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Clinical Trials program is underwritten by a major European
insurer. After a very successful initial Trial Phase,
this facility is now available to the general public.
With the support of a dedicated clinical trials
unit we can turn around quotes quickly to expedite the issue
of required certificates, and to facilitate local policy
issuance.
Unlike in the U.S., where insurance is
typically secured as a bolt on to a domestic Medical Products
Liability policy, we offer clinical trials coverage on a
standalone basis. An important feature to highlight here is
while any bolt on is obviously subject to annual renewal as
part of the overall Medical Products policy, policies issued
via Globex are written for the period of the trial in
question.
Examples
/ Case Studies
CASE STUDY #1
From an initial enquiry
relating to the placement of an admitted policy in Germany for
a study to be undertaken in Frankfurt, we have now assisted
one company in securing coverage for a further six studies in
various territories across Europe.
Prior to working with Globex,
coverage for the client's European trials had been placed in
the U.S. domestic market in accordance with usual market
practice, i.e., via a clinical trials extension to a medical
products liability policy. In addition to experiencing the
usual administrative difficulties relating to the issue of
local policy documentation, the company had also been advised
by the U.S. carrier of a lack of capacity which would limit
their ability to accommodate future international studies.
To date, we have successfully
extended the original German policy to include three more
study sites, two in Berlin and one in Hanover. As all three
additional studies relate to the same trial and all are being
undertaken in the same country, this was the preferred
solution. The period of the policy has simply been extended to
accommodate the expected duration of the longest study.
This client is also undertaking
trials for the same medical device elsewhere in Europe. In
this respect, we have also arranged coverage and the issue of
certificates and policies for studies in Italy, Finland and
France. While coverage in Italy and France is compulsory and
therefore both the certificates and policies have been issued
locally and in local language, this is not the case in
Finland. We have therefore been able to issue documentation in
English via the UK market for the Finnish study.
CASE STUDY #2
As a result of our successes,
we are now assisting the same company with the coverage needs
of another U.S. client whose trial for a medical device
involves studies in Germany and Italy. Clinical trials
coverage is compulsory in both countries and coverage has been
bound and documentation issued accordingly.
CASE STUDY #3
A company had Clinical Trials
coverage in place for a client via a domestic U.S. carrier but
this domestic carrier considered an upcoming French Clinical
Trial too risky and declined coverage.
The company approached Globex
for assistance, and we were able to secure a standalone
quotation. The quote included various options based on varying
levels of patient participation.
Coverage was bound and
documentation issued locally to comply with local regulations.
Request
a Clinical Trials Quote
Policies are generally specific to one
trial, with one limit applying for the duration, a sublimit
per person, and a single premium calculated on the basis of
the number of patients to be involved. However, in the event
that a client is to undertake multiple trials in one country
in the same year, Partner Brokers can, via Globex, also offer
clients coverage under a single policy. In such instances, the
policy will provide one limit for all trials, a sublimit per
person, and a minimum and deposit premium, adjustable upon the
final number of patients.
To secure a quotation for one or a number of
trials, we simply require the following underwriting
information:
- A copy of the protocol;
- A copy of the patient consent form (in
English and in local language as appropriate);
- Confirmation of the number of patients;
- The address of each study site and the
name of the doctor responsible for undertaking the study
at each site; and
- Confirmation of the duration of the
trial.
For immediate attention, please
send this information to Globex at Fax +1 973 541 1145 or globex@globexintl.com.
Contact
Globex for assistance with this extremely important
program.
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