General Star provides Excess Liability 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

Target Risks

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

Limits

• $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