Products & Services

Product

CT Sure is a specialist underwriter for clinical trials in the South African market and underwritten by Guardrisk which is part of Momentum Metropolitan Holdings Limited, a level 1 B-BBEE Insurer.

We understand the intricacies surrounding clinical trials and have expert underwriters in place who examine the risk focusing on the sponsors needs to provide bespoke clinical trial insurance cover to safeguard our client and their participants in the trial.

CT Sure provides adequate financial protection for participants in any medical or treatment costs, and to provide appropriate compensation in the event of death or injury arising from the trial activity, which in turn reduces the reputational and financial consequences for the trial owner.

CT Sure wants to provide an enhanced insurance and risk solution for our valued policyholders and furthermore we have the best-graded reinsurers secured through Lloyd’s of London.

Product Overview:

  • “No-Fault” Compensation for Clinical Trials
  • All participants in clinical trials are covered by comprehensive insurance for injury and damage
  • Cover is provided in line with the SAHPRA Guidelines for Clinical Trials
  • Excess Applicable R10,000 for each and every claim
  • Option to waive applicable excess at an additional premium
  • Cover up to 12 months and then reviewed annually
  • Extended reporting period up to 36 months available at an additional premium
  • The cover is provided based on the number of participants and the level of risk of the clinical trial
  • The inception of cover is the first date of clinical testing
  • Although no provision is made for cancellation, we are prepared to refund all or part of premium if the trial does
    not go ahead or the number of research participants reduces. This concession is subject to us being advised
    accordingly within 90 days of the date on which we are told to incept the policy. After this 90 day period no
    premium refund will be made.
  • Communication and Mitigating Reputational damage cost – R100,000-00
  • Loss of earnings in respect of all Research Subjects – R100,000-00
  • Maximum Limit of Indemnity: R10,000,000-00 million in the annual aggregate
  • Maximum Sub-limit per Research Subject: 10% of the limit of Indemnity

Services

Underwriting

All underwriting and rating will be done by the underwriting manager and will be subject to the following criteria. All quotes, within the approved Delegated Authority, agreed by the Insurer, will be completed by the Underwriting Manager at Head Office. The exceptional cases will be referred to the Insurer for approval.

All requests will be attended to as per the Service Level Agreement (SLA), details of the SLA to be agreed between the Insurer and CT Sure.

When a case is submitted for a quotation all required documentation must be included with the request before a quotation can be completed.

The documentation required:

  1. A completed proposal form
  2. Approval of the study by the MCC
  3. The Protocol
  4. Research Subjects information and consent forms
  5. The “hold harmless/indemnification agreement signed by all research subjects.

Rating will be based on the type of research, severity, the number of research subjects and period of cover.

Marketing

Marketing and follow-up services will be done by the marketers and offered exclusively to a selected panel of brokers in each region.

Claims

All claims will be referred to as the claims manager to establish the validity of such claims. If it is established that a claim is not valid we will advise the broker accordingly.

All valid claims will be advised to the Insurer. The frequency and method of notification to the Insurer must be agreed.

All valid claims to be settled as per the agreed SLA.