REQUEST for PARTICIPATION in the MVA CLINICAL TRIALS INSURANCE SCHEME

Medicon Valley Alliance offers participation in a Human Clinical Trials Insurance Scheme (MVA-HCTI).

The insurance scheme provides coverage for single-center and multi-center trials worldwide, sponsored by Medicon Valley-members.

Certain Sponsors and trials, considered high risk, will not be found eligible for the program e.g. due to type of product, compound or device.

The insurance scheme is placed with QBE Insurance (Europe) Limited and consists of a Master policy with the following shared limits:

  1. EUR 10.000.000 per claim and EUR 20.000.000 in the annual aggregate,
  2. EUR 20.000.000 per claim and EUR 40.000.000 in the annual aggregate,
  3. EUR 30.000.000 per claim and EUR 60.000.000 in the annual aggregate.

Sponsors may elect to participate in shared limits of EUR 10 mill, EUR 20 mill or EUR 30 mill.

In addition, QBE and its cooperation partners will issue the necessary certificates and policies in accordance with statutory requirements and with statutory limits in all countries, where the trial is performed. Any locally issued policies and their limits will apply to the specific trial and Sponsor only, and will not be shared with other participants. The Master policy will cover over and above locally issued paper.

Premiums are quoted per trial subject and dependent on the study’s specific risk profile, in which territories the trial will take place and the elected limit. Premiums are offered at a 40% discount compared to standard underwriting premiums. For locally issued policies a minimum premium will apply. Adjustment of premium based on actual no. of trial subjects will take place under locally admitted policies, not under the Master policy.

Please refer to the more detailed program description in the PROGRAM DESCRIPTION made available once participation has been approved.

Confidentiality: All recipients of information are bound by law to keep all information regarding the trial strictly confidential.

Application procedure:

Step 1: In order to save time, we will make an initial evaluation of Sponsor and trial eligibility for the insurance scheme. For that we need some basic information about you and the specific trial, for which insurance is requested. Please see below.

Step 2: Once the Sponsor and trial has been found eligible, you will receive a logon to the MVA intranet, where you will gain access to the MVA Risk Information Questionnaire.

Step 3: Based on the risk information, the Insurers will provide a quotation of the premium for your participation in the program.

Step 4: If you elect to participate and accept the quotation, the Insurers will issue Certificate(s) of Insurance in accordance with the elected limit. In addition, they will provide you with any other policy documentation in accordance with regulatory requirements in each country.

Please fill in:

Company name: / Click here to enter text.
Company address: / Click here to enter text.
Contact person: / Click here to enter text.
Telephone & E-mail: / Click here to enter text.
Medicon Valley Member: / Please tick: yes no

Please provide the following basic information about the trial for which insurance coverage is needed:

Trial ID & Phase: / Click here to enter text.
Short description of trial and indication: / Click here to enter text.
Country or countries in which the trial will take place: / Please list:Click here to enter text.
Expected no. of trial subjects: / Click here to enter text.
Trial subject profile (age, gender etc.): / Click here to enter text.
Expected first submission date: / Click here to enter text.

Does the trial implicate one of the following types of product or compound:

Type of Product/Compound: / If yes, please tick:
Antipsychotics
Contraceptives
Cox-2 inhibitors
Dioxins
Flenfluramine
Germanium
Hormone Replacement Therapy
Leflunomide
Methylphenidate
Monoclonal Antibodies
Nefazodone
Phenylpropanolamine (PPA)
Selective Serotonin Reuptake Inhibitors
Skin Whitening or Lightening Agents
Thalidomide
Thimerosal (Thiomersal)
Thiazolidinediones
Vigabatrin

If the trial includes one of the above products or compounds, it may not be insurable under the program. In all cases further information and evaluation will be required.

Please let us know whom you prefer us to communicate with regarding insurance questions, queries and quotations:

Company:
Trial manager
CRA
Clinical Coordinator
Risk Manager
External:
CRO
Insurance Broker
Law Firm / Please provide contact details:Click here to enter text.

Date & Signature:

Please send as pdf per e-mail to:

MVA, Claus Højlund ()