Tender Results of European Medicines Agency Ema

The European Medicines Agency (EMA) is seeking to sign multiple framework contracts in three different lots for developing a Big Data curriculum to enhance the skills of the EU regulatory network. The Big Data curriculum is composed of the data science curriculum, pharmacoepidemiology and real-world evidence curriculum, biostatistics and clinical trial methodology curriculum and modules in the field of clinical trials. The contractors will develop trainings in these fields that will ensure the provision of first-rate trainings and enable regulators to apply the acquired knowledge in regulatory activities.

The purpose of this procurement procedure is to increase the ceiling of the framework contracts awarded following open procedure EMA/2019/18/IT, contract notice 2019/S 248-611281 for the provision of services, on a time and means basis, quoted time and means or fixed price basis that will enable the Agency to acquire resources not employed directly by the Agency in the domain of IT infrastructure administration, IT security implementation and end user equipment and software management.

The purpose of this tender is to select a contractor for the outsourcing of the DARWIN EU® Coordination Centre and the establishment of technological and methodological services under the instruction and supervision of EMA for the management of the network of data partners and the execution of non-interventional studies within the network. The contractor shall establish the DARWIN EU® Coordination Centre, comprising a technological and business infrastructure and a team operating and overseeing all activities of the DARWIN EU® network of databases.

This call for tender aims to put into place framework contracts, with a maximum of five economic operators for the provision of services, that will enable the Agency to acquire resources, not employed directly by the Agency, in the domain of IT software development, implementation and maintenance. In relation to the listed specific technologies as follows: • in priority order (cascade) for orders on a time and means basis; and • reopening of competition for orders on a quoted time and means or fixed price basis. The Agency estimates, without this being binding, that the total consulting requirement for consulting services over the 4-year framework contract period is expected to represent: — 17 460 person-days for the services pertaining to Microsoft technologies, — 10 698 person-days for the services pertaining to Informatica technologies, — 11 675 person-days for the services pertaining to SAP technologies.

This call for tender aims to put into place framework contracts, with a maximum of five economic operators for the provision of services, that will enable the Agency to acquire resources, not employed directly by the Agency, in the domain of IT software development, implementation and maintenance. In relation to the listed specific technologies as follows: • in priority order (cascade) for orders on a time and means basis; and • reopening of competition for orders on a quoted time and means or fixed price basis. The Agency estimates, without this being binding, that the total consulting requirement for consulting services over the 4-year framework contract period is expected to represent: — 17 460 person-days for the services pertaining to Microsoft technologies.

The purpose of this procurement procedure is to increase the ceiling of the framework contracts awarded following open procedure EMA/2019/13/IT, contract notice OJ S: 2020/S 251-626976 for the provision of services on a time and means basis, quoted time and means or fixed price basis that will enable the Agency to acquire resources not employed directly by the Agency in the domain of IT software development, implementation and maintenance — ‘ESP DIMSIS II’.