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Best Practice Database
Clinical Operations » Outsourcing in Clinical Trial Management
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As the pressure mounts for pharmaceutical companies to efficiently and effectively conduct clinical trials, companies are relying more often on Contract Research Organizations (CROs). This 13-page document outlines the strategies and tactics for managing partnerships between pharmaceutical companies and CROs. Information in this document will help pharmaceutical executives better leverage external expertise and improve the clinical trial process at their organization.
Sample Best Practices
1.Consider investigator satisfaction with a CRO when deciding which organizations to hire to ensure productive collaboration.
- To understand and improve site satisfaction, one CRO has its Quality Assurance department poll and question each study’s site to give project and senior managers a report card on the CRO’s performance.
2.Maintain in-house project staff for studies run by CROs to ensure internal accountability for the success of the project.
- In a recent study, one company worked with a CRO but had one of its physicians serve as the study’s medical monitor in order to allow the company to maintain contact with the investigators as medical questions arose.
3. Back up the CRO staff to investigators to reinforce the unified team approach and prevent finger pointing between the CRO and sponsor.
-One benchmarked company’s staff backs up the CRO’s monitors with the investigators when necessary and reinforces teamwork at investigator meetings.
This research originated from a Best Practices, LLC consulting project. It was conducted for a pharmaceutical client and was based on interviews and surveys with pharmaceutical, CRO and investigative site benchmark partners.