Press Room

November 8, 2009

The US Food and Drug Administration has awarded FEFA the contract to provide the development of a web-based, metadata driven software tool for clinical protocol review.

 

August 1, 2009

FEFA has been awarded a contract to provide 508 compliance services to the US Food and Drug Administration.

 


Data Management

Data Management FEFA’s data management and analysis services prides itself on assuring the integrity of the data generated and its meaningful interpretation. Our qualified staff conducts, or assists in the collection of data, and provides data management in a scientific, timely and reliable manner. Our experts have strong expertise in a broad range of therapeutic areas and data management technologies. Data management services are provided for Phases I to IV clinical studies, Bioequivalence studies, Post-Market Clinical trials and Post-Market Surveillance (Use-result surveillance, Special surveillance).

Such services include:

· Data Capture Mechanisms Design and Implementation

· CRF (Paper and Electronic)

· Entry Screen Development, Validation

· Data Input, Data Flow Management

· Logic Checks, Double Data Entry

· Query Generation and Resolution

· Audit trail and Overall Data Flow Control

· Quality check, Database Locking

· Data Export and Analysis

· Data exports to SAS®, Excel, etc

· Statistical Analysis in SAS®, WinNonLin, etc

· Data Interpretation and Report Writing

· Expert Medical Writing

· Expert Group Sessions Management