Novo Insurance - Professional Insurance Services

Clinical Trials Liability Insurance

Type: Corporate Insurance | Category: Liability Insurance

Policy Details

Learn more about the Clinical Trials Liability Insurance policy.

Clinical Trials Liability Insurance

Description

Clinical Trials Liability (CTL) Insurance protects the sponsor, investigator, and trial site from legal liability arising out of injuries or harm caused to participants during the conduct of clinical trials.

What is This Policy?

Clinical Trials Liability Insurance protects companies and investigators against claims from trial participants who suffer harm during research. It is mandatory for clinical trials in India.

What is Covered

The policy covers legal liability for injury, illness, or death of trial participants arising from the administration or testing of drugs, medical devices, or other interventions as part of the approved clinical trial. It includes compensation payable as per DCGI guidelines, legal costs incurred in defending claims, and related medical expenses. Coverage is typically defined per subject, per trial, and per occurrence. Extensions are available for multi-site or multi-country trials.

Who Should Buy

Pharmaceutical and biotechnology companies, Contract Research Organizations (CROs), Hospitals, academic research institutions conducting trials, Principal Investigators (if not covered by sponsor)

Key Features

  • Covers bodily injury, illness, or death of trial subjects
  • Includes compensation, medical expenses, and legal defence costs
  • Mandatory per DCGI (Drugs Controller General of India) for trials in India
  • Policy issued per trial protocol, site, and number of participants
  • Worldwide jurisdiction possible for multinational trials
  • Can be extended to cover ethics committee liability

Get in Touch

Request a free consultation for the Clinical Trials Liability Insurance policy.

Contact Information

123 Financial District, Hyderabad, Telangana 500032

+919100509675

info@novoinsure.com