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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, biostatistics impacts a clinical study at all stages Biostatistics is one of the most crucial elements for any successful clinical trial because it produces tested, science-based answers. With the data produced by biostatistics, facts and justifiable methods are easier to come by.
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
Bioequivalence & Bioavailability
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
Project Management
High quality project management is the key to the success of a clinical trial.
Our experienced project management team has extensive expertise in managing clinical trials across a wide range of therapeutic areas and utilising numerous different study designs.
Our project managers are responsive and will provide you with all the immediate and longer term support that you need. A dedicated manager will be assigned at the outset of your project and will remain your primary point of contact throughout the project lifetime.
We also recognise the importance of excellent communication. To this end, the project manager leads the clinical trial team and works closely with key departments, external contractors and the sponsor to ensure seamless and timely communication and successful completion of the project.
Our project managers are highly skilled at identifying and prioritising risks and we have established processes in place.