In an increasingly complex regulatory environment, CRO staff, investigators, and clinical trial teams need to be well-informed, while continuously engaging with sponsors to manage the trial process. Pro-Praxis understands the need for customized solutions to address the specific needs of the various stakeholders.
The business written through the Pro-Praxis Program is intended to ensure, on a surplus lines basis, eligible risks that support, oversee, or sponsor clinical trials activity. By responding to the medical and administrative professional exposures arising from a clinical trial, our product sets the standard for addressing the comprehensive needs of this niche marketplace.
“Clinical Research Professional Services” includes:
- Medical Professional Services
- Manufacturing, Designing, Handling or Distribution of a Drug or Device in a Clinical Trial
- Pre-Clinical Services
- Quality Assurance
- Protocol Design
- Participant Recruiting
- Consulting
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- Market Evaluation
- Data Management
- Medical Writing
- Audit and Regulatory Advisory Services
- Risk Management offered through Omnisure Risk Management Consulting
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Overview:
- Up to $20M Total Capacity
- Primary & Excess Placements
- Follow Form Available (above select lead markets)
- Defense Outside the Limit
- Individuals Named on FDA 1572 Form Covered
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- Crisis Response/ Regulatory Coverage Included
- Worldwide Coverage Included
- Hired & Non-Owned Auto Coverage Available
- Sexual Abuse Liability Available
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Eligible Risks Include:
- Independent Research Sites (IRS’s)
- Contract Research Organizations (CRO’s)
- Site Management Organizations (SMO’s)
- Institutional Review Boards (IRB’s)
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- Data Management Safety Boards (DSMB’s)
- NFP Research Institutes
- Trial Sponsors/ Biotech Firms
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