New application to improve management of clinical trials

The Finnish Medicines Agency Fimea and the Dutch Central Committee on Research Involving Human Subjects (CCMO) have agreed on significant cooperation in which the CCMO will make the application it has developed available to Fimea. The application will improve the management of clinical trials and serve as a tool between the CTIS portal and assessors. The cooperation marks a significant step towards a more efficient and well-managed research process in Finland.

“The application is used to allocate tasks and manage trials being assessed in Finland,” says Kaisa Sunela, Head of Division at Fimea.

The CTIS (Clinical Trials Information System) is a joint portal for EU pharmaceutical authorities where clinical trial activities take place. The Central Committee on Research Involving Human Subjects (CCMO) is a Dutch authority responsible for the supervision and regulation of clinical trials.

“The agreement in question is an intellectual property contract. I am pleased that we can engage in this kind of cooperation with other EU Member States,” says Jukka Räisänen, Fimea’s lawyer.

Fimea to further develop the application

At the Fimea Clinical Trials Division, the application will affect in particular the management of research resources, compiling of statistics and the division of tasks. In practice, Fimea is getting the application from the CCMO and will develop it further for its own use.

The change will significantly facilitate the work of coordinators and assessors. The application will cut down the workload of coordinators.

“It will be used to produce better statistics on different trials than is currently possible through the CTIS portal. In addition, the work time of coordinators will be freed up for other work such as holding researcher workshops or other development,” says Kaisa Sunela, Head of Division.

Representatives of the CCMO will provide orientation training to Fimea’s personnel on the use of the new application in the coming summer. Fimea will soon receive the first version of the application. The further development of the application will take around six months.