Physiologically based pharmacokinetic (PBPK) modeling to support the design of clinical drug-drug interaction (DDI) studies has continued to increase in NDA submissions for the last ten years.
As regulatory guidance and data collection in clinical trials has evolved, sponsors face pressure to balance quality, productivity and cost for risk management and monitoring. The industry has adopted risk-based quality management (RBQM), yet the methodology is inconsistent.
The Xcellerate Protocol Design Tool accurately assesses the number of people that meet the study criteria, models the data to maximize the available patient pool and pinpoints geographic clusters of people who fit the defined eligibility criteria to more efficiently recruit and fill your trials.
Xcellerate Patient Intelligence provides actual patient feedback from over 30 countries across 50 indications that can be used to help design protocols that reduce the burden on patients and caregivers.
Cost is a major factor in executing a clinical trial. Sponsors are continually seeking ways to reduce their financial risk in early Phase I and human absorption, metabolism and excretion (hAME) studies. Beginning a full CMC campaign only to have to cancel it or change formulation based on late toxicology results or safety data can add expensive delays.
Learn from three thought leaders in the field of immunotherapy as they share their knowledge on trends and advances across the entire spectrum of development.
