When you are investing millions in developing a new drug, finding hidden costs before they become real problems is mission-critical.
IQVIA offers a systematic approach integrating advanced analytics, therapeutic expertise and real world data that can substantially improve planning, feasibility and enrollment targets. Sources include
This approach allows you to develop or optimize a protocol design to deliver the right data from the start, without unexpected issues or unnecessary costs.
Source: Impact Report (2014) Tufts CSDD
1/5 of Phase II protocols and 1/3 of Phase III protocols collect non-core data that’s irrelevant to the study’s goals and requirements.
Whether you’re in the process or have already developed your study protocol, IQVIA can ‘pressure-test’ it using real world data to check for precision, clarity and consistency, including
A mid-size pharma company was finalizing a protocol for a Phase II study in non-small lung cancer.
We performed an analytics-based review of the protocol, identifying two design decisions that increased study risk: 1) neither of the co-primary endpoints were similar to comparable trials for this indication, and 2) this protocol included more and different QoL/PRO measurements.
In addition, we identified a design inconsistency: a missing PK/Antidrug antibody schedule for the comparative arm.
By revising the protocol to include the missing schedule, the customer avoided risk of protocol deviations, missing data and budget overruns. Also, the primary endpoint was changed to better align with comparable NSCLC trials, potentially mitigating regulatory risks.
Apply real world data to your trial with nonidentified data from more than 500 million patients across eight countries using pre-built analytics.
Leverage a global network of Phase I clinical pharmacology units to build diversity in patient populations and access a range of geographic regions for early clinical development (ECD) programs.
Improve the performance of your clinical trials with the power of the IQVIA CORE.
Identify the best performing sites for your trial in less time with new machine learning and predictive modeling methods.