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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