Pressure test your study before you start.

Using real world data and advanced analytics, experts from IQVIA can proactively identify issues in your clinical trial design.
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IQVIA Outcomes

92% unclear synopses

Percent of protocol synopses evaluated that were found to be unclear or inconsistent
Internal analysis, IQVIA protocol assessment

Reduce the risk of amendments and delays

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 

  • Electronic medical records 
  • Clinical research data 
  • Public data sources 
  • Industry benchmarks

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. 

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.

Source:  Impact Report (2014) Tufts CSDD

Control costs and avoid potential roadblocks

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

  • Testing for patient and site burden to identify barriers to patient recruitment and retention
  • Identifying non-core procedures so you can remove them to reduce study costs and complexity
  • Understanding competitors to benchmark design and enrollment strategies and maximize study value
  • Improving eligibility criteria to help recruit eligible patients and predict screen failure

Case Study:

Revising a Global Phase II Study

Situation

A mid-size pharma company was finalizing a protocol for a Phase II study in non-small lung cancer.

IQVIA Action

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.

Customer Result

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.

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Phase I Trials

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.

Phase IIb/III Trials

Improve the performance of your clinical trials with the power of the IQVIA CORE.

Site Identification

Identify the best performing sites for your trial in less time with new machine learning and predictive modeling methods.

Global Laboratories

Access central labs around the globe through Q² Solutions, a joint venture between IQVIA and Quest Diagnostics.

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