Life Sciences – Clinical Trials
‘To be forewarned is to be forearmed’
This is an area which is clearly by its nature highly technical and must involve consultation with insurers at the earliest opportunity.
Prior to undertaking certain clinical trails full approval must be secured from an Ethics Committee (E C).
However long before any submission to the relevant E C it is vital to ensure insurers have been fully briefed on all aspect of the proposed trial, which should also include;
- The country or countries holding the trial(s).
- Legal liability owed by the Clinical Sponsor
- Disclaimer wording requiring completion by patient volunteers.
If insurers are not involved prior to E C approval being granted there is every possibility insurers may be uncomfortable with certain aspects and will either restrict or in some cases not provide any cover.
If such a scenario were to arise this would cause substantial difficulties, which will result in;
- Delay in starting the trail, while insures consider their position and negotiations take place.
- Possibility may have to consider sourcing an alternative insurance arrangement.
- Postponement of trail and re-submission of proposals to E C.
Finally, if there is a series of trials being conducted multi-nationally, if your insurers have expertise across their global network they will be able to provide invaluable information on local jurisdictions and regulatory issues.
Print Page | Close Window