Lambda Canada | Early Clinical
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Early Clinical

Phase I, Bioavailability (BA)/Bioequivalence (BE)

Lambda Canada offers a wide spectrum of Early Clinical services including Phase I (First-in-Human) with extensive monitoring and Bioavailability (BA), Bioequivalence (BE), Pharmacokinetics (PK), Pharmacodynamic (PD), Interaction studies (drug/drug, drug/alcohol),  Dose Escalation (SAD/MAD), Safety & Tolerability, Dose Ranging and Vaccine studies. The services are supported by a clinical team comprised of medical doctors, registered nurses, technicians, and medical assistants as well as 142 beds including 12 Phase I beds with access to more than 700 beds globally that can accommodate large panels, long institutionalization and mixed population studies.

 

  • A vigorous QC process to ensure data integrity
  • Proximity to emergency facilities
  • State-of-the-art emergency and resuscitation equipment
  • Dedicated controlled access pharmacy with continuous temperature & humidity monitoring
  • License to import and secure storage of narcotics & controlled drug substances
  • Provide ECGs , Pulmonary Function Testing (PFT)
  • Skin Blanching Studies using chromameter

Experience:

  • Experience in working with a broad variety of therapeutic areas including cardiovascular, infectious diseases, psychiatric, gynecological, endocrine, neurological, anti-inflammatory, anti-infective, analgesic, gastrointestinal, respiratory, urological, dermatological
  • Extensive experience with a variety of dosage forms including immediate release (IR), controlled release (CR) modified release (MR), extended release (ER),  solid oral, oral thin films (OTF), oral dispersible tablets (ODT), sublingual, suppositories, inhalers, injections, patches, suspensions and nasal spray

Subject Recruitment & Screening

Recruitment:

  • We recruit from a pool of 6+ million residents in the Greater Toronto Area and surroundings
  • An active subset of 35,000+ subjects from a total database of 50,000+ volunteers
  • Access to a large and ethnically diverse volunteer population
  • Volunteers are reached through a variety of media sources including advertisements in radio, newspapers, television as well as our website
  • We utilize our proprietary software (BizNET) – a clinical trial management system, which facilitates volunteer recruitment and tracking volunteer enrolment from booking for screening until the completion of the study
  • Recruitment of volunteers includes a telephonic screening process to determine their eligibility for participation in a study

Screening:

  • All subject-screening activities are efficiently conducted in our clinical facility
  • Interested volunteers undergo an informed consent process, during which they are informed of their rights and obligations, potential risks and a detailed review of study procedures
  • A pre-study interview is conducted and complete medical history, physical examination, collection of study demographics, ECG and vital signs are documented
  • All volunteers undergo tests for drugs of abuse, nicotine and alcohol for assessment of study eligibility based on the protocol requirements, including a pregnancy test for all females
  • We are directly linked to Dynacare who provides central laboratory services for all of our clinical trials. Dynacare provides a quick turnaround of test results for blood chemistry, hematology, urinalysis for medical screening or other study specific requirements

Special Populations

  • Postmenopausal females – Natural and Surgically Induced
  • Surgically Sterile females
  • Hypertensive
  • Diabetics
  • Obese
  • Smokers