Lambda Wins Award
 Read More


Learn more about our current studies.
Read more

Early Clinical


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

 

Services:


  • 134 beds including 12 Phase I beds with access to more than 640+ beds globally that can accommodate large panels, long institutionalization and mix population studies
  • 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
  • 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
  • A vigorous QC process to ensure data integrity
  • 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
  • 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 ECG’s & EEG’s, Pulmonary Function Testing (PFT), Cognitive Drug Testing (CDR), Gastroesophageal monitoring, cardiac monitoring, Radiology (X-rays, MRIs)
  • Clinical team comprised of medical doctors, registered nurses, technicians, and medical assistants

 

Subject Recruitment & Screening

 

Recruitment:


  • We recruit from a pool of >6+million residents in the Greater Toronto Area and surroundings
  • An active subset of 15,000+ subjects from a total database of 90,000+
  • Clients can have access to a large and ethnically diverse subject pool.  This allows LTR to recruit subjects rapidly and on-time
  • Prospective subjects are reached through a variety of media sources including advertisements in radio, newspapers, television, as well as our website
  • We utilize the “Clinical Eligibility Subject Recruiting” (CESR), a comprehensive database to track recruitment, screening, participation status and histories, including demographic and medical information

 

Screening:


  • All subject-screening activities are efficiently conducted in our screening center
  • Prospective subjects undergo an informed consent process, during which they are informed of their rights and obligations, potential risks and a detailed review of study procedures
  • Prospective subjects are involved in a pre-study interview, complete medical history, physical examination, collection of study demographics, ECG and vital signs
  • Prospective subjects are also tested for pregnancy, drugs of abuse, nicotine and alcohol for assessment of study eligibility based on the protocol requirements
  • We are directly linked to Gamma-Dynacare who provides central laboratory services for all of our clinical trials. They develop and use sophisticated instrumentation and systems, collection protocols, transportation, testing and reporting of results − all tailored to the unique requirements of each project. Gamma-Dynacare provides a quick turnaround of test results for blood chemistry, hematology, urinalysis for medical screening or other study specific requirements

 

Special Populations:


  • Post/Pre-menopausal females
  • Surgically Sterile
  • Obese
  • Geriatrics
  • Fast/Slow Metabolizers
  • Hypertensive
  • Diabetics
  • Migraine patients


Website Designed by Clutch Marketing