About our list of Services

Use the column to the left to read important details and topics regarding each service in particular

We ecourage you to contact Ocean Blue Medical Research Center for more questions and/or information about our services.

Pharmacokinetics/Pharmacodynamics

Statistical Data Analysis

Ocean Blue Medical Research Center lab services performs pharmacokinetic and statistical analyses using SAS® and WinNonlin software. Concentration-time data acquired in our facility (Part 11 compliant) is transferred directly from Watson LIMS System to WinNonlin for its analysis.

Pharmacokinetic studies and statistical services and solutions offered by Ocean Blue Medical Research Center include:

  • Pharmacokinetic and pharmacokinetic/pharmacodynamic modeling
  • Noncompartmental analysis
  • Bioequivalence and bioavailability testing
  • Clinical pharmacokinetics
  • Preclinical pharmacokinetics/toxicokinetics
  • Determination of effects on dosing regimen and patient demographics on pharmacokinetics

Pharmacokinetic and PK / PD Reports

Ocean Blue Medical Research Center, as provider in drug development solutions, counts with an experienced team in developing formal Data Analysis Plans (DAP) or Statistical Analysis Plans (SAP) detailing study objectives, methods and organization and representation of pharmacokinetics results. An analysis plan ensures that final reports address study protocol requisites and meet sponsor needs.

Biostatistical Services

  • Design and implementation of randomization scheme
  • Development of Statistical Analysis Plan (SAP)
  • Sample size rationale and statistical power
  • Methodology for summary and analysis of demographic, baseline, efficacy and safety data
  • Description of statistical methodology
  • SAS programming for tables, listings and figures
  • Production of tables, listings and graphs in compliance with ICH guidelines
  • Performance and validation of statistical analyses
  • Interim analysis
  • Bioequivalence
  • Linear and non-linear modeling
  • Parametric and non-parametric analysis of clinical and PK endpoints
  • Production of statistical report/assistance with clinical report
  • Statistical management throughout the project
Last update: 07/7/2015 11:24
Content updated on Monday, 10-2-2017 04:35:40 am