Sandra Pla, COO of Synapse Research Management Partners, participated on June 1 at the XV Conference of Biomedical Research Technology Platforms as a member of a round table on 'Digital Transformation in Biomedical Research'.
In a round table that brought together different experts, representing the vision of professionals, patients, the pharmaceutical industry, as well as project management, members discussed key aspects related to the challenges and opportunities presented by digital transformation in the field of biomedical research. The event was viewed by more than 700 people via streaming.
Sandra Pla had the opportunity to present the initiative recently launched by the European Medicines Agency on the creation of the Real World Data Analysis and Interrogation Network Coordination Centre: 'DARWIN EU®', which aims to provide all national regulators with access to reliable real-world evidence, on diseases, patient populations and the use, safety and efficacy of medicines.
When asked what it means for hospitals and SMEs to participate in the European IMI EHDEN project, Sandra Pla commented that one of the main advantages for hospitals, if they participate in the IMI EHDEN project (there is a specific process to apply through public calls), is that their data would be mapped or standardized to the OMOP common data model. With this, hospitals could participate in research studies faster, participate as members of the 'real world evidence' environment, and have the opportunity to collaborate within an open scientific community.
SMEs can also participate in EHDEN since specific calls have been created for them to be certified by the project. Here, SMEs would validate that data partners (hospitals, for example) have correctly mapped their data to the OMOP common data model. In this sense, an immediate benefit for an SME would be to gain a comparative advantage as they can expand their market and have a pioneering role in healthcare data analysis.
EHDEN currently has 22 Spanish databases mapped to OMOP and 5 SMEs certified by the project.
Sandra Pla also shared the advantages of the federated data system, which simplifies the task of sharing and analyzing information, eliminates the need for users to move data, and reduces the challenges associated with secure access to multiple systems.
These functions are important to help maintain data privacy and respect data protection regulations, such as the data privacy regulation in Europe, known as GDPR (General Data Protection Regulation).
By being federated, effort is distributed among all parties involved, making this type of data system more sustainable in the long run.