evaluation of CNS-active drugs for EU and US submissions presented by Dr. Beatrice Setnik, Chief Scientific Officer and Andy Mead, Head of Drug Abuse and Substance Use Disorders, Sygnature Discovery
- Webinar: The Brain on Drugs: The Strategic Use of Cognitive Measures and Biomarkers in Early-Phase CNS Drug Studies presented by Dr. Beatrice Setnik, Chief Scientific Officer and Dr. Denise Milovan, Clinical Neuropsychologist.
- Webinar: The Many Facets of Early Phase Evaluation of Psychedelics in Psychiatry presented by Dr. Beatrice Setnik, Chief Scientific Officer and Dr. Sharon Cheetham, Director and Assistant Professor at Sygnature Discovery
- Podcast: Choosing the Right CRO for your Clinical Trial Monitoring presented Ben Bjorge, Director Monitoring Services
For more information on our clinical, visit our website today.