Risk Management

The client faced several niche issues related to the insurance requirements for conducting clinical trials in Greece. The regulatory framework mandates insurance for interventional clinical studies, while non-interventional studies are recommended to have coverage. A critical challenge was the timely issuance of insurance certificates, which is essential for the completeness of the submission dossier and impacts the study's timeline. Additionally, sponsors, including pharmaceutical companies and research teams, are required to maintain insurance contracts with reliable insurers to cover potential liabilities. To address these challenges, a tailored solution was provided that included comprehensive insurance coverage compliant with regulatory requirements in Greece and abroad. The service ensured the precise and prompt issuance of insurance certificates within 24 hours of the insurance order from the sponsor, thereby safeguarding the study's timeline and preventing delays in authorization and execution. The solution also offered financial protection for sponsors and participating researchers, along with legal support in case of claims, ensuring a robust safety net for all parties involved. The results of implementing this solution were significant. The client benefited from broad insurance coverage with adequate limits from reputable insurance markets, specifically tailored for the life sciences sector. This not only protected the financial health of the sponsors but also enhanced the stability and safety of the research environment, promoting the conduct of new clinical trials. Furthermore, the service provided support to Contract Research Organizations (CROs) in securing the necessary insurance coverage, allowing them to allocate human resources more efficiently to other study tasks. The establishment of multinational programs that met local insurance requirements also facilitated economies of scale and uniformity in coverage across different countries, streamlining the process for sponsors managing studies in multiple jurisdictions.