Primary Casualty

Clinical Trials

General Star provides coverage for sponsors of clinical trials for pharmaceuticals or medical devices.

Coverage Offered

  • Excess Commercial General Liability, Products/Completed Operations Liability and Professional Liability on a claims-made basis
  • Excess Automobile Liability and Employer’s Liability if needed
  • Worldwide coverage territory
  • Non Admitted in all 50 States
  • Defense inside or outside the limits of insurance
  • Retroactive date at inception of the clinical trial
  • Minimum $5,000 deductible (higher depending upon the trial)

Risk Appetite

  • Sponsors and sponsor/investigators of clinical trials for pharmaceuticals and medical devices

Limits Available

  • $4,000,000 excess of $1,000,000 Primary
  • $5,000,000 excess of $5,000,000 Primary
  • $10,000,000 Limit and/or a higher attachment considered on a risk by risk basis

Ineligible Exposures

Trials involving

  • Implantable medical devices
  • Obesity/weight loss drugs or treatments
  • Gene therapy administered to healthy patients
  • Minors as subjects for psychopharmacologic or psychotropic drugs

Underlying Requirements

  • General Liability & Products/Completed Operations
    • $1,000,000 Each Occurrence/$1,000,000 Aggregate
  • Automobile Liability
    • $1,000,000 CSL
  • Employer's Liability
    • Varies by State
  • Underlying Carriers with a Best Rate of A- V or better are acceptable

Special Submission Requirements

  • Cover letter including a description of the trial, name of the trial, site of trial, number of subjects, trial duration, age of subjects and possible side effects to subjects
  • Signed Life Science/Biotech/Clinical Trials Application
  • Patient/Subject Informed Consent
  • FDA approved Protocol
  • ACORD applications and loss information