For years electronic exchange of ICSRs with the EudraVigilance database in an e2b-compliant standard has become mandatory for all MAHs of medicinal products. However, ICSRs from the CRO’s clinical database to the MAHs in both, non-interventional studies and clinical trials, are still transmitted paper-based or in electronic portable document format (pdf).
The benefits of using the e2b standard in exchange of ICSRs between the CRO and the MAH are hardly recognized, in particular the automated and highly efficient fail-safe transfer of validated datasets ready for immediate processing. Alcedis’ long-term experience in implementing customized requirements in pharmacovigilance as part of the AlcedisTRIAL software is the key for next level data exchange beween clincial and safety databases: Alcedis is ready for e2b (R3)!
Are you too? Our IT and pharmacovigilance experts are glad to customize the perfect e2b (R3) solution for you!