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  • Current: COMPREHENSIVE CLINICAL TRIAL SERVICES

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.

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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:

  • Manufacturing and analytical services for small molecules
  • Scientific, regulatory, and strategic guidance
  • Protocol development
  • Project management
  • Bioanalysis (small and large molecules)
  • Data management
  • Medical Writing
  • Biostatistics
  • Reporting
  • CDISC
  • Archiving
  • Study monitoring

PARTICIPANT RELATIONSHIP MANAGEMENT

call agentWe 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

WEBINARS AND PODCASTS
Learn More
  • 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
CASE STUDY
Learn More
  • First-in-Human
  • Drug Drug Interactions (DDI) Cardiovascular Medication
  • Evaluting Abuse Potential (HAP) neuropathic pain medication
  • Study - 505(b)(2) Regulatory Approval, Multiple NDA-enabling Studies
RELATED FACT SHEETS
Learn More
  • Bioanalysis General Overview 
  • Bioanalytical Assay List
  • Pharmaceutical Manufacturing
  • Integrated Research Support Services
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