Clinical Trials

We understand the complexities of today’s clinical trial environment!

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
  • Market Evaluation
  • Data Management
  • Medical Writing
  • Audit and Regulatory Advisory Services
  • Risk Management offered through Omnisure Risk Management Consulting

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
  • Crisis Response/ Regulatory Coverage Included
  • Worldwide Coverage Included
  • Hired & Non-Owned Auto Coverage Available
  • Sexual Abuse Liability Available

Eligible Risks Include:

  • Independent Research Sites (IRS’s)
  • Contract Research Organizations (CRO’s)
  • Site Management Organizations (SMO’s)
  • Institutional Review Boards (IRB’s)
  • Data Management Safety Boards (DSMB’s)
  • NFP Research Institutes
  • Trial Sponsors/ Biotech Firms
Program Brochure
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