PAREXEL Adds Clinical Optimization Program

PAREXEL has added to its clinical development services with a new process, Clinical Development Optimization that uses technology to help expedite drug development through design, start-up, trial execution, and submission.
 
The protocol design optimization uses simulations to help identify and quantify the impact of trade-off decisions on program performance, timelines and cost. Integrated applications, site start-up, Clinical Trial Management System (CTMS), and electronic Trial Master File (eTMF) provide distribution, collaborative compilation and e-signing of site-level regulatory documents and contracts, and Clinical Trial Supplies & Logistics handles supply chain issues and supply levels.
 
Also, the program uses PAREXEL Informatics technology to help predict and capture core operational and scientific data, and Submit Data aggregation is aligned with commercial strategy to help ensure the right technology and operational support for an initial regulatory application and product lifecycle management.
 
 “Challenges in clinical trials can translate into lost revenue and significant delays in getting new, cutting edge medicines to patients,” said Sy Pretorius, M.D., chief scientific officer, PAREXEL. “To help clients overcome these challenges, we applied our advanced technology services and systems to the clinical development process. The result is data we can leverage to improve protocol design, patient recruitment, site selection and feasibility, and analysis and reporting for our clients.”