PharmaNet launches Initiator and PKS technology platforms to improve clinical study timelines

Dec 15 2010

PharmaNet Development Group, Inc., a leading provider of clinical development services to pharmaceutical, biotechnology, generic drug and medical device companies, is pleased to announce that it is launching two technology platforms – Initiator™ and PKS™ - that will provide dramatic improvements in clinical study timelines by accelerating data acquisition and the processing of final client reports in its Phase I clinics. By providing clients with real time data faster, sponsors can make informed decisions about their products earlier in the process.

Clinical studies require the handling and management of massive amounts of data. Many aspects of these processes still remain largely manual. With the launch of these two new technology platforms, PharmaNet will accelerate these processes, provide rapid data handling and eliminate potential transcription errors, as data is processed through different software tools. 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."

During 2010, the Company made significant investments in the implementation of PKS™, WinNonlin® and WinNonlin® Autopilot™, a complete PK/PD data management and reporting solution. This suite of products, provided by Pharsight, is used by several major pharmaceutical companies. PharmaNet is the first full-service CRO to implement PKS as part of its clinical pharmacology service offerings. This centralized data repository houses all PK/PD data, analysis and objects related to a study and seamlessly interfaces with the Company's laboratory information system and other CDISC formatted data sources.  Final PK/PD data and analysis are flexibly produced in standard or customized reports.

To enhance the processing and monitoring of study participants and study data in its Phase I clinical operations, PharmaNet has also implemented Initiator™, a software system specifically built for the efficient conduct of Phase I studies. The implementation of this platform enables rapid study set-up, automated CRF generation and better study recruitment and communication tools for general and special populations. 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 laboratory software and investigational drug management system.

"The combination of diversified experience, access to special populations and efficient, quality driven business, clinical and reporting systems places PharmaNet at the forefront of Phase I clinical development," added Mr. Bandali.