- Commercial General Liability, including Products and Completed Operations plus limited Professional
- Written on Claims-Made coverage form
- Defense inside or outside the limits of insurance
- Retroactive date at inception of the clinical trial
- Rating is based on the number of subjects
- Sponsors and sponsor/investigators of clinical trials for pharmaceuticals and medical devices.
Eligible Exposures
- The sponsor of clinical trials for either a new pharmaceutical or medical device
Ineligible Exposures
- Trials involving:
- Implantable medical devices
- Obesity / Weight Loss
- Gene therapy administered to healthy patients
- Minors as subjects for psychopharmacologic and psychotropic drug trials
- Minimum $5,000 deductible (higher depending upon the trial)
- Cover letter including a description of the trial, name of the trial, site of trial, number of subjects, trial duration, age of subjects and potential side effects
- Signed General Star “Biotech & Clinical Trials Application” or equivalent clinical trial application
- Patient/Subject Informed Consent
- FDA approved Protocol
- ACORD applications and loss information
