PAREXEL International Corporation has announced the enhancement of its end-to-end clinical development services through its new process, called Clinical Development Optimization. The PAREXEL® Clinical Development Optimization process uses advanced technology to help expedite drug development through all four critical stages of clinical development – design, start-up, trial execution, and submission.
Two significant challenges in clinical trials today are patient recruitment and protocol-related delays. Forty-eight percent of sites miss enrolment targets, and study timelines are often extended to almost double their original length to meet enrolment levels. Additionally, on average, two to three protocol amendments can delay a trial by two months, with each amendment adding $500,000 in additional costs.
“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.”
PAREXEL Clinical Development Optimization increases the efficiency of all stages of clinical development:
• Design: Protocol design optimization using simulations enables sponsors to identify and quantify the impact of trade-off decisions on program performance, timelines and cost.
• Start-up: Site start-up, Clinical Trial Management System (CTMS), and electronic Trial Master File (eTMF) integrated applications provide efficient distribution, collaborative compilation and e-signing of site-level regulatory documents and contracts. Clinical Trial Supplies & Logistics handles supply chain challenges and optimizes supply levels.
• Execute: Intelligent technology from the PAREXEL Informatics product line helps predict and capture core operational and scientific data.
• Submit: Data aggregation aligned with commercial decision-making strategy can help ensure the right technology and operational support for an initial regulatory application, identification of future opportunities, and product lifecycle management.
“The role of information technology in clinical development continues to grow. Clients now expect faster study start-up, advanced site feasibility, accelerated patient enrolment, real-time surveillance, risk-based monitoring, and better data standardization,” said Xavier Flinois, President, PAREXEL Informatics. “Ultimately, PAREXEL Clinical Development Optimization gives our clients the tools to make technology-enabled and data-driven business decisions, helping to reduce risk, increase clinical trial efficiency, and speed time to market for our clients and for patients.”