Two basic pieces of information are :
-the Research Protocol
-the Informed Consent Form (which explains the risks to the patient)
The following are then analyzed:
-the number of patients (total number or random number)
-the number and nature of the countries
-number of centers in each country
It is only with this information, qualitative (protocol, letter) and quantitative (distribution by country / center) that the insurer will be able to give a rate under the assumption that it has also been briefed on the key dates of the trial.
According to the “eClinical Landscape Study” issued by the Tufts Center for the Study of Drug Development, designing and publishing the results of clinical research now takes, on average, 68 days.
With the preceding information, the following can be determined:
-the guarantees, according to each country, with data:
with some minimum legal requirements, for example in France:
per patient per protocol
€ 1 million € 6 million