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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©2024 Pro-Praxis is a division of and operates under the license of CRC Insurance Services, LLC, CRC of California Insurance Services, CA Lic No 0778135. No claim to any government works or material copyrighted by third parties. Nothing on this website constitutes an offer, inducement, or contract of insurance. Financial strength and size ratings can change and should be reevaluated before coverage is bound. This material is intended for licensed insurance agency use only. This is not intended for business owner or insured use. If you are not a licensed agent please disregard this communication.