Lambda Canada | Scientific Affairs
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Scientific Affairs


  • Pharmacokinetics (PK) and Pharmacodynamic (PD) study designs
  • PK/PD modeling
  • Non-compartmental and compartmental, PK/PD, and population PK analyses


  • Sample size and power calculations
  • Randomization schemes
  • Development of sophisticated statistical analysis plans (SAP) including Mock Tables, Listings and Figures (TLF’s)
  • Statistical programming and data analysis for PK, PK/PD, efficacy, and safety endpoints
  • CDISC compliant SAS Export Package
  • Statistical consultation and education
  • Ad hoc and retrospective analyses

Data Management

  • Electronic case report form (CRF) design and development
  • Database design & validation
  • Data management & validation plan preparation
  • Coding of AEs & concomitant treatments
  • Data entry validation, tabulation, control & clarification
  • Database lock
  • Data Clarification Form (DCF) Management

Scientific and Regulatory Affairs

  • Experienced-based study protocol & ICF development
  • Review and update Standard Operating Procedures (SOPs) according to changes in industry or regulatory standards
  • Clinical Trial Application (CTA) and Ethics Submission of all Study related documents
  • Consultation with regulatory agencies (FDA, TPD, EMA etc.)
  • Import & Export and investigator use permits preparation for controlled substances and Class A precursors
  • The integrated study report is the final deliverable that LTRI provides its clients. Following up to date regulatory requirements, our goal is met and exceeds sponsors expectations with the shortest timelines without compromising our quality


Health Canada’s Therapeutic Products Directive (TPD) is the federal authority that regulates pharmaceutical drugs and medical devices for human use.  A Clinical Trial Application (CTA) must be filed before the initiation of a clinical trial in Canada.  Sponsors must file applications to conduct clinical trial in Phases I through III of drug development and comparative BA/BE trials. This includes applications to conduct clinical trials involving marketed products where the proposed use of the product is outside the parameters of the approved Notice of Compliance (NOC) of Drug Identification Number (DIN) application:


  • For BA or BE studies,  Health Canada targets 7-day administrative review process
  • For Phase I studies in healthy humans Health Canada has default review period of 30 days.
  • More than 95% of our clients worldwide take advantage of our in-house regulatory service, which ensures seamless submissions of CTAs relative to Ethics submissions

Institutional Review Board (IRB)

  • Lambda Canada’s local IRB is Optimun
  • We are able to work with any central or local IRB’s suggested by the sponsor
  • Central independent ethics committee
  • Weekly meetings/ Flexible Scheduling
  • Experienced members and staff
  • Prompt responses/ Turnaround time for receipt of review letters and study approvals
  • Proper Documentation
  • Single-center or Multi-center review
  • Customized Documentation Forwarding
  • Continuing Review
  • Complies with ICH-GCP