EudraVigilance data management — increase in ceiling

Tender description

This tender aims to put into place contractual arrangements that will enable the EMA to specify and acquire services provided by resources not employed directly by the EMA. These resources will contribute expertise directly to the data management activities (manual recoding, duplicate detection and quality control for both XEVMPD and ICSR data) for EudraVigilance, the Agency's pharmacovigilance system. The results of the work are to be stored electronically on the systems hosted at the Agency. Tracking information in relation to the tasks is to be maintained by the contractor and made available to the EMA electronically. The results of the work are to be presented to EMA weekly, work stream by work stream. The work is to be performed at the contractor's premises; although the contractor's staff will be expected to attend meetings at EMA's premises at 30 Churchill Place, Canary Wharf, London, E14 5EU, United Kingdom. This tender aims to put into place contractual arrangements that will enable the EMA to specify and acquire services provided by resources not employed directly by the EMA. These resources will contribute expertise directly to the data management activities (manual recoding, duplicate detection and quality control for both XEVMPD and ICSR data) for EudraVigilance, the Agency's pharmacovigilance system. The results of the work are to be stored electronically on the systems hosted at the Agency. Tracking information in relation to the tasks is to be maintained by the contractor and made available to the EMA electronically. The results of the work are to be presented to EMA weekly, work stream by work stream. The work is to be performed at the contractor's premises; although the contractor's staff will be expected to attend meetings at EMA's premises at 30 Churchill Place, Canary Wharf, London, E14 5EU, United Kingdom.