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As Pharmaceutical Industry Increases Use of Investigator Initiated Trials (IIT), Companies are Struggling to Effectively Manage IIT Programs

CHAPEL HILL, N.C., Dec. 1, 2017 /PRNewswire/ -- Pharmaceutical companies are investing more resources in investigator initiated trials (IITs) as they strive to expand their commercial opportunities.

Yet as organizations strive to improve and expand their IIT programs, they are struggling to ensure IIT proposals align with corporate objectives and also demonstrate scientific merit. Likewise, a significant increase in the number of IIT submissions necessitates that organizations manage their IIT programs effectively to not let costs leapfrog results.

One of the keys to overcoming these internal challenges is the use of a separate, dedicated team to manage IITs, according to a new study from pharmaceutical research leader Best Practices, LLC. "We are going to allocate specific people dedicated solely to IITs as it will work better. This can ensure that the investigators keep up the deal at their end by working with them and making sure they stay on track to complete that timeline," said an executive director of IIT trial management who participated in the study.

The report that grew out of the research study, "
Investigator Initiated Trials Management," presents current industry metrics on key aspects of IIT program management, including IIT team structure, staffing, budget and performance metrics.

This 60-page report serves as a reference point for those who oversee or work in investigator initiated trials so that they can compare the critical aspects of their IIT program with industry peers.

Topics addressed in the study include:
  • IIT Submission Review and Systems
  • Functional Involvement
  • IIT Funding
  • IIT Audit
  • Future Improvements
  • Important Criteria for IIT Evaluation
  • Key Reasons for Rejecting IIT Proposals

Best Practices, LLC engaged 30 leaders from 23 bio-pharmaceutical and medical device companies through a benchmarking survey. In addition, four leaders in IIT management were interviewed to provide qualitative data.

To learn more about this report, download a complimentary report excerpt at

For related research, visit the Best Practices, LLC Web site at


Best Practices, LLC is a leading benchmarking, consulting and advisory services firm serving biopharmaceutical and medical device companies worldwide. Best Practices, LLC's clients include all the top 10 and 48 of the top 50 global healthcare companies. The firm conducts primary research and consulting using its comprehensive proprietary benchmarking tools and analysis.

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