Netherlands

Netherlands

Netherlands

Netherlands

Clinical Trial Application

Netherlands Clinical Trial Quote Request

Clinical Trials Quote Request

Mandated Coverage

Yes. www.ccmo.nl/en/insurance

Standard Limits

450.000 €/patient
3.500.000 €/protocol

Effective July 1, 2015, new limits required are:
650.000 €/patient
5.000.000 €/protocol

Tail Coverage

4 years from the end of patient treatment

Data Required to Quote

• Clinical Trial Quote Request
• Protocol and Informed Consent Form in English
• Protocol Title in Dutch

- There are TWO insurance requirements.
- Local admitted clinical trial insurance satisfies the G1 patient indemnity insurance requirement according to WMO
- The G2 is the liability insurance of Sponsor, which can be covered via a global product liability policy
- Therefore to satisfy G2, if the Sponsor has a Master Product Liability policy through Newfront, Newfront can provide a certificate

India

India

Clinical Trial Application

India Specific Clinical Trial Quote Request

Mandated Coverage

Yes

Standard Limits

From 1 to 5 Million USD in aggregate

Tail Coverage

6 months (up to 1 year available for an additional premium)

Data Required to Quote

• Country-specific Application and Application must be printed and signed PRIOR to binding coverage
• Protocol and Informed Consent Form in English
• A local entity must be named as the Policyholder (Investigator or CRO)

- No refund for policy cancellation
- India requires payment to the carrier PRIOR to release of certificate

To bind coverage:
• provide Permanent Account Number (PAN) of the Local CRO. PAN number is a ten-digit alphanumeric number, issued in the form of a laminated card by the Income Tax Department
• provide Good and Services Tax (GST) number of the Local CRO

Please allow additional time for processing. Please allow at least one month before issuance of policy documents