Nth Latest

What We Do

Biostatistics

Our Masters and Ph.D. statisticians have substantial pharmaceutical experience in many clinical areas including vaccines, oncology,  endocrinology and CNS.

In the pharmaceutical industry, statistical analysis requires extreme attention to detail.  We can work with your most-demanding in-house statisticians to provide the accurate results you expect using standard processes employed within the pharmaceutical industry.

We provide the following services: Randomization, Data Safety Monitoring Board (DSMB) analyses, analysis plans, statistical programming specifications (e.g., table mockups), analysis datasets (ADaM), validation, statistical reports, and publication support.

SDTM Conversions

Get the details right!

Nth Analytics was among the first companies to qualify as a CDISC Registered Solutions Provider. One of only 21 such companies in the world, Nth Analytics was certified by the CDISC Technical Coordinating Committee to have, among other specialized criteria, an expertise in CDISC models. Approved CDISC Solutions Providers are qualified consultants, system integrators, and subject matter experts believed by CDISC to have sufficient knowledge and experience implementing the various CDISC standards.

We have done many SDTM conversions, from both current and legacy data, in vaccines, oncology, CNS, and other therapeutic areas. With over 40 years combined experience in data management, statistics, and programming, we identify cost-saving commonalities among your studies while still addressing all the nuances of each individual study.

Validation

We offer validation services in several areas. We are extremely detail-oriented and do a thorough job every time.

Tables, Listings, and Figures

Quality control (QC) review of the tables, listings and figures (TLFs) from the study data will help insure the accuracy and integrity of the data used in reporting the results of the study. A complete, extensive review takes place on the draft output, prior to sending the output to the client. Subsequent rounds of QC on final output may be less extensive, but must still be adequate to determine that the output is accurate.

SDTM

Our validation goes beyond what simple double programming can do. It includes review of the annotated CRF and mapping specifications for accuracy, full documentation of source data intentionally not mapped to SDTM, and detailed review of each SDTM file on the subject level.

We have developed a series of checks that validate compliance to SDTM standards. These are based on the 105 published checks used by the Lincoln Technology WebSDM product. These are the same checks used by the FDA upon receipt of your SDTM files. Passing these checks no ensures that you will have one less problem during your submission process.  

SDLC

We are very familiar with pharmaceutical SDLC methodology for system design and validation. We have done extensive SDLC projects for two large pharmaceutical companies under their stringent SOPs: our work passed their strict internal audits! Deliverables included:

Functional requirements specification (FRS)

System design

Entity-module matrix

Unit, integration, and system test plans and specifications

UAT plan and evaluation of UAT results

User manuals.

Pharmacokinetic (PK) and pharmacodynamic (PD) analyses in clinical drug development are critical steps in the drug approval process. We can provide these services through our partner Pharmax Research in Somerset, NJ. Pharmax's mission is to provide clinical research and development solution for pharmaceutical and biotechnology companies.

Pharmax's scientists have specific expertise in the application of PK and PD principles to clinical drug development, including population PK/PD modeling.

Sam Liao Ph.D. is the principal PK scientist for Pharmax Research. Sam's extensive experience in pharmaceutical R&D includes over 20 years in Clinical Pharmacokinetics and over 10 years experience in NONMEM population PK/PD modeling, as well as five years experience in Pharsight Trial Simulator™ for clinical trial simulation. Read more about Pharmax Research.

Contractors

We provide experienced SAS programmers and statisticians on short notice at very competitive rates. All of them are fully screened, including reference checks.  We interview each candidate to determine not just their technical skills, but how they will do in your particular situation. With our long pharmaceutical experience, we can screen the candidates very effectively. The key criteria we look for are:

Technical ability

Professionalism

Ability to handle pressure and meet deadlines

Validation/accuracy

Contractors: looking for opportunities? click here

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