Services We Provide

Our clients include Fortune 500 companies, clinical research facilities, and universities. Among the services that we provide to these institutions are:

Data analysis and programming support of FDA, EMEA, and other regulatory agency submissions, including materials for the preparation of NDAs, PMAs, and 510(k)s.

Support for the preparation of submissions for product acceptance by the American Dental Association or other regulatory agencies.

Preparation of documentation to support advertising or other product claims.

We work closely with our clients to evaluate the requirements of their studies, and to design an appropriate package of services to meet their needs. We offer a wide range of services, including the following:

Statistical Services

Study design
Sample size / power calculations
Randomization
Data analysis / interim safety analysis

SAS Programming

Data summary tables
Data listings
Graphs, charts and figures

Specialized Applications

WinNonlin processing of pharmacokinetic data
MedDRA processing of adverse event data
Processing of Digitrapper Data from GERD studies

Data Management

Clinical data management using Clintrial
CRF design and development
Data query management
MedDRA and WhoDrug Thesaurus coding
External data integration with validation
Quality and edit checks on client database

Study-Related Documentation

Statistical reports
Clinical Study Reports
Statistical Analysis Plans
Case Report Form Design
Manuscripts
Abstracts and presentations

We're Significantly Statistical^Ž

In the event of a catastrophic loss of our facilities, our disaster recovery plan is designed to ensure that the complete restoration of data and resumption of processing can take place within 48 hours.