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Scientific Affairs


Qualified, trained & experienced team of statisticians, SAS programmers, pharmacokineticists, and medical writers providing high quality data analysis & statistical report writing in accordance with regulatory standards


Pharmacokinetics & Biostatistics:


Pharmacokinetics:

 

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

 

Biostatistics:

 

  • Sample size and power calculations
  • Randomization schemes
  • Development of sophisticated statistical analysis plan (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

 

Medical Writing:

 

  • High quality data presentation & writing in accordance with global regulatory standards with sophisticated planning and execution
  • Experienced-based study protocol & ICF development
  • Integrated study report writing in eCTD format with hyperlinking & bookmarking
  • Preparation of FDA Summary Tables for ANDA Submissions
  • Custom format reports
  • CD-ROM copy and hard copy of reports and associated study data
  • CS-BE preparation for TPD submissions
  • Compilations of abstracts, manuscripts, publications & poster presentations


The integrated study report is the final deliverable that LTRI provides its clients, so that our goal is to issue this report in the shortest time possible.


Our standard reports are prepared to conform to the requirements of the ICH E3 “Structure and Content of Clinical Study Reports”. Past experience and regulatory expertise ensures that reports are written to minimize any possible delay in regulatory approvals.

 

Regulatory Affairs:

 

  • IRB Submissions
  • CTA preparation & filing
  • Liaise with the IRB
  • Import & Export and investigator use permits preparation for controlled substances and Class A precursors
  • Consultation with regulatory agencies (FDA, TPD, EMA)

 

CTA

 

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 IV 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, CTA is filed with Health Canada 2-3 weeks before dosing.  Health Canada has aggressively maintained the 7-day administrative review target
  • For Phase I-III studies, a CTA is filed with Health Canada 4-6 weeks before dosing.  The review typically takes 10-15 calendar days although the default review period is 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 IRB submissions

 

Institutional Review Board (IRB)

  • http://www.irbservices.com
    • Central independent ethics committee
    • Weekly meetings
    • Rapid turnaround time for receipt of review letters and study approvals
    • Complies with DIV 5 21 CFR Part 56 + 312.3 +454CFR46 regulations

 



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