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Pharmacokinetics

 

Notrox provides GLP-compliant services from discovery through development in our state-of-the-art facility

 

Our team has extensive experience in providing a wide range of statistical services.

 

These statistical services include the key processes outlined below.

 

STUDY DESIGN

The study design process covers elements such as sample size calculation, endpoint definitions and statistical methodology. Discussion of these elements occurs within the clinical project team at the earliest possible stage of protocol development.

 

STATISTICAL ANALYSIS PLANS

Statistical analysis plans are produced during the clinical phase and include populations, parameters for analysis and primary and secondary endpoints. In addition all statistical methodology is incorporated into the statistical analysis plan from the protocol.

 

CLINICAL DATA REVIEW

A full data review is carried out by our clinical team of physicians, statisticians and project managers. Primary efficacy parameters and standard safety data are reviewed during this process. Subject populations are also drawn up, along with listings of protocol violators.

 

PROJECT PROGRAMMING AND DATA TABULATIONS

Standard and study specific safety and efficacy tabulations are designed and programmed well in advance of database lock. This ensures preliminary results are reported to the client within days of randomization code release. Data summaries are in-line with ICH requirements outlined in E3, structure and content of clinical study reports.

 

STATISTICAL ANALYSES AND REPORTING

The quality controlled statistical analyses are prepared by our statisticians. The collation of the protocol, statistical analysis, data listings and summary tables are prepared by our report writers with advice from our statisticians and physicians. Finally, our internal independent reviewers ensure the draft and final reports are produced to the highest possible standards.

 

Revisit your Project from the Perspective of Statistical Analysis from conceptualization to the final analysis and interpretation of results, bio statistics impacts a clinical study at all stages Bio statistics is one of the most crucial elements for any successful clinical trial because it produces tested, science-based answers. With the data produced by bio-statistics , facts and justifiable methods

 

Whether your project requires appropriate study design, selection of endpoints, correct analysis methods, sample size estimation, statistical programming, and the ability to make sound decisions is vital to your success. Quite simply, math and science-based statistical analysis awakens that success.

 

The key to making the right decisions
As an international full service CRO, Notrox helps you to make befitting decisions regarding these crucial aspects by providing the full scope of statistical and programming services. Some of these services include:

  • Protocol
  • Sample size estimation
  • Data derivation and mapping to CDISC standards
  • Output generation and analysis
  • Full DMC support, including preparation of the DMC charter
  • Interpretation of results and input to Clinical Study Reports

 

 

Our Experience

Our global department of experienced medical statisticians and statistical programmers have considerable ongoing experience in all aspects of statistical services including:

  • Phase I to IV trials, including analysis of PK and PD parameters and quality of life data
  • Non-interventional studies
  • Integrated safety and efficacy summaries for submission

 

Notrox statistical expertise thoroughly covers all major therapeutic areas. Furthermore, our experts have a profound understanding of even the most complicated statistical methodologies and trial designs, including adaptive designs.

 
Providing Solutions for your Study

Our philosophy is to design customized solutions through flexible service models with rigorous quality control processes. We aim to exceed the expectations of our diversified client base. Our innovative methods of designing customized solutions is one of the key reasons clients trust our company to provide the medical services they need.

  • Pharmacokinetics/Toxicokinetics
  • Bio equivalence & Bio availability
  • Single or Multiple Dosing (In-life)
  • PK/TK Analysis
  • IVGTT, OGTT, & Glucose Clamps
  • Meal Interference/Glycemic Challenge
  • Routes of Dose Administration
  • Parenteral (IV/SC/IM/IP)
  • Ocular
  • IV Infusion
  • Auricular
  • Intranasal
  • Rectal/Intravaginal
  • Dermal/Intradermal/Transdermal patch
  • Oral (gavage/liquid/ tablet/capsule)
  • Vascular Access Ports (VAP)
  • Intracoronary/Intraventricular (percutaneous access)
  • Rodent Vascular and Non-Vascular Cannulas