Data Management

Building Your Future

CRO Data Management Team

Ana Patacão, Global Director and Pedro Noronha, Senior Data Manager

Our Data Management unit understands each sponsor’s requirements will need a customized resourcing and financial models tailored to best fit their strategy.

Eurotrials’ clinical data management systems and databases are developed considering the maximization of efficiencies, enabling swift trial configuration, improve data monitoring, and faster database locks.

Giving the increasingly complexity of clinical trials nowadays, the clinical trial data is suffering an aggressive growth. This means there are much more data to be gathered, analysed and organized to comply with the Regulatory requirements for safety monitoring.

Innovative eClinical technologies are essential to manage these requirements, reduce costs, and support faster decisions throughout the product development lifecycle.

Our solution for this complexity is our newest contracted partner, Merge, an IBM Company, which offers a fully integrated eCOS platform:

Data Management eClinical

By Therapeutic Area:

CRO Data Management Expertise

Study Planning

  • Electronic Data Capture (EDC), FDA 21 CFR Part 11 compliant, with Merge eClinical OS.
  • Codification of medical terms and medication;
  • Database development using different softwares;
  • Case Report Forms development (paper CRF and eCRF);

Collection and Information Processing

  • Advanced Reporting tool
  • Inventory and Dispensing tool
  • IWRS
  • Electronic Patient Reported Outcomes (ePRO)
  • Manage Image and Endpoint Adjudication
  • Lab normal
  • Training module
  • Project specific WEB portals for Late Phase studies

Final Data

  • Standards Implementation (CDISC– CDASH, SDTM);
  • Autoencoder for MedDRA
  • Report/Export data