Norway

Norway

Norway

Norway

Clinical Trial Application

n/a

Mandated Coverage

Yes and No. Insurance is mandatory for drug testing via "Liability for Drugs Association" in Norway

Drug Sponsor must apply for insurance direct at the following site:
https://laf.no/

Device trials can be covered by the US Master Policy

Standard Limits

n/a

Tail Coverage

n/a

Data Required to Quote

If the trial is Device-related as mentioned above, please submit an email request to our certificate team requesting a certificate at: techcertrequest@theabdteam.com and CC your ABD Team.

Include the following in your email:
o Include in your email the following: RE: Protocol #, Country
o Attach the Protocol and Informed Consent Form (ICF) documents, if not already provided to ABD

France

France

Clinical Trial Application

France Clinical Trial Quote Request

Clinical Trials Quote Request

Mandated Coverage

Yes

Standard Limits

1.000.000 €/patient
6.000.000 €/protocol
10.000.000 €/year

Tail Coverage

10 years

Data Required to Quote

• Clinical Trial Quote Request
• Protocol and Informed Consent Form in English
• Protocol Title in French
• Site List in English, inclusive of Full Name(s) of Principal Investigator(s), the Hospital(s)/Site Location(s) Address(es) with Area Code. This information is for the carrier files only. Will not be listed on the policy documents.
• Local CRO or EU Representative details (Contact Person Name and Telephone Number). Will be referenced on the Policy declaration page and the Certificate
• Provide EudraCT Number for Drug studies or EUDAMED No. for Medical Device studies, if not already included in Protocol