PharmaNet Development Group is launching two technology platforms, Initiator and PKS, aimed at providing significant improvements in clinical study timelines by accelerating data acquisition and the processing of final client reports in its Phase I clinics.
These two platforms are designed to provide rapid data handling and to help eliminate potential transcription errors as data is processed through different software tools. According to the company, the data can be verified on-line and real-time information about the clinical study can be obtained in validated systems that provide the necessary audit trail features and compliance with 21CFR Part 11 standards.
"The investments in Initiator and PKS will help us to accelerate the availability of data to our clients and will help to further improve data integrity," said Riaz Bandali, president, Early Stage Development. "The implementation of these systems demonstrates our strong commitment to client service, study participant safety and quality in everything we do."
The company also implemented Initiator, a software system specifically built for Phase I studies to enhance the processing and monitoring of study participants and study data. According to the company, this platform enables rapid study set-up, automated CRF generation and better study recruitment and communication tools for general and special populations. In addition, mobile workstations allow for rapid data entry and data is captured directly using bar codes and interfaces to medical equipment, such as blood pressure monitors. The Initiator platform also interfaces with the company's LIMS, as well as its diagnostic lab software and investigational drug management system.